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RECRUITING
NCT06843447
PHASE1/PHASE2

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Interventions

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.

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