[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pfizer\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":699},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,141,0,25,[9,48,71,93,131,161,186,224,258,294,321,344,385,405,432,451,475,506,537,559,587,608,634,654,677],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100450410",false,"NCT05145127","Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors","AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF MARSTACIMAB PROPHYLAXIS IN SEVERE (COAGULATION FACTOR ACTIVITY \u003C1%) HEMOPHILIA A PARTICIPANTS WITH OR WITHOUT INHIBITORS OR MODERATELY SEVERE TO SEVERE HEMOPHILIA B PARTICIPANTS (COAGULATION FACTOR ACTIVITY ≤2%) WITH OR WITHOUT INHIBITORS","Inclusion Criteria:\n\n* All participants will have a minimum body weight as defined by parent studies\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Participants have successfully completed participation in parent studies, defined as did not require \"Early Termination\"\n\nExclusion Criteria:\n\n* Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis (CTCAE Grade \\>3), or ischemic disease (except catheter-associated thrombosis)\n* Abnormal renal function as defined by eGFR \\\u003C30 mL.min\u002F1.73 m(2)\n* Known planned surgical procedure during the planned study period\n* Unstable hepatic function as determined by the Investigator clinical assessment and review of the participant's most recent laboratory results, which would make the participant inappropriate for the study\n* For participants known to be HIV+, worsening disease status as determined by the Investigator clinical assessment and review of participant's most recent laboratory results, to include recent locally available CD4 count (if available), which would make the participant inappropriate for the study\n* Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic corticosteroids, rituximab)\n* Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study\n* Participation in other study involving investigational drug(s) or investigational vaccine(s) within 30 days or 5 half-lives prior to or during study participation, with the exception of participation in parent studies\n* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the Investigator, and their respective family members","MALE","1 Year","74 Years",{"count":20,"type":21},245,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require \"Early Termination\" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008.\n\nStudy B7841005: approximately 145 adolescent and adult participants 12 to \\\u003C75 years of age with severe hemophilia A or moderately severe to severe hemophilia B (defined as FVIII activity \\\u003C1% or FIX activity ≤2%, respectively) with or without inhibitors are expected to be enrolled in Study B7841005 during which they will receive prophylaxis (defined as treatment by SC injection of marstacimab).\n\nStudy B7841008: this is an ongoing Phase 3, open-label study in pediatric participants \\\u003C18 years of age with severe hemophilia A (FVIII Coagulation Factor Activity \\\u003C1%) or moderately severe to severe hemophilia B (FIX Coagulation Factor Activity ≤2%). A sequential approach will be used in enrolling at least 100 pediatric participants, at least 20 of which will be aged ≥12 to \\\u003C18 years and at least 80 participants will be aged ≥1 to \\\u003C12 years. At the start of study B7841008, the dosing and data available in adolescent and adult participants in Study B7841005 supported the initiation of B7841008 study in participants aged ≥12 to \\\u003C18 years. Subsequently, additional safety and efficacy data from adolescent participants in Study B7841005 became available for benefit\u002Frisk assessment in support of dosing participants aged ≥6 to \\\u003C12 years. Based on the positive benefit\u002Frisk assessment conducted by both internal Pfizer review and eDMC review, dosing of the ≥6 to \\\u003C12 years age group was initiated in June 2023 in B7841008 Study. Data from participants ≥6 years from B7841008 Study and Study B7841005 will support the dosing of participants aged ≥1 to \\\u003C6 years.\n\nAll participants will be provided the prefilled pen (PFP) for administration of marstacimab in the study. Use of the prefilled syringe (PFS) will be permitted at the investigator's discretion for those participants who have difficulty with administration of the PFP. Additionally, participants will be provided the PFS for use in this study in countries where the PFS is anticipated to be the only presentation available commercially. An optional, open-label, single arm, substudy using the PFP was completed in the first 23 participants rolled over from Study B7841005 who agreed to participate in the substudy.",[27,28],"Hemophilia A","Hemophilia B",[30,31,32,33,34],"Factor VIII Inhibitor","Factor IX Inhibitor","PF-06741086","Marstacimab","Anti-TFPI","RECRUITING","2026-06-30",{"date":38,"type":39},"2026-07-01","ACTUAL",{"date":41,"type":39},"2021-11-17",{"date":43,"type":21},"2030-07-31",{"name":45,"class":46},"Pfizer","INDUSTRY",75,{"id":49,"slug":4,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100643737","NCT07609914","A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine","A PHASE 4, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF REDOSING OF RIMEGEPANT IN PARTICIPANTS 18 YEARS OF AGE OR OLDER FOR THE ACUTE TREATMENT OF MIGRAINE","Inclusion:\n\n* Eligible participants include adult participants aged 18 years of age or older with a minimum 1-year history of migraine (with or without aura) consistent with International Classification of Headache Disorders, 3rd Edition\n* Eligible participants must be currently using acute migraine treatment in accordance with the local label and have all of the following on average across the 12 weeks prior to the Screening Visit and, during the first 28 days of the observation phase (OP): (1) 6-14 monthly migraine days (MMDs); (2) \\\u003C15 monthly headache days (MHDs) (migraine or non-migraine); and (3) \\\u003C7 monthly non-migraine headache days.\n\nExclusion:\n\n* Participants with headaches occurring ≥15 days per month (migraine or non-migraine) on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine headache days per month on average across the 12 weeks prior to the Screening Visit would not be eligible.","ALL","18 Years",{"count":57,"type":21},400,[59],"PHASE4","Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack.\n\nThe primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.",[62],"Acute Treatment of Migraine","2026-06-29",{"date":38,"type":39},{"date":66,"type":39},"2026-05-28",{"date":68,"type":21},"2028-05-15",{"name":45,"class":46},6,{"id":72,"slug":4,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":54,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100611039","NCT07235397","Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset","Evaluating the Benefits Of RSV MaternaL vAccination Using a Scottish National Dataset.","BORLAND","Infants must meet all inclusion criteria to be eligible for inclusion in the study:\n\n1. Live birth in Scotland from 1st September 2024 to 28th February 2026\n2. Gestational age at birth ≥28(0\u002F7) weeks of gestation (earliest gestational age eligible for ABRYSVO vaccination)\n\nInfants meeting any of the following criteria will not be included in the study:\n\n1. Born to a mother who received any licensed or investigational RSV vaccine other than ABRYSVO at any time during pregnancy\n2. Meets UK national guidelines for monoclonal antibody receipt","0 Years","12 Months",{"count":81,"type":21},1,"OBSERVATIONAL","This study will use a retrospective cohort design and will be conducted within routinely collected national healthcare and statutory demographic datasets held by PHS and National Records of Scotland (NRS). As such, there will be no active enrollment of study participants, no direct contact with study participants, no collection of any primary data outside of the standard of care (SOC), and no requirement for informed consent.\n\nThis study design was chosen due to several advantages, over other possible designs, including the ability to evaluate incidence of study outcomes in exposed and unexposed infants, ability to follow infants longitudinally to evaluate study outcomes through 12 months of age, and ability to evaluate all-cause outcomes.