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

NCT06843447 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Ovarian Cancer Recurrent

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.

DRUG

Gemcitabine

IV injection on days 1 and 8 of each 3-week Cycle

DRUG

Pegylated liposomal doxorubicin

IV injection administered on Day 1 of each 4-week cycle

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2029-03-27
Completion
2029-03-27
FDA Drug
Yes

Countries

  • United States
  • Israel
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06843447 on ClinicalTrials.gov