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Recruiting Phase 1, Phase 2 NCT06843447

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

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Trial Parameters

Condition Ovarian Cancer Recurrent
Sponsor Merck Sharp & Dohme LLC
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 280
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2025-04-15
Completion 2029-03-27
Interventions
Raludotatug DeruxtecanCarboplatinPaclitaxel

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Brief 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 Criteria

Inclusion Criteria: * Has pathologically documented diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer * Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1 * Participants in Cohort A-1 Arm 2 and Arm 3: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease). * Participants in Cohort B-1 and Cohort B-2: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression \<6 months (\<180 days) after the last dose of platinum-based therapy (ie, platinum-resistant disease). * Participants in Cohort B-1 and Cohort B-2: Is a candidate for bevacizumab treatment * Has provided tumor tissue from a core or excisional biopsy of a tumor lesion not previously irradiated * Has an Eastern Cooperative Oncology Group performance stat

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