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 diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (>50%) Grade 3 features are present. - 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. - Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV - 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, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening. - 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. - 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
Birmingham, Alabama 35233
Study Coordinator
205-934-4986
Walnut Creek, California 94598
Study Coordinator
925-692-5603
Miami Beach, Florida 33140
Study Coordinator
305-674-2625
Orlando, Florida 32806
Study Coordinator
321-841-8393
Atlanta, Georgia 30308
Study Coordinator
404-778-1900
Arlington Heights, Illinois 60005
Study Coordinator
847-259-4482
Fort Wayne, Indiana 46845
Study Coordinator
206-266-7701
Indianapolis, Indiana 46237
Study Coordinator
317-528-5000
Covington, Louisiana 70433
Study Coordinator
985-892-2252
Scarborough, Maine 04074
Study Coordinator
207-883-0069
Columbia, Maryland 21044
Study Coordinator
410-964-2212
Omaha, Nebraska 68114
Study Coordinator
402-354-7939
Omaha, Nebraska 68198
Study Coordinator
402-559-2000
Reno, Nevada 89511
Study Coordinator
775-327-4673
Albany, New York 12208-1743
Study Coordinator
518-458-1390
New York, New York 10022
Study Coordinator
347-923-8746
Durham, North Carolina 27710
Study Coordinator
919-681-6900
Cincinnati, Ohio 45219
Study Coordinator
513-584-1000
Tulsa, Oklahoma 74146
Study Coordinator
918-505-3200
Philadelphia, Pennsylvania 19104
Study Coordinator
215-662-4000
Providence, Rhode Island 02905
Study Coordinator
401-274-1122x48181
Germantown, Tennessee 38138
Study Coordinator
901-683-0055
Knoxville, Tennessee 37920
Study Coordinator
865-305-9000
Nashville, Tennessee 37232
Study Coordinator
615-936-4585
Fairfax, Virginia 22031
Study Coordinator
703-280-5390
Norfolk, Virginia 23502
Study Coordinator
757-466-8663
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC