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
Merck Sharp & Dohme LLC
280 participants
Apr 15, 2025
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
Inclusion Criteria11
- 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 status of 0 to 1 assessed within 7 days before allocation
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy
- Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation
- Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Participants in Cohort C-1 and Cohort D: Has relapsed disease after 1 prior line of therapy, radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease) and progressed during prior treatment with PARPi in the first-line setting
Exclusion Criteria13
- Has any of the following within 6 months before allocation: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event
- Has uncontrolled or significant cardiovascular disease
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement, or prior pneumonectomy
- Has ≥Grade 2 peripheral neuropathy
- Has received prior treatment with cadherin-6-targeted agents
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before allocation
- Has received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids
- Receives chronic steroid treatment
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active CNS metastases and/or carcinomatous meningitis
- Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
- Has active infection requiring systemic therapy
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Interventions
IV infusion on Day 1 of every 3-week cycle.
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
IV infusion on Day 1 of every 3-week cycle.
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06843447