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A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2025-04-15
Completion Date
2029-03-27
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Carboplatin
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Paclitaxel
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Bevacizumab
IV infusion on Day 1 of every 3-week cycle.
Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Pembrolizumab
IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.
Locations (16)
The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
Louisville, Kentucky, United States
Memorial Sloan Kettering Cancer Center ( Site 0003)
New York, New York, United States
Houston Methodist Hospital ( Site 0010)
Houston, Texas, United States
START Mountain Region ( Site 0008)
West Valley City, Utah, United States
University of Virginia Health System ( Site 0011)
Charlottesville, Virginia, United States
Rambam Health Care Campus ( Site 0202)
Haifa, Israel
Shaare Zedek Medical Center ( Site 0201)
Jerusalem, Israel
Sheba Medical Center ( Site 0200)
Ramat Gan, Israel
Institut Català d'Oncologia - L'Hospitalet ( Site 0302)
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra ( Site 0301)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)
Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)
Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 0304)
Madrid, Spain
Royal Marsden Hospital ( Site 0402)
Fulham, England, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 0403)
Sutton, England, United Kingdom
Barts Health NHS Trust ( Site 0401)
London, London, City of, United Kingdom