Sac-TMT maintenance for people with non-HRD advanced ovarian cancer
A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)
This trial sees if sacituzumab tirumotecan (sac‑TMT), given with or without bevacizumab, can keep cancer from getting worse after surgery and first‑line platinum chemotherapy in people with non‑HRD advanced ovarian cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | chemotherapy, Bevacizumab, sacituzumab |
| Locations | 41 sites (Miami Beach, Florida and 40 other locations) |
| Trial ID | NCT07318558 on ClinicalTrials.gov |
What this trial studies
This phase 3 trial enrolls people with epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who have completed primary or interval debulking surgery and first‑line platinum‑based chemotherapy with at least stable disease. Eligible participants provide tumor tissue and are assigned to receive sac‑TMT maintenance with or without bevacizumab or to standard care (bevacizumab maintenance or observation) per protocol. The main outcome is how long participants live without their cancer getting worse (progression‑free survival), along with safety monitoring. The trial is sponsored by Merck and is conducted at multiple U.S. cancer centers.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who are non‑HRD positive, have completed primary or interval debulking surgery and first‑line platinum chemotherapy with at least stable disease, and can provide tumor tissue and attend participating U.S. sites.
Not a fit: People with nonepithelial tumors, certain low‑grade histologies (for example low‑grade serous or low‑grade endometrioid tumors), those who have not completed standard surgery or first‑line platinum chemotherapy, or who meet other exclusion criteria are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, this approach could extend the time without disease progression and offer a new maintenance option for people with non‑HRD advanced ovarian cancer.
How similar studies have performed: Antibody–drug conjugates and bevacizumab have shown activity in ovarian and other cancers, but sac‑TMT as maintenance specifically for non‑HRD advanced ovarian cancer is a newer approach without established phase 3 results to date.
Eligibility criteria
Show full inclusion / exclusion criteria
The main 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.
Where this trial is running
Miami Beach, Florida and 40 other locations
- Mount Sinai Cancer Center ( Site 0029) — Miami Beach, Florida, United States (Recruiting)
- Parkview Research Center at Parkview Regional Medical Center ( Site 0055) — Fort Wayne, Indiana, United States (Recruiting)
- Women's Cancer Care ( Site 0018) — Covington, Louisiana, United States (Recruiting)
- Nebraska Methodist Hospital ( Site 0004) — Omaha, Nebraska, United States (Recruiting)
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007) — Tulsa, Oklahoma, United States (Recruiting)
- West Cancer Center and Research Institute ( Site 0013) — Germantown, Tennessee, United States (Recruiting)
- Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901) — Mar del Plata, Buenos Aires, Argentina (Recruiting)
- Sanatorio Parque - Oncología ( Site 2911) — Rosario, Santa Fe Province, Argentina (Recruiting)
- Instituto de Oncologia de Rosario ( Site 2909) — Rosario, Santa Fe Province, Argentina (Recruiting)
- Gallipoli Medical Research Ltd ( Site 0204) — Brisbane, Queensland, Australia (Recruiting)
- Epworth Freemasons ( Site 0207) — East Melbourne, Victoria, Australia (Recruiting)
- Aarhus Universitetshospital, Skejby ( Site 0903) — Aarhus, North Denmark, Denmark (Recruiting)
- Kuopion Yliopistollinen Sairaala ( Site 1004) — Kuopio, Northern Savonia, Finland (Recruiting)
- Tampereen yliopistollinen sairaala ( Site 1002) — Tampere, Pirkanmaa, Finland (Recruiting)
- Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1001) — Turku, Southwest Finland, Finland (Recruiting)
- Rambam Health Care Campus ( Site 1422) — Haifa, Israel (Recruiting)
- Edith Wolfson Medical Center ( Site 1423) — Holon, Israel (Recruiting)
- Gunma Prefectural Cancer Center ( Site 1605) — Ōta, Gunma, Japan (Recruiting)
- Hokkaido University Hospital ( Site 1609) — Sapporo, Hokkaido, Japan (Recruiting)
- Hyogo Cancer Center ( Site 1620) — Akashi, Hyōgo, Japan (Recruiting)
- Iwate Medical University Hospital ( Site 1610) — Shiwa-gun, Iwate, Japan (Recruiting)
- Saitama Medical University International Medical Center ( Site 1607) — Hidaka, Saitama, Japan (Recruiting)
- Cancer Institute Hospital of JFCR ( Site 1614) — Koto, Tokyo, Japan (Recruiting)
- Kagoshima City Hospital ( Site 1613) — Kagoshima, Japan (Recruiting)
- Niigata Cancer Center Hospital ( Site 1608) — Niigata, Japan (Recruiting)
- Stavanger Universitetssjukehus ( Site 2002) — Stavanger, Rogaland, Norway (Recruiting)
- Oslo University Hospital ( Site 2001) — Oslo, Norway (Recruiting)
- Severance Hospital ( Site 2302) — Seodaemun-Gu, Seoul, South Korea (Recruiting)
- Keimyung University Dongsan Hospital ( Site 2304) — Daegu, Taegu-Kwangyokshi, South Korea (Recruiting)
- Seoul National University Hospital ( Site 2301) — Seoul, South Korea (Recruiting)
- Asan Medical Center ( Site 2305) — Seoul, South Korea (Recruiting)
- Samsung Medical Center ( Site 2303) — Seoul, South Korea (Recruiting)
- Inselspital Bern ( Site 3504) — Bern, Canton of Bern, Switzerland (Recruiting)
- Ospedale Regionale Bellinzona e Valli ( Site 3501) — Bellinzona, Canton Ticino, Switzerland (Recruiting)
- Kantonsspital Graubünden ( Site 3503) — Chur, Kanton Graubünden, Switzerland (Recruiting)
- Hôpitaux Universitaires de Genève (HUG) ( Site 3502) — Geneva, Switzerland (Recruiting)
- Taichung Veterans General Hospital ( Site 2603) — Taichung, Taiwan (Recruiting)
- National Cheng Kung University Hospital ( Site 2602) — Tainan, Taiwan (Recruiting)
- National Taiwan University Hospital ( Site 2601) — Taipei, Taiwan (Recruiting)
- Mackay Memorial Hospital ( Site 2604) — Taipei, Taiwan (Recruiting)
- Linkou Chang Gung Memorial Hospital ( Site 2605) — Taoyuan, Taiwan (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.