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
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.
Description
This study has 2 parts: Part 1 is a dose escalation phase of R-DXd. Part 2 is the efficacy expansion phase and will use the Recommended Phase 2 Dose (RP2D) of R-DXd determined in Part 1.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
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
- Memorial Sloan Kettering Cancer Center ( Site 0003)New York, New York
- Houston Methodist Hospital ( Site 0010)Houston, Texas
- START Mountain Region ( Site 0008)West Valley City, Utah
- University of Virginia Health System ( Site 0011)Charlottesville, Virginia
- Rambam Health Care Campus ( Site 0202)Haifa