\n\nStudy endpoints, including RSV-associated LRTD hospitalization and RSV-associated hospitalization, among infants born to ABRYSVO-vaccinated mothers (exposed group) will be compared with those among infants born to ABRYSVO-unvaccinated mothers (comparison group) initially from birth through 6 months of age, with later analysis from birth through 12 months as the infants reach this age threshold and their data become available.",[85],"Respiratory Syncytial Virus Infections","NOT_YET_RECRUITING",{"date":38,"type":39},{"date":89,"type":21},"2026-07-30",{"date":91,"type":21},"2026-11-13",{"name":45,"class":46},{"id":94,"slug":4,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},"100593979","NCT07013474","A Study to Learn About the Study Medicine Ibuzatrelvir in Adults With COVID-19 Who Are Severely Immunocompromised","AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE IBUZATRELVIR IN ADULTS WITH SYMPTOMATIC COVID-19 WHO ARE SEVERELY IMMUNOCOMPROMISED","Inclusion Criteria:\n\n1. 18 years of age or older at screening who are non-hospitalized or hospitalized for observation or with the intent of administering the study intervention.\n2. Confirmed SARS-CoV-2 infection as determined by RAT (or other locally approved test) collected within 2 days prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization.\n3. Severely immunocompromised due to:\n\n   * Solid organ or islet cell transplant recipient who is receiving immunosuppressive therapy;\n   * Active hematologic malignancy (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia);\n   * Receipt of CAR-T-cell therapy or HCT either within 2 years of transplantation or who are receiving immunosuppressive therapy;\n   * Currently receiving or recently received B-cell depleting therapies (eg, rituximab), where the immunosuppressive effect is still ongoing.\n\nExclusion Criteria:\n\n1. Severe COVID-19, or current need for supplemental oxygen for treatment of COVID-19.\n2. Receiving dialysis or have current kidney failure (ie, eGFR consistently \\\u003C15 mL\u002Fmin\u002F1.73 m2)\n3. Active liver disease\n4. History of hypersensitivity or other contraindication to any of the components of the study interventions, as determined by the investigator\n5. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.\n6. Life expectancy less than 30 days at study entry due to an underlying condition, in the judgement of the investigator.\n7. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n8. Has received any other antiviral for the treatment of the current COVID-19 infection\n9. Current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).\n10. Current or previous administration of an investigational product (drug or vaccine) within 30 days (or as determined by local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). Authorized or products with conditional approval are not considered investigational.\n11. Prior participation in this trial or any clinical trial of ibuzatrelvir.\n12. Females who are pregnant, breastfeeding, or who are planning to become pregnant within the timeframe of the study.\n13. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.",{"count":100,"type":21},300,[24],"This is a Phase 3, randomized, actively controlled, double-blinded, double-dummy, superiority study to evaluate the efficacy and safety of ibuzatrelvir alone and in combination with remdesivir IV compared to remdesivir IV alone for the treatment of symptomatic COVID-19 in severely immunocompromised adult participants who are non-hospitalized or are hospitalized for observation or study intervention administration but do not require supplemental oxygen for COVID-19.",[104],"COVID-19 Infection",[106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123],"COVID-19 infection","pneumonia","respiratory tract infections","coronavirus infection","RNA virus infection","lung disease","pneumonia, viral","infections","virus","viral protease inhibitor","protease inhibitor","enzyme inhibitor","severe immunocompromise","anti-viral agents","anti-infectives","ibuzatrelvir","remdesivir","COVID-19",{"date":38,"type":39},{"date":126,"type":39},"2025-07-14",{"date":128,"type":21},"2028-02-25",{"name":45,"class":46},148,{"id":132,"slug":4,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":141,"conditions":142,"keywords":145,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},"100592131","NCT06989437","A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue","A Phase 2b\u002F3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma","Key inclusion Criteria:\n\n* Signed Informed Consent Document\n* Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma\n* Cachexia defined by Fearon criteria of weight loss\n* Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy\n* ECOG PS ≤1 with life expectancy of at least 4 months\n\nKey Exclusion Criteria:\n\n* Current active reversible causes of decreased food intake\n* Cachexia caused by other reasons\n* Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification\n* Left ventricular ejection fraction \\\u003C50%\n* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization\n* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody\n* History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients\n* Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases\n* Inadequate liver function\n* Renal disease requiring dialysis or eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2",{"count":138,"type":21},982,[140,24],"PHASE2","Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.",[143,144],"Cachexia","Metastatic Pancreatic Ductal Adenocarcinoma",[146,147,148,149,150,151,152,153],"pancreatic cancer","metastatic cancer","cancer","anorexia","cachexia","weight loss","loss of appetite","fatigue",{"date":38,"type":39},{"date":156,"type":39},"2025-10-03",{"date":158,"type":21},"2029-12-10",{"name":45,"class":46},211,{"id":162,"slug":4,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":167,"sex":54,"minAge":78,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":179,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100582676","NCT06866405","A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose","A Phase 3 Study to Investigate the Safety, Tolerability, and Immunogenicity of Revaccinating Pregnant Participants During Subsequent Pregnancies and Persistence of Immunity of a Single Dose of a Bivalent Respiratory Syncytial Virus (RSV) Vaccine.","Pregnant Participants-Cohort 1 and Cohort 2 Key Inclusion Criteria\n\n* Women aged 18 to 49 who are pregnant, between 24 and 36 weeks along, and expecting one baby without known risks for complications can participate.\n* Had the RSVpreF or Abrysvo vaccine during a previous pregnancy.\n* Had an ultrasound scan at 18 weeks or later during their current pregnancy, with no major fetal problems detected.\n* Based on their medical history, physical check-up, and the doctor's judgment, they are found suitable to join the study.\n* Agrees to let their baby take part in the study and gives their permission.\n* Able to sign a consent form, agreeing to follow the rules and conditions of the study.\n\nKey Exclusion Criteria\n\n* Received any approved or experimental RSV vaccine since their previous pregnancy.\n* Has a pre-pregnancy body mass index (BMI) over 40 kg\u002Fm2.\n* History of a severe bad reaction to a vaccine or a serious allergic reaction (like anaphylaxis) to any ingredient in the study vaccine or a similar vaccine.\n* Current pregnancy problems or issues at the time of giving consent.\n* Previous pregnancy issues or problems at the time of giving consent.\n* Women who are breastfeeding at the time of enrollment\n\nInfant Participants\n\n* Proof that the parent(s) or legal guardian(s) has signed and dated a consent form.\n* Parent(s) or legal guardian(s) must agree to attend scheduled visits and follow the study plan, including laboratory tests and other procedures.\n\nNonpregnant Participants-Cohort 3 Key Inclusion Criteria\n\n* Have already received one dose of the RSVpreF vaccine during their previous pregnancy as part of the Pfizer clinical trial, and the results from that time can be used for this study.\n* Able to sign a consent form, agreeing to follow the rules and requirements of the study.\n\nKey Exclusion Criteria\n\n* Received any approved or experimental RSV vaccine after participating in the Pfizer clinical trial.\n* Taking part in other studies with new drugs within 28 days before giving consent or during the study period.",true,{"count":169,"type":21},550,[24],"This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.",[173],"RSV Infection",[175,176,177,178],"Pregnancy","RSV vaccine","RSV","Maternal immunization",{"date":38,"type":39},{"date":181,"type":39},"2025-04-16",{"date":183,"type":21},"2028-02-24",{"name":45,"class":46},97,{"id":187,"slug":4,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":54,"minAge":192,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":199,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},"100568278","NCT06679140","A Study to Learn About a Study Medicine Called Ibuzatrelvir in Adult and Adolescent Patients With COVID-19 Who Are Not Hospitalized But Are at Risk For Severe Disease","AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED IBUZATRELVIR COMPARED WITH PLACEBO IN NON-HOSPITALIZED SYMPTOMATIC ADULT AND ADOLESCENT PARTICIPANTS WITH COVID-19 WHO ARE AT HIGH RISK OF PROGRESSING TO SEVERE ILLNESS","Inclusion Criteria:\n\n1. 12 to \\\u003C18 years of age, weighing at least 40 kg, or ≥18 years of age of any weight at screening.\n2. Presence of risk factors for progression to severe COVID-19 at the time of screening based on age:\n\n   1. 12 to 49 years of age with at least two risk factors, where one must be moderate immunocompromise;\n   2. 50 to 64 years of age with at least two risk factors;\n   3. 65 to 74 years of age with at least one risk factor;\n   4. For participants 75 years of age or older, there are no requirements related to risk factors.\n\n   The list of risk factors includes:\n\n   BMI ≥35 kg\u002Fm2; Current smoker; Chronic lung disease; Cardiovascular disease; Type 1 or Type 2 diabetes mellitus; Mild to moderate renal impairment; Neurodevelopmental disorders; Sickle cell disease; Moderate immunosuppression.\n3. Confirmed SARS-CoV-2 infection as determined by RAT in nasal or NP specimen collected within 1 day prior to randomization. Initial onset of symptoms attributable to COVID-19 within 5 days prior to randomization and at least 1 of the specified symptoms attributable to COVID-19 present on the day of randomization. Randomization must occur no later than the 5th day, where the onset of symptoms is the first day.\n4. Participants must be unable or unwilling to take nirmatrelvir\u002Fritonavir.\n\nExclusion Criteria:\n\n1. Current need or anticipated need for hospitalization within 24 hours, due to signs of severe COVID-19 illness (eg, SpO2 \\\u003C94% on room air, respiratory rate \\>30 breaths\u002Fminute, or lung infiltrates \\>50%) or due to other medical conditions requiring hospitalization in the opinion of the site investigator.\n2. Receiving dialysis or have known severe renal impairment \\[ie, eGFR consistently \\\u003C30 mL\u002Fmin\u002F1.73 m2 for adults or CrCl \\\u003C30 mL\u002Fmin for adolescents\\], using the serum creatinine-based CKD-EPI formula or the Cockroft Gault, respectively.\n3. Active liver disease with AST or ALT \\>3 ULN, Total bilirubin ≥2 × ULN (for Gilbert's syndrome, direct bilirubin \\>ULN is exclusionary) within the past 3 months, or liver function impairment with Class C per Child Pugh classification.\n4. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.\n5. Ongoing Long COVID or Post Acute Sequelae of COVID-19 diagnosis.\n6. Severely immunocompromised.\n7. Any comorbidity requiring hospitalization and\u002For surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.\n8. History of hypersensitivity or other contraindication to any of the components of the study interventions.\n9. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n10. Current use of any prohibited concomitant medication(s).\n\n10.Has received any other antiviral for the treatment of COVID-19, including remdesivir, nirmatrelvir\u002Fritonavir, molnupiravir, or COVID-19 mAbs within 30 days or 5 half-lives \\[whichever is longer\\] prior to screening, or received convalescent COVID-19 plasma within 12 months.\n\n12.Received any dose of a COVID-19 vaccine within 4 months of randomization or expected to receive one through Day 34.\n\n13.Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).\n\n14.Prior participation in this clinical trial or any other clinical trial of ibuzatrelvir.\n\n15.Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","12 Years",{"count":194,"type":21},2330,[24],"The purpose of the study is to evaluate whether ibuzatrelvir is effective and safe in adults and adolescents with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible participants will be randomly assigned (by chance) to receive ibuzatrelvir or matching placebo orally for 5 days. Co-administration of locally available standard of care is allowed. The total duration of the study is around 6 months.",[198],"COVID-19 SARS-CoV-2 Infection",[200,201,202,203,204,205,206,207,208,209,210,123,211,212,213,214,215,216,121],"Pneumonia, Viral","Pneumonia","Respiratory Tract Infections","Infections","Virus Diseases","Coronavirus Infections","Coronaviridae Infections","Nidovirales Infections","RNA Virus Infections","Lung Diseases","Respiratory Tract Diseases","Viral Protease Inhibitors","Protease Inhibitors","Enzyme Inhibitors","Molecular Mechanisms of Pharmacological Action","Antiviral Agents","Anti-Infective Agents",{"date":38,"type":39},{"date":219,"type":39},"2024-12-08",{"date":221,"type":21},"2028-03-02",{"name":45,"class":46},247,{"id":225,"slug":4,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},"100564484","NCT06629779","A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.","A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF PF-06821497 (MEVROMETOSTAT) WITH ENZALUTAMIDE IN METASTATIC CASTRATION RESISTANT PROSTATE CANCER (MEVPRO-2)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.\n* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT\u002FMRI scan.\n* Progressive disease in the setting of medical or surgical castration.\n* ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.\n* Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.\n* Clinically significant cardiovascular disease.\n* Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.\n* Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.\n* Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4\u002F6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:\n\n  1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;\n  2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.\n* Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).\n* Inadequate organ function.",{"count":231,"type":21},900,[24],"This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.",[235],"Metastatic Castration-Resistant Prostate Cancer",[237,238,239,240,241,242,243,244,245,246,247,248,249,250],"MEVROMETOSTAT","METASTATIC CASTRATION RESISTANT PROSTATE CANCER","PF-06821497","EZH2","enhancer of zeste homologue-2","enzalutamide","mCRPC","Prostrate Cancer","castrate resistant prostate cancer","prostatecancer-study.com","efficacy","safety","pharmacokinetics","pharmacodynamics",{"date":38,"type":39},{"date":253,"type":39},"2024-10-22",{"date":255,"type":21},"2028-11-30",{"name":45,"class":46},241,{"id":259,"slug":4,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":287,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":293},"100527808","NCT06152575","MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)","A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED\u002FREFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY","Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.\n* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.\n* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g\u002FdL; (b) Urinary M-protein excretion ≥200 mg\u002F24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Have clinical laboratory values within the specified range.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.\n* Not pregnant or breastfeeding and willing to use contraception.\n\nExclusion Criteria:\n\n* Smoldering multiple myeloma.\n* Plasma cell leukemia.\n* Amyloidosis.\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.\n* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.\n* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.\n* Any active, uncontrolled bacterial, fungal, or viral infection.\n* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)\n* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.\n* Unable to receive investigator's choice therapy.\n* Live attenuated vaccine within 4 weeks of the first dose of study intervention.\n* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.",{"count":265,"type":21},492,[24],"The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).\n\nThis study is seeking participants who:\n\n* Are 18 years of age or older and have MM.\n* Have received treatments before for MM.\n* Have MM that has returned or not responded to their most recent treatment.\n\nHalf of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.\n\nElranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.\n\nThe medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:\n\n* a shot under the skin at the study clinic\n* through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.\n\nParticipants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).\n\nThe study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.",[269],"Multiple Myeloma",[271,272,273,274,275,276,277,278,279,280,281,282,283,284,285,286],"Elranatamab","B-Cell Maturation Antigen","BCMA","Bispecific antibody","BCMA-CD3 bispecific antibody","Myeloma","Multiple myeloma","Relapsed multiple myeloma","Refractory multiple myeloma","MagnetisMM","MagnetisMM-32","Pomalidomide","Elotuzumab","Bortezomib","Carfilzomib","PF-06863135",{"date":38,"type":39},{"date":289,"type":39},"2024-02-08",{"date":291,"type":21},"2027-12-30",{"name":45,"class":46},271,{"id":295,"slug":4,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":306,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":314,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":320},"100520502","NCT06057402","Elranatamab Post Trial Access Study for Participants With Multiple Myeloma (MM)","ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES","MagnetisMM15","Inclusion Criteria:\n\n* Participants must agree to follow the reproductive criteria as outlined in the protocol\n* Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.",{"count":302,"type":21},80,[59],"This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.",[269],[269,271,307,308,309,310,299,273,311,312,274,313],"Post Trial Access","Roll-over Study","Extension Study","MM-15","BCMA antibody","Magnetism","Elrexfio",{"date":38,"type":39},{"date":316,"type":39},"2023-10-03",{"date":318,"type":21},"2032-02-22",{"name":45,"class":46},33,{"id":322,"slug":4,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":54,"minAge":327,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":22,"phases":331,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":343},"100488402","NCT05639647","Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections","A PHASE 2A MULTICENTER, OBSERVER-BLINDED, RANDOMIZED 2 ARM STUDY TO INVESTIGATE PHARMACOKINETICS, SAFETY, TOLERABILITY AND EFFICACY OF INTRAVENOUS AZTREONAM-AVIBACTAM ± METRONIDAZOLE COMPARED TO BEST AVAILABLE THERAPY (BAT) IN PEDIATRIC PARTICIPANTS 9 MONTHS TO LESS THAN 18 YEARS OF AGE WITH SERIOUS GRAM-NEGATIVE BACTERIAL INFECTIONS INCLUDING COMPLICATED INTRA-ABDOMINAL INFECTION","Inclusion Criteria\n\nParticipants must meet the following key inclusion criteria to be eligible for enrollment into the study:\n\n1. Participants ≥9 months to \\\u003C18 years of age at Screening; Female (post-menarchal) participants must have a negative serum\u002Furine pregnancy test (β hCG sensitivity ≥25 mIU\u002FmL).\n2. Suspected\u002Fconfirmed cIAI, cUTI, HAP\u002FVAP, or BSI with gram-negative pathogens.\n3. Require hospitalization and IV antibiotic treatment.\n\nExclusion Criteria\n\nParticipants with any of the following characteristics\u002Fconditions will be excluded:\n\n1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n2. Gram-negative species not expected to respond to ATM AVI ≤14 days.\n3. Pregnant or breastfeeding; fertile male\u002Ffemale unwilling\u002Funable to use effective contraception for at ≥7 days (males) or ≥28 days (females) after last ATM-AVI infusion.\n\n   (HAP\u002FVAP only):\n4. Microbiologically known or high likelihood of monomicrobial infection with a gram-positive organism, lung abscess, pleural empyema, or post-obstructive pneumonia, lung or heart transplant.\n5. Received \\>24 hours of systemic antibiotics during the 48 hours before randomization unless participant has documented treatment failure after at least 48 hours of antibiotic therapy.\n6. Current use of any prohibited concomitant medication(s) or unwilling\u002Funable (Cockayne Syndrome patients with cIAI are excluded) to use MTZ or having received previous investigational drug(s) or vaccine ≤30 days or 5 half-lives before randomization (whichever is longer).\n7. CrCL ≤15 mL\u002Fmin\u002F1.73 m2 (eCrCl or eGFR calculation based on age).\n8. Non-infectious related screening ALT or AST \\>3 x ULN, ALP \\>3 x ULN and\u002For TBili \\>2 x ULN (\\> 3 x ULN for Gilbert's syndrome).\n9. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","9 Months","17 Years",{"count":330,"type":21},48,[140],"The purpose of this study is to evaluate how Aztreonam (ATM) and Avibactam (AVI) are processed in pediatric participants. This study also aims to understand participant safety and effects in pediatric participants.\n\nThe study is seeking participants who are:\n\n* 9 months to less than 18 years of age\n* Hospitalized\n* Suspected\u002Fknown to have a gram-negative infection\n* Receiving intravenous (iv, given directly into a vein) antibiotics\n* Being treated for complicated infections of various body parts that includes the abdomen, urinary tract, blood stream, and lungs.\n* Participants will receive either ATM-AVI or best available therapy (BAT).\n* Both therapies will be given through a vein.\n* Participants with complicated abdominal infections will also receive iv Metronidazole (MTZ). Patients with cIAI and Cockayne Syndrome are excluded due to a risk of severe hepatotoxicity with the use of MTZ. - Participants on ATM-AVI treatment who have anaerobic infections will also receive iv MTZ at the study doctor's discretion.\n* The iv dose of ATM-AVI will be based on the participant's weight and kidney function.\n* The study doctor will determine the iv dose of BAT.\n* During the first 2 study days, participants on ATM-AVI therapy will have 5 blood draws in small quantities.\n* Starting on day 4, the study doctor will decide if participants may be switched to oral therapy.\n* Participants will receive a maximum of 14 days of ATM-AVI treatment.\n* After discharge from the hospital, 1 study visit may be required.\n* Depending on the participant's response, the study duration will be from 33 to 50 days.\n* The investigator will contact participants by phone 28 to 35 days after the last study treatment to check participants health status.",[334],"Gram-negative Bacterial Infections",[336],"Gram-negative bacterial infections",{"date":38,"type":39},{"date":339,"type":39},"2023-04-18",{"date":341,"type":21},"2027-03-31",{"name":45,"class":46},23,{"id":345,"slug":4,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":54,"minAge":350,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":353,"briefSummary":355,"conditions":356,"keywords":370,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":384},"100480603","NCT05538130","A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors","A PHASE 1A\u002FB OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH BRAF-MUTANT MELANOMA AND OTHER SOLID TUMORS","Phase 1b Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor (excluding colorectal cancer)\n* Measurable disease by RECIST version 1.1\n* Evidence of a BRAF V600 mutation\n* Prior therapy per tumor cohort\n* Adequate organ function per protocol\n\nPhase 1b Exclusion Criteria:\n\n* Other active malignancy within 3 years\n* Presence of leptomeningeal disease\n* History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK)\n* Active gastrointestinal disease as defined per protocol\n* History of interstitial lung disease as defined per protocol","16 Years",{"count":352,"type":21},124,[354],"PHASE1","The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) alone or in combination as a potential cancer treatment for adults with advanced solid tumors. The study will be conducted in two parts: PF-07799544 as a single agent (Phase 1a) and PF-07799544 in combination with another study medicine called PF-07799933 (Phase 1b).\n\nPhase 1a is no longer open for enrollment. In Phase1b (noted as \"this study\"), we are seeking participants who have:\n\n* a solid tumor which is metastatic or recurrent (excluding colorectal cancer)\n* tumor with the mutation (abnormal gene) called \"BRAF V600\"\n* received required prior treatment for cancer per cohort assigned.\n\nAll participants in this study will receive both study medicines. Both study medicines are tablets that are taken by mouth at home twice a day.