A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMerck Sharp & Dohme LLC
About this trial
Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:
* Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. * Observation, which is watching to see if cancer grows or worsens
The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.
Eligibility criteria
Qualifiers
Has histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies.
Has completed primary debulking surgery or interval debulking surgery.
Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.
Has provided tumor tissue that is not previously irradiated.
Disqualifiers
Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors. mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Has a history of severe eye disease.
Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.
Trial design
Treatments tested in this trial
- Sacituzumab tirumotecan
- Bevacizumab
- Rescue Medications
Treatment groups
900 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov