NCT06843447PHASE1, PHASE2RECRUITING

A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)

A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy

Sponsor: Merck Sharp & Dohme LLC + Daiichi Sankyo

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Ovarian Cancer Recurrent

Interventions

Raludotatug Deruxtecan, Carboplatin, Paclitaxel, Bevacizumab

Enrollment

460 participants

Primary completion

Mar 2029

Study completion

Mar 2029

First posted

Feb 2025

Last updated

May 2026

Primary Endpoints (CT.gov)

Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)

Time frame: Up to 21 days

Part 1: Number of Participants with One or More Adverse Events (AEs)

Time frame: Up to approximately 3 years

Part 1: Number of Participants who Discontinue Study Intervention Due to an AE

Time frame: Up to approximately 3 years

Part 2: Objective Response Rate (ORR)

Time frame: Up to approximately 3 years

Secondary Endpoints

Part 1: Objective Response Rate (ORR)

Part 2: Duration of Response (DOR)

Part 2: Progression-free Survival (PFS)

Eligibility Criteria

Inclusion Criteria: * Has pathologically documented diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer * Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1 * Participants in Cohort A-1 Arms 2 and 3: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease) * Participants in Cohort B-1 and Cohort B-2: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression \<6 months (\<180 days) after the last dose of platinum-based therapy (ie, platinum-resistant disease). Participants must have received no more than 1 prior bevacizumab-containing systemic treatment regimen * Participants in Cohort B-1 and Cohort B-2: Is a candidate for bevacizumab treatment * Has provided tumor tissue from a core or excisional biopsy of a…

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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