A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
Purpose
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.
Conditions
- Ovarian Neoplasms
- Ovarian Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
include but are not limited to the following: - 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. - If human immunodeficiency virus (HIV) infected, has well-controlled HIV on antiretroviral therapy. - Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive. - Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection. The main
Exclusion Criteria
include but are not limited to the following: - 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. - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease. - Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, or has current pneumonitis/ILD. - Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria. - Had a live or live-attenuated vaccine within 30 days of randomization. - Has a known additional malignancy that is progressing or required active treatment within the past 3 years. - Has active infection requiring systemic therapy. - Has concurrent and active HBV and HCV infections. - Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease. - Has not recovered from major surgery or has ongoing surgical complications. - Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory. - Has active or ongoing stomatitis of any grade.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Sac-TMT +/- Bevacizumab |
Participants will receive sac-TMT on days 1, 15, and 29 (q2W) of every 6-week cycle, until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation. Participants receive optional bevacizumab at investigator's discretion on Days 1 and 22 (q3w) of every 6-week cycle, for up to 22 courses. |
|
|
Active Comparator Standard of Care |
Participants will either receive bevacizumab q3w of every 6-week cycle for up to 22 courses until disease progression, prohibitive toxicity, or other protocol-defined reason for discontinuation of study intervention, or will be observed only and actively followed if not receiving bevacizumab. |
|
Recruiting Locations
Miami Beach, Florida 33140
Study Coordinator
305-674-2625
Covington, Louisiana 70433
Study Coordinator
985-892-2252
Omaha, Nebraska 68114
Study Coordinator
402-354-7939
Tulsa, Oklahoma 74146
Study Coordinator
918-505-3200
More Details
- NCT ID
- NCT07318558
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC