The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).
Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).
Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.
Adequate renal and hepatic function.
Adequate hematologic parameters without transfusional support.
Females who are pregnant or lactating.
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
Has an active second malignancy.
Has known active Hepatitis B or Hepatitis C.
Parallel
Sacituzumab Govitecan-hziy
DrugAdministered intravenously.
Pembrolizumab
DrugAdministered per package insert
Cisplatin
DrugAdministered per package insert
Avelumab
DrugAdministered per package insert
Zimberelimab
DrugAdministered intravenously
Carboplatin
DrugAdministered per package insert
Gemcitabine
DrugAdministered per package insert
Domvanalimab
DrugAdministered intravenously
Enfortumab Vedotin
DrugAdministered intravenously
16
Treatment groupsSee each treatment group below.
Overall Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6)
ORR will be defined as the rate of the best overall response as Complete Response (CR) or Partial Response (PR) and based on central review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
Progression free survival (PFS) Based on Central Review by RECIST 1.1 criteria (Cohort 5)
PFS will be defined as the time from first dose until objective tumor progression, as assessed based on central review, or death, whichever comes first.
ORR Based on Investigator Review by RECIST 1.1 Criteria (Cohort 7)
ORR will be defined as the rate of the best overall response as Complete Response (CR) or Partial Response (PR) and based on investigator review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) criteria.
Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohort 7)
Overall Response Rate (ORR)
ORR will be defined as the rate of the best overall response as CR or PR and based on investigator review by RECIST 1.1 criteria for cohorts 3, 4, 6, and 7. ORR will also be evaluated based on investigator review by Modified RECIST 1.1 for Immune-Based Therapeutics (iRECIST 1.1) for Cohorts 3, 4, 6, and 7.
Duration of Response (DOR)
DOR will be calculated from the date of the first evaluation showing documented response, PR, or CR, to the date of the first disease progression or death and based on central and investigator review by RECIST 1.1 criteria for all cohorts. DOR will also be evaluated based on investigator review by iRECIST 1.1 for Cohorts 3, 4, 6, and 7.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose (Cohorts 1 through 4) or randomization date (Cohorts 5 through 7) until objective tumor progression,or death, whichever comes first and based on central and investigator review by RECIST 1.1 criteria for all cohorts. PFS will also be evaluated based on investigator review by iRECIST 1.1 for Cohorts 3, 4, 6, and 7.
Overall Survival (OS)
OS will be measured from the date of first dose (Cohorts 1 through 4) or randomization date (Cohorts 5 through 7) to death from any cause.
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Gilead Sciences
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborator
