NCT06824467PHASE3RECRUITING

A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)

Sponsor: Merck Sharp & Dohme LLC + European Network of Gynaecological Oncological Trial Groups (ENGOT), GOG Foundation

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Interventions

Sacituzumab tirumotecan, Bevacizumab, H1 receptor antagonist, H2 receptor antagonist

Enrollment

770 participants

Primary completion

Apr 2029

Study completion

Nov 2032

First posted

Feb 2025

Last updated

May 2026

Primary Endpoints (CT.gov)

Part 1: Number of participants with one or more adverse events (AEs)

Time frame: Up to 6 weeks

Part 1: Number of participants who discontinue study intervention due to an AE

Time frame: Up to 6 weeks

Part 2: Progression-free Survival (PFS)

Time frame: Up to approximately 4 years

Secondary Endpoints

Part 2: Overall Survival (OS)

Part 2: Number of participants with one or more AEs

Part 2: Number of participants who discontinue study intervention due to an AE

Eligibility Criteria

Inclusion Criteria: * Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies * Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC) * Has platinum-sensitive epithelial OC * Has provided tissue of a tumor lesion that was not previously irradiated * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy * Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2) * Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at…

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✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov