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RecruitingInterventionalPhase 3

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)

NCT ID: NCT07318558Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-06-12

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.

Arms & 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.

Outcome measures

Primary

  • Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD.

    Time frame: Up to approximately 49 months

Secondary

  • Overall Survival (OS)

    Time frame: Up to approximately 78 months

  • Progression-Free Survival 2 (PFS2)

    Time frame: Up to approximately 78 months

  • Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 78 months

  • Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 78 months

  • Change From Baseline in Global Health Status/Quality of Life (GHS/QoL) Combined Score (Items 29 and 30) Using the European Organisation for Research and Treatment of Cancer QoL Questionnaire-Core 30 (EORTC QLQ-C30)

    Time frame: Baseline, and at designated time points up to approximately 78 months

  • Change From Baseline in Physical Functioning Combined Score (Items 1 to 5) Using EORTC QLQ-C30

    Time frame: Baseline, and at designated time points up to approximately 78 months

  • Change From Baseline in Role Functioning Combined Score (Items 6 and 7) Using EORTC QLQ-C30

    Time frame: Baseline, and at designated time points up to approximately 78 months

  • Change From Baseline in Abdominal/Gastrointestinal (GI) Symptoms Combined Score Using the EORTC QLQ-Ovarian Cancer Module 28 (OV28)

    Time frame: Baseline, and at designated time points up to approximately 78 months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (9)

Mount Sinai Cancer Center ( Site 0029)

Miami Beach, Florida, 33140

Recruiting
Study Coordinator · Contact

Orlando Health Winnie Palmer Hospital for Women and Babies ( Site 0085)

Orlando, Florida, 32806

Recruiting
Study Coordinator · Contact

Winship Cancer Institute of Emory University ( Site 0037)

Atlanta, Georgia, 30308

Recruiting
Study Coordinator · Contact

Parkview Research Center at Parkview Regional Medical Center ( Site 0055)

Fort Wayne, Indiana, 46845

Recruiting
Study Coordinator · Contact

Women's Cancer Care ( Site 0018)

Covington, Louisiana, 70433

Recruiting
Study Coordinator · Contact

Nebraska Methodist Hospital ( Site 0004)

Omaha, Nebraska, 68114

Recruiting
Study Coordinator · Contact

University Of Nebraska Medical Center ( Site 0035)

Omaha, Nebraska, 68198

Recruiting
Study Coordinator · Contact

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

Tulsa, Oklahoma, 74146

Recruiting
Study Coordinator · Contact

West Cancer Center and Research Institute ( Site 0013)

Germantown, Tennessee, 38138

Recruiting
Study Coordinator · Contact
A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) | Cancerify