NCT06843447

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. 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 relapsed 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.

Detailed description

This study has 2 parts: Part 1 is a dose escalation phase of R-DXd. Part 2 is the efficacy expansion phase and will use the Recommended Phase 2 Dose (RP2D) of R-DXd determined in Part 1.

Conditions

• Ovarian Cancer Recurrent

Interventions

Type	Name	Description
BIOLOGICAL	Raludotatug Deruxtecan	IV infusion on Day 1 of every 3-week cycle.
DRUG	Carboplatin	IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
DRUG	Paclitaxel	IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
BIOLOGICAL	Bevacizumab	IV infusion on Day 1 of every 3-week cycle.
DRUG	Rescue Medication	Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
BIOLOGICAL	Pembrolizumab	IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.

Timeline

• Start date: 2025-04-15
• Primary completion: 2029-03-27
• Completion: 2029-03-27
• First posted: 2025-02-25
• Last updated: 2026-03-27

Locations

16 sites across 4 countries: United States, Israel, Spain, United Kingdom

Regulatory

• FDA-regulated drug study