\n\nParticipants will receive study medicines until their cancer is no longer responding, unacceptable side effects, or 2 years. Participants may continue to receive study therapy beyond 2 years. We will examine the experiences of people receiving the study medicines. This will help us determine if the study medicines are safe and effective.",[357,358,359,360,361,362,363,364,365,366,367,368,369],"Melanoma","Glioma","Thyroid Cancer","Non-Small Cell Lung Cancer","Malignant Neoplasms","Brain Neoplasms","Advanced or Metastatic Solid Tumors","HGG","LGG","Low Grade Glioma","High Grade Glioma","Differentiated Thyroid Cancer","NSCLC (Non-small Cell Lung Cancer)",[371,372,373,374,375,376,377],"solid tumors","BRAF","advanced solid tumors","B-Raf","MAPK","neoplasms","BRAF V600",{"date":38,"type":39},{"date":380,"type":39},"2022-11-30",{"date":382,"type":21},"2029-06-18",{"name":45,"class":46},83,{"id":386,"slug":4,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":54,"minAge":350,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":404},"100466589","NCT05355701","A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.","A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS","This study is seeking participants who meet the following key eligibility criteria:\n\nInclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic solid tumor including primary brain tumor.\n* Qualifying BRAF alteration (V600 or non-V600 Class II\u002FClass III BRAF alteration), in tumor tissue and\u002For blood (ie circulating tumor deoxyribonucleic acid \\[DNA\\], or ctDNA).\n* Disease progressed during\u002Ffollowing last prior treatment and no satisfactory alternative treatment options (Part 1, Part 2 (doublet), and Part 3 (cohorts 2, 3, 6, 7)).\n* Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies\n* Part 3 (Cohort 1) (BRAF V600 mutant melanoma): Prior BRAF V600 inhibitor therapy required, prior MEK inhibitor therapy required, and immune checkpoint inhibitor therapy required.\n* Part 3 (Cohort 4) (BRAF V600E CRC): Minimum of 2 cycles of prior 5-FU based chemotherapy required. No prior BRAF inhibitor\u002FEGFR inhibitor allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n* Part 3 (Cohort 5) (BRAF V600E CRC): No more than 2 cycles of prior 5-FU based chemotherapy allowed. No prior BRAF inhibitor\u002FEGFR inhibitors allowed. Participants with MSI-H\u002FdMMR mCRC should receive prior immune checkpoint inhibitor therapy.\n\nExclusion Criteria:\n\n* Brain metastasis larger than 4 cm\n* Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO; history of retinal degenerative disease.\n* Concurrent neuromuscular disorder associated with elevated creatine kinase (CK).",{"count":392,"type":21},267,[354],"The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines in people with solid tumors.\n\nThis study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called \"BRAF\" and available treatments are no longer effective in controlling their cancer.\n\nAll participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine:\n\n* People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day.\n* People with colorectal cancer may also receive cetuximab or cetuximab and mFOLFOX6 (Chemotherapy regimen). Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV).\n\nParticipants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.",[357,396,359,358,397],"Non-Small-Cell Lung Cancer","Advanced Colorectal Cancer (Part 1)",{"date":38,"type":39},{"date":400,"type":39},"2022-07-05",{"date":402,"type":21},"2029-10-25",{"name":45,"class":46},40,{"id":406,"slug":4,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":54,"minAge":411,"maxAge":328,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":425,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100451276","NCT05156398","Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to \u003C18 Years of Age","Inclusion Criteria:\n\n1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:\n\n   1. 14 or less headache days per month during the 3 month period prior to the Screening Visit\n   2. 6 or more migraine days during the Observation Period\n   3. 14 or less headache days during the Observation Period\n   4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \\>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit\n   5. Ability to verbally distinguish migraine attacks from tension\u002Fcluster or other types of headaches\n   6. Migraine attacks, on average, lasting 4 - 72 hours if untreated\n   7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \\\u003C18 years; subjects must be less than 18 at the time of signing assent \u002F consent.\n\n      3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.\n\nExclusion Criteria:\n\n1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine\n2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.\n3. The subject has a history or diagnosis of complications of migraine\n4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.\n5. The subject has any current psychiatric condition that is uncontrolled and\u002For untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and\u002For mania are excluded.\n6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.\n7. History of major psychiatric disorder.\n8. The subject has a current diagnosis or history of substance abuse\n9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.","6 Years",{"count":413,"type":21},640,[24],"The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \\\u003C18 years with episodic migraine.",[417],"Migraine",[417,419,420,421,422,423,424],"Migraine prevention","Phonophobia","Photophobia","Nausea","Pediatric migraine","Adolescent migraine",{"date":38,"type":39},{"date":427,"type":39},"2022-02-28",{"date":429,"type":21},"2032-11-27",{"name":45,"class":46},91,{"id":433,"slug":4,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":54,"minAge":411,"maxAge":328,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":443,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":445,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":449,"locationsCount":450},"100419547","NCT04743141","Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine","Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to \u003C 18 Years of Age","Inclusion Criteria:\n\n1. History of migraine (with or without aura) for ≥ 6 months before Screening.\n2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.\n3. 1 or more migraine days requiring treatment during the Observation Phase.\n4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.\n5. Ability to distinguish between migraine and other types of headaches.\n6. Weight \\> 15 kg. For EU countries only: Participants 12 to \\\u003C 18 years of age must have a body weight of \\>25kg.\n7. Adequate venous access for blood sampling.\n8. Male and female participants 6 to \\\u003C 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).\n\nExclusion Criteria:\n\n1. History of cluster headache or hemiplegic migraine headache.\n2. Confounding and clinically significant pain syndrome.\n3. Current uncontrolled and\u002For untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and\u002For mania are excluded).\n4. History of suicidal behavior or at risk of self-harm\u002Fharm to others.\n5. History of major psychiatric disorder.\n6. Current diagnosis or history of substance abuse\n7. Reported current use of or tested positive at Screening for drugs of abuse.",{"count":439,"type":21},600,[24],"The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \\\u003C 18 years of age).",[62],[444],"Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent",{"date":38,"type":39},{"date":447,"type":39},"2021-04-28",{"date":43,"type":21},{"name":45,"class":46},126,{"id":452,"slug":4,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":4,"eligibilityCriteria":456,"healthyVolunteers":11,"sex":54,"minAge":411,"maxAge":328,"enrollmentInfo":457,"targetDuration":4,"studyType":22,"phases":459,"briefSummary":460,"conditions":461,"keywords":463,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},"100412337","NCT04649242","Randomized Study in Children and Adolescents With Migraine: Acute Treatment","Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to \u003C 18 Years of Age","Inclusion Criteria:\n\n1. History of migraine (with or without aura) for \\> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and\u002For participant's parent(s)\u002Flegal representative(s).\n2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \\> 3 hours without treatment, and attacks occurring at intervals \\> 24 hours.\n3. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.\n\n   1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \\[biologic or small molecule\\], during the treatment phases.\n   2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.\n   3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.\n4. Verbally distinguish between migraine and other types of headaches.\n5. Participants must have a weight \\> 40 kg at the Screening Visit.\n6. Adequate venous access for blood sampling.\n7. Male and female participants ≥ 6 to \\\u003C 18 years of age (participants must not reach their 18th birthday during the study).\n\nExclusion Criteria:\n\n1. History of cluster headache or hemiplegic migraine headache.\n2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.\n3. Current psychiatric condition that is uncontrolled and\u002For untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and\u002For mania.\n4. History of suicidal behavior or major psychiatric disorder.\n5. Current diagnosis or history of substance abuse; positive drug test at Screening.\n6. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.\n7. Recent or planned surgery, requiring general anesthesia, \\\u003C8 weeks prior to the Screening Visit.\n8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).\n9. Current diagnosis of viral hepatitis or a history of liver disease.\n10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy",{"count":458,"type":21},2100,[24],"The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.",[462],"Pediatric Migraine",[417,464,420,421,422,465,466,467,462],"Acute treatment","Pediatric","Children","Adolescent",{"date":38,"type":39},{"date":470,"type":39},"2021-01-15",{"date":472,"type":21},"2029-01-09",{"name":45,"class":46},246,{"id":476,"slug":4,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":481,"targetDuration":4,"studyType":22,"phases":483,"briefSummary":484,"conditions":485,"keywords":489,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":384},"100321141","NCT03460977","A Study of Mevrometostat for Treatment of Relapsed\u002FRefractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma","A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED\u002FREFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)","Part 1 and Part 2 (Closed for enrollment).\n\nPart 3 Key Inclusion Criteria:\n\n* Histological or cytological diagnosis of castration resistant prostate cancer.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months.\n* Adequate bone marrow, renal, and liver function\n\nPart 3 Key Exclusion Criteria:\n\n* Prior irradiation to \\>25% of the bone marrow.\n* QTcF interval \\>480 msec at screening.\n* Hypertension that cannot be controlled by medications (\\>150\u002F90 mmHg despite optimal medical therapy).\n* Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)\n* Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.\n* Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4\u002F5 inducers or inhibitors\n* Prior enzalutamide within the last 4 weeks\n* DDI SUBSTUDY:\n* history of CHF or evidence of ventricular dysfunction\n* fructose intolerance\n* coadministration of CYP3A4 substrates",{"count":482,"type":21},453,[354],"The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed\u002F Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment.\n\nPart 3, which is open for enrollment is seeking men who:\n\n* have Castration Resistant Prostate Cancer (CRPC) and\n* have previously received treatment for CRPC and have progressed from the last treatment\n\nAll participants in Part 3 of this study will receive mevrometostat and\u002F or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort).\n\nIn the assessment phase:\n\n* participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods.\n* participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and\u002For itraconazole 1 time a day based on a present schedule.\n* participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and\u002For itraconazole 1 time a day based on a present schedule.\n\nAfter completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding.\n\nThe study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.",[486,487,488],"Metastatic Castration Resistant Prostate Cancer (mCRPC)","Small Cell Lung Cancer (SCLC)","Follicular Lymphoma (FL)",[240,490,245,246,243,247,248,249,250,491,492,493,494,495,496,497,498,499],"enhancer of zeste homolog 2","dose escalation","dose expansion","open-label","small cell lung cancer","SCLC","follicular lymphoma","FL","relapsed","refractory",{"date":38,"type":39},{"date":502,"type":39},"2018-04-17",{"date":504,"type":21},"2029-07-07",{"name":45,"class":46},{"id":507,"slug":4,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":22,"phases":514,"briefSummary":515,"conditions":516,"keywords":521,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":536},"100595161","NCT07028853","This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.","A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)","Inclusion Criteria\n\n* Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.\n* Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue\u002Fvisceral disease).\n* Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement).\n* Participants must have ECOG PS 0 or 1.\n\nExclusion Criteria\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Clinically significant cardiovascular disease.\n* Known or suspected brain metastasis or active leptomeningeal disease.\n* Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC.\n* Previous administration with an investigational product (drug or vaccine) within 30 days.\n* Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization.\n* Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization\n* Current use or anticipated need for drugs that are known strong CYP3A4\u002F5 inhibitors and inducers (with exception of enzalutamide as part of this study).\n* Inadequate organ function.\n* Known allergic or hypersensitivity reactions to mevrometostat or its excipients or to enzalutamide or its excipients.",{"count":513,"type":21},1000,[24],"This study will explore whether a combination of the investigational drug mevrometostat (PF-06821497) and enzalutamide will work better than taking enzalutamide alone in participants with mCSPC who are ARPI naïve and have not yet received chemotherapy in the mCSPC setting.",[517,518,519,520],"Metastatic Castration Sensitive Prostate Cancer (mCSPC)","Hormone Sensitive Prostate Cancer","Prostate Cancer","Cancer of the Prostate",[518,522,523,239,240,241,242,524,525,526,527,246,528,247,248,249,250],"Mevrometostat","Metastatic castration sensitive prostate cancer","mCSPC","HSPC","Prostate cancer","castrate sensitive prostate cancer","Phase 3","2026-06-26",{"date":36,"type":39},{"date":532,"type":39},"2025-09-28",{"date":534,"type":21},"2034-12-08",{"name":45,"class":46},341,{"id":538,"slug":4,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":167,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":558},"100644851","NCT07677358","A Study to Learn How the Study Medicine Called Atirmociclib is Handled by the Body in People With Normal Liver Function and Different Levels of Liver Disease","A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL GROUP STUDY TO COMPARE THE PHARMACOKINETICS OF ATIRMOCICLIB IN ADULT PARTICIPANTS WITH VARYING DEGREES OF HEPATIC IMPAIRMENT RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION","Inclusion criteria including but not limited to:\n\n* BMI of 17.5-40 kg\u002Fm2; and a total body weight \\>50 kg (110 lb).\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n* Capable of giving signed informed consent.\n\nNormal hepatic function group only:\n\n\\- Overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and standard 12-lead ECGs.\n\nHepatic impairment groups only:\n\n\\- Stable hepatic impairment meeting the criteria for Child-Pugh Class A, B, or C . Stable hepatic impairment is defined as no clinically significant change in disease status within the last 28 days prior to the screening visit, as documented by the participant's recent medical history.\n\nExclusion criteria including but not limited to:\n\n* Any condition or history of surgery possibly affecting drug absorption.\n* Use of prohibited prior or concomitant medications.\n\nNormal hepatic function group only:\n\n\\- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).