RecruitingPhase 1Phase 2NCT06843447

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

Enrollment

280 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called raludotatug deruxtecan in women with ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, to see how well it works either alone or combined with other treatments. **You may be eligible if...** - You have been diagnosed with high-grade serous ovarian, primary peritoneal, or fallopian tube cancer - Your cancer is measurable on scans - You have had 1 to 3 prior rounds of treatment, or your cancer came back after platinum-based chemotherapy **You may NOT be eligible if...** - Your cancer has certain genetic mutations or characteristics that make you ineligible for specific study arms - You have severe lung disease or other major organ problems - You have had prior treatment with specific antibody-drug therapies targeting the same protein - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALRaludotatug Deruxtecan

IV infusion on Day 1 of every 3-week cycle.

DRUGCarboplatin

IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.

DRUGPaclitaxel

IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.

BIOLOGICALBevacizumab

IV infusion on Day 1 of every 3-week cycle.

DRUGRescue Medication

Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.

BIOLOGICALPembrolizumab

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06843447


Related Trials