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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT06843447

Registry updated: 2026-10-19
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Description

Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer. 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 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.

Interventions

  • Raludotatug Deruxtecan (Biological)
    IV infusion on Day 1 of every 3-week cycle.
  • Carboplatin (Drug)
    IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
  • Paclitaxel (Drug)
    IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
  • Bevacizumab (Biological)
    IV infusion on Day 1 of every 3-week cycle.
  • Rescue Medication (Drug)
    Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
  • Pembrolizumab (Biological)
    IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.
  • Gemcitabine (Drug)
    IV injection on days 1 and 8 of each 3-week Cycle
  • Pegylated liposomal doxorubicin (Drug)
    IV injection administered on Day 1 of each 4-week cycle
  • MK-2010 (Drug)
    IV infusion on Day 1 of every 3-week cycle

Eligibility criteria

Inclusion Criteria: * Has pathologically documented diagnosis of high-grade serous or high-grade endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer * Participants in Part 1 cohorts and Part 2 Cohort A-2 Arms 1, 2, and 3, Cohort B-2, and Cohort C-2 Arm 3: Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1 * Participants in Cohort A-1 Arms 2 and 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 must have received no more than 1 prior bevacizumab-containing systemic treatment regimen * Participants in Cohort B-1, Cohort B-2, Cohort C-2 Arm 3, Cohort E-1 and if administering bevacizumab is planned in Cohort D or Cohort A-2 Arms 1, 2, or 3: Is a candidate for bevacizumab treatment * Has provided tumor tissue for biomarker research (all cohorts) * Has an Eastern Cooperative Oncology Group performance status of 0 to 1 * Participants in Cohort C-