\n\nHepatic impairment groups only:\n\n\\- A diagnosis of hepatic dysfunction secondary to any acute ongoing hepatocellular process that is documented by medical history, PE, liver biopsy, hepatic ultrasound, CT scan, or MRI.",{"count":544,"type":21},28,[354],"The purpose of this study to understand how the study medicine atirmociclib behaves in the body and how safe it is for people with different levels of liver health.\n\nThe study is seeking participants who are:\n\n* Aged 18 years or older\n* Have a BMI of 17.5 to 40 kg\u002Fm2, and body weight more than 50 kg.\n* Have normal liver function or have stable mild, moderate, or severe liver disease\n\nParticipants will receive study medicine by mouth. Blood samples will be collected to see how much of the medicine is in the body over time. This will help understand whether liver disease changes how the medicine is handled.\n\nParticipants will be in the study for about 9 weeks. Those with normal liver function will stay in the clinic for about 7 days. People with liver disease will stay for about 9 days. After leaving the clinic, people may be contacted for follow-up. This may be done by phone or through a clinic visit.",[548,549,550],"Hepatic Impairment","Healthy, Hepatic Insufficiency","Healthy Adults","2026-06-24",{"date":36,"type":39},{"date":554,"type":21},"2026-07-09",{"date":556,"type":21},"2027-09-10",{"name":45,"class":46},3,{"id":560,"slug":4,"hasResults":11,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":167,"sex":54,"minAge":55,"maxAge":565,"enrollmentInfo":566,"targetDuration":4,"studyType":22,"phases":568,"briefSummary":569,"conditions":570,"keywords":574,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":81},"100641361","NCT07660731","A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma","A PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, RELATIVE BIOAVAILABILITY, FOOD EFFECT, METABOLISM & EXCRETION, AND DRUG-DRUG INTERACTION POTENTIAL OF PF-08103402 IN HEALTHY ADULTS AND\u002FOR ADULTS WITH MILD TO MODERATE ASTHMA","Key Inclusion criteria (Parts A, B, C, D and F):\n\n1. Are males or females who can no longer have children,\n2. Are 18 to 65 years old,\n3. Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nFor Part A (Optional group or cohort 3: Japanese participants only):\n\n1. A total body weight of more than 45 kg (100 pounds).\n2. Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\nAdults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study.\n\n1\\. Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nKey Exclusion criteria\n\n1. Evidence or history of clinically significant medical conditions.\n2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).\n3. History of alcohol abuse or binge drinking and\u002For any other illicit drug use or dependence within 6 months of Screening.\n4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.\n5. Any history of parasitic infection requiring treatment within 28 days prior to screening.\n6. Positive tuberculosis infection test result.\n7. Part C only: Evidence or history of conditions interfering with the ability to taste.\n8. Part D only: History of irregular bowel movements.\n9. Part E only: Evidence of lung disease(s) other than asthma.\n10. Part E only: Asthma exacerbation within 3 months prior to screening.\n11. Part F only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis or adverse reaction to midazolam or other benzodiazepines.","65 Years",{"count":567,"type":21},139,[354],"The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people.\n\nFor Parts A, B, C, D and F, the study is seeking participants who:\n\n* Are healthy (do not have disease) males or females who can no longer have children,\n* Are 18 to 65 years old,\n* Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight\n\nFor Part A (optional group or cohort 3: Japanese participants only):\n\n* A body weight of more than 45 kilograms (100 pounds).\n* Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\n* Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study.\n* Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nThe study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand:\n\n* how the body processes the study medicine in healthy participants (Parts A and B),\n* how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C),\n* how the study medicine is broken down and leaves the body in healthy participants (Optional Part D),\n* how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E),\n* if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F).\n\nParticipants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E).\n\nDuring this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing.\n\nStudy measurements will be taken by body examination, monitoring side effects, blood and urine tests, heart tests (ECG), vital signs (blood pressure and pulse), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).",[571,550,572,573],"Healthy Volunteer Study","Healthy Participants","Asthma",[575,576,577,578,579,580],"Human","Randomized","Metabolism","Excretion","Drug-Drug Interaction","Food effect",{"date":63,"type":39},{"date":583,"type":39},"2026-06-17",{"date":585,"type":21},"2027-06-18",{"name":45,"class":46},{"id":588,"slug":4,"hasResults":11,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":167,"sex":54,"minAge":593,"maxAge":328,"enrollmentInfo":594,"targetDuration":4,"studyType":22,"phases":596,"briefSummary":597,"conditions":598,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":602,"completionDateStruct":604,"leadSponsor":606,"locationsCount":607},"100641422","NCT07660198","Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents","A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS","Inclusion Criteria:\n\nCohort 1 (Participants ≥15 Months to \\\u003C2 Years of Age) Healthy toddlers and children ≥15 months to \\\u003C2 years of age with documentation of prior receipt of PCV.\n\nCohort 2 (Participants ≥2 Years to \\\u003C5 Years of Age) Healthy toddlers and children ≥2 years to \\\u003C5 years of age with documentation of prior receipt of PCV if applicable.\n\nCohort 3 (Participants ≥5 Years to \\\u003C18 Years of Age) Healthy children ≥5 years to \\\u003C18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.\n\nExclusion Criteria:\n\nAll Cohorts (Participants ≥15 Months to \\\u003C18 Years of Age)\n\nChildren with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial","15 Months",{"count":595,"type":21},1200,[24],"The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).\n\nThis study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae\n\nThis study is seeking participants who:\n\n* Are children aged 15 months to 18 years.\n* May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past.\n\nThe study will be conducted in the United States, Puerto Rico, and other countries.\n\nParticipants will be assigned to 1 of 3 groups based on age:\n\nGroup 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants)\n\nWithin each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC.\n\nEach participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up).\n\nAt the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.",[599],"Pneumococcal Disease","2026-06-23",{"date":551,"type":39},{"date":603,"type":39},"2026-06-15",{"date":605,"type":21},"2027-12-02",{"name":45,"class":46},44,{"id":609,"slug":4,"hasResults":11,"nctId":610,"briefTitle":611,"officialTitle":612,"acronym":613,"eligibilityCriteria":614,"healthyVolunteers":11,"sex":54,"minAge":615,"maxAge":616,"enrollmentInfo":617,"targetDuration":4,"studyType":22,"phases":619,"briefSummary":620,"conditions":621,"keywords":623,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":629,"startDateStruct":630,"completionDateStruct":631,"leadSponsor":633,"locationsCount":7},"100629148","NCT07470879","A Study of How the Medicine Called \"Etrasimod\" Works in Children With the Gut Disease Called Ulcerative Colitis","A PHASE 2 OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE EFFICACY, PHARMACOKINETICS, AND SAFETY OF ETRASIMOD IN PEDIATRIC PARTICIPANTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS","ELEVATE-UCkids","Inclusion criteria:\n\nHave a diagnosis of ulcerative colitis (UC) that is moderately to severely active Participants are permitted to be receiving a therapeutic dose of select UC therapies\n\nExclusion criteria:\n\nSevere extensive colitis Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis","2 Years","11 Years",{"count":618,"type":21},24,[140],"The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to \\\u003C 12 years of age). Participants who will complete the total 52-week treatment period will have the opportunity to continue in a Long-Term Extension (LTE) Period of up to 4 years (5 years after study enrollment).",[622],"Colitis, Ulcerative",[624,625,626,627,628],"ulcerative","colitis","ulcerative colitis","etrasimod","pediatrics",{"date":529,"type":39},{"date":66,"type":39},{"date":632,"type":21},"2034-08-18",{"name":45,"class":46},{"id":635,"slug":4,"hasResults":11,"nctId":636,"briefTitle":637,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":641,"conditions":642,"keywords":644,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":4},"100644801","NCT07673081","Real-World Effectiveness of RSV Vaccines Among Adults Using Target Trial Emulation in Epic Cosmos","Inclusion: Vaccinated Cohort\n\nPatients must meet all the following inclusion criteria to be eligible for inclusion in the vaccinated cohort:\n\nAdults meet the age criteria at the index date. Non-pregnant at the index date. Have at least one clinical encounter recorded in Epic Cosmos database during the 12 months prior to the index date.