RecruitingPhase 3NCT07318558

A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)

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)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

900 participants

Start Date

Feb 16, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a drug called Sac-TMT (sacituzumab tirumotecan) as a maintenance therapy after first-line chemotherapy in people with advanced ovarian, fallopian tube, or peritoneal cancer that is not HRD-positive (meaning a specific DNA repair defect is not present). **You may be eligible if...** - You have confirmed advanced epithelial ovarian, primary peritoneal, or fallopian tube cancer (certain specific subtypes) - You have completed primary or interval surgery to remove the tumor - You have completed first-line platinum-based chemotherapy with a stable, partial, or complete response - You can provide a tumor tissue sample (not previously irradiated) - If you have HIV, it must be well-controlled on medication; hepatitis B/C must also be managed **You may NOT be eligible if...** - Your tumor is a non-epithelial cancer, low-grade serous, mucinous, borderline, or undifferentiated type - You have active brain metastases - You have a history of severe eye disease or active inflammatory bowel disease - You have uncontrolled cardiovascular or cerebrovascular disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab tirumotecan

Administered via intravenous (IV) infusion at a dose of 4mg/kg

DRUGBevacizumab

Administered via IV infusion at a dose of 15mg/kg

DRUGRescue Medications

Participants must receive prophylactic steroid mouthwash (dexamethasone or equivalent). It is recommended that participants receive the following rescue medications prior to sac-TMT infusion, per approved product label: histamine-1 receptor antagonist, histamine-2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent.


Locations(28)

Mount Sinai Cancer Center ( Site 0029)

Miami Beach, Florida, United States

Women's Cancer Care ( Site 0018)

Covington, Louisiana, United States

Nebraska Methodist Hospital ( Site 0004)

Omaha, Nebraska, United States

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0007)

Tulsa, Oklahoma, United States

Sanatorio Parque - Oncología ( Site 2911)

Rosario, Santa Fe Province, Argentina

Gallipoli Medical Research Ltd ( Site 0204)

Brisbane, Queensland, Australia

Epworth Freemasons ( Site 0207)

East Melbourne, Victoria, Australia

Rambam Health Care Campus ( Site 1422)

Haifa, Israel

Edith Wolfson Medical Center ( Site 1423)

Holon, Israel

Hokkaido University Hospital ( Site 1609)

Sapporo, Hokkaido, Japan

Hyogo Cancer Center ( Site 1620)

Akashi, Hyōgo, Japan

Iwate Medical University Hospital ( Site 1610)

Shiwa-gun, Iwate, Japan

Saitama Medical University International Medical Center ( Site 1607)

Hidaka, Saitama, Japan

Cancer Institute Hospital of JFCR ( Site 1614)

Koto, Tokyo, Japan

Kagoshima City Hospital ( Site 1613)

Kagoshima, Japan

Niigata Cancer Center Hospital ( Site 1608)

Niigata, Japan

Severance Hospital ( Site 2302)

Seodaemun-Gu, Seoul, South Korea

Keimyung University Dongsan Hospital ( Site 2304)

Daegu, Taegu-Kwangyokshi, South Korea

Seoul National University Hospital ( Site 2301)

Seoul, South Korea

Asan Medical Center ( Site 2305)

Seoul, South Korea

Samsung Medical Center ( Site 2303)

Seoul, South Korea

Inselspital Bern ( Site 3504)

Bern, Canton of Bern, Switzerland

Ospedale Regionale Bellinzona e Valli ( Site 3501)

Bellinzona, Canton Ticino, Switzerland

Kantonsspital Graubünden ( Site 3503)

Chur, Kanton Graubünden, Switzerland

Hôpitaux Universitaires de Genève (HUG) ( Site 3502)

Geneva, Switzerland

Taichung Veterans General Hospital ( Site 2603)

Taichung, Taiwan

National Cheng Kung University Hospital ( Site 2602)

Tainan, Taiwan

Linkou Chang Gung Memorial Hospital ( Site 2605)

Taoyuan, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07318558


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