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

StatusRecruiting
PhasePhase 1/2
Started2025-04-15
View on ClinicalTrials.gov ↗
Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes. Standard treatment (usual treatment) for people with high-grade serous ovarian cancer may include: * Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing * Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.

Amendment history 8 changes detected by DataLookout

2026-09-03
Primary endpoint(s) modified
WasPart 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), Part 1: Number of Participants who Discontinue Study Intervention Due to an AE, Part 1: Number of Participants with One or More Adverse Events (AEs), Part 2: Objective Response Rate (ORR)
NowPart 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), Part 1: Number of Participants who Discontinue Study Intervention Due to an AE, Part 1: Number of Participants with One or More Adverse Events (AEs), Part 2: Objective Response Rate (ORR), Part 2: Progression Free Survival (PFS) - Cohort C-2 Arm 1 and Arm 2
2026-09-03
Enrollment increased: 460 → 605 participants
2026-09-03
Trial arms changed: 10 → 14
2026-09-03
Completion pushed: 2029-03-27 → 2031-02-07
2026-09-03
Interventions modified
2026-05-27
Trial sites expanded: 17 → 20 locations
2026-05-14
Enrollment increased: 280 → 460 participants
2026-05-14
Trial arms changed: 7 → 10
Trial Details
NCT Number NCT06843447
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Daiichi Sankyo
Conditions Ovarian Cancer Recurrent
Enrollment 605 participants
Start Date 2025-04-15
Primary Completion 2029-03-27 (estimated)
Study Completion 2031-02-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-02