\n\nHave a documented administration of ABRYSVO® (or AREXVY®，mRESVIA® in the later phase) in Epic Cosmos on or after August 2023.\n\nThe index date for vaccinated individuals will be defined as the date of RSV vaccination.\n\nUnvaccinated Cohort\n\nPatients must meet all the following inclusion criteria to be eligible for inclusion in the unvaccinated cohort:\n\nAdults meet the age criteria at the index date. Non-pregnant at the index date. Have at least one clinical encounter recorded in Epic Cosmos database during the 12 months prior to the index date.\n\nHave no documented receipt of any RSV vaccine in Epic Cosmos on or prior to the trial start date.\n\nThe index date for unvaccinated individuals will be defined as the start date of each sequential trial (e.g., 1st date of each month) in which they met eligibility criteria.\n\nExclusion:\n\nVaccinated Cohort\n\nPatients meeting any of the following criteria will not be included in the vaccinated cohort:\n\nIndividual with receipt of any RSV vaccine in Epic Cosmos prior to the trial start date, as defined above (applicable to all analyses except for the analysis of recipients of multiple doses).\n\nNon-US residents. Unvaccinated Cohort\n\nPatients meeting any of the following criteria will not be included in the unvaccinated cohort:\n\nIndividual with receipt of any RSV vaccine in Epic Cosmos on or prior to the trial start date, as defined above.\n\nNon-US residents. Patients must meet all the inclusion criteria and none of the exclusion criteria to meet eligibility requirements.",{"count":640,"type":21},293334,"Among non-pregnant adults observed in Epic Cosmos since August 2023 who are eligible for RSV vaccination, what is the effectiveness of ABRYSVO® (RSVpreF), compared with unvaccinated individuals, in preventing RSV-related and all-cause acute respiratory illness (ARI), lower respiratory tract disease (LRTD), and other outcomes of interest, within a target trial emulation (TTE) framework",[643],"Respiratory Syncytial Virus (RSV)",[645,646],"RSV, Respiratory Syncytial Virus","Vaccine effectivness","2026-06-22",{"date":63,"type":39},{"date":650,"type":21},"2026-06-20",{"date":652,"type":21},"2026-11-30",{"name":45,"class":46},{"id":655,"slug":4,"hasResults":11,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":4,"eligibilityCriteria":659,"healthyVolunteers":167,"sex":54,"minAge":660,"maxAge":661,"enrollmentInfo":662,"targetDuration":4,"studyType":22,"phases":664,"briefSummary":665,"conditions":666,"keywords":668,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":670,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":675,"locationsCount":676},"100605263","NCT07160244","BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies","A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS","Key Inclusion criteria- Maternal:\n\n* Healthy pregnant women ≤49 years of age who are between 24 0\u002F7 and 36 0\u002F7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.\n* Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.\n* Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.\n* Capable of giving personal signed informed consent.\n* Willing to give informed consent for her infant to participate in the study.\n\nKey Exclusion criteria- Maternal:\n\n* Prepregnancy body mass index (BMI) of \\>40 kg\u002Fm2.\n* Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.\n* Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.\n* History of microbiologically proven invasive disease caused by GBS in the current pregnancy.\n* A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).\n\nKey Inclusion criteria- Infant Participants\n\n\\- Evidence of a signed and dated ICD signed by the parent(s)\u002Flegally authorized representative or legal guardian\n\nKey Exclusion Criteria - Infant Participants:\n\n\\- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.\n\nKey Exclusion Criteria - Infant immunogenicity subset Participants:\n\n\\- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.\n\nRefer to the study contact for further eligibility details","1 Day","49 Years",{"count":663,"type":21},6000,[24],"BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.\n\nThis study is seeking healthy pregnant participants:\n\n* aged 49 or younger who can join.\n* between 24 and 36 weeks of gestation (\"Gestational age\" is a medical term used to describe how far along your pregnancy is)\n* had a fetal ultrasound examination performed with no major fetal abnormalities observed\n* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.\n\nA subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and\u002For pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and\u002For toddler (booster) doses.",[667],"Healthy",[669],"group B streptococcus, maternal immunization, vaccine",{"date":600,"type":39},{"date":672,"type":39},"2025-08-25",{"date":674,"type":21},"2029-03-02",{"name":45,"class":46},202,{"id":678,"slug":4,"hasResults":11,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":682,"eligibilityCriteria":683,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":684,"targetDuration":4,"studyType":22,"phases":686,"briefSummary":687,"conditions":688,"keywords":689,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":692,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":698},"100487126","NCT05623020","A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant","AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA","MagnetisMM-6","Inclusion Criteria:\n\n* Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al., 2014)\n* Measurable disease based on IMWG criteria as defined by at least 1 of the following:\n\n  * Serum M-protein ≥0.5 g\u002FdL (Part 1) and ≥1 g\u002FdL (Part 2);\n  * Urinary M-protein excretion ≥200 mg\u002F24 hours;\n  * Involved FLC ≥10 mg\u002FdL (≥100 mg\u002FL) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Part 1: Participants with relapsed\u002Frefractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age \\\u003C65 years with comorbidities impacting the possibility of transplant.\n* Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:\n\n  * Participants not considered candidates for high-dose chemotherapy and ASCT due to age or\n  * Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT.\n* ECOG performance status ≤2.\n* Not pregnant and willing to use contraception\n* For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.\n\nExclusion Criteria:\n\n* Smoldering Multiple Myeloma.\n* Monoclonal gammopathy of undetermined significance.\n* Waldenströms Macroglobulinemia\n* Plasma cell leukemia.\n* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19\u002FSARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.\n* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0\u002F1 with minimal risk of recurrence per investigator.\n* For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.\n* For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening.\n* Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.\n* Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.",{"count":685,"type":21},1116,[24],"Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma.\n\nThere are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.",[269],[271,286,272,690,691,277,682,284],"Daratumumab","Lenalidomide",{"date":600,"type":39},{"date":694,"type":39},"2022-11-10",{"date":696,"type":21},"2033-10-03",{"name":45,"class":46},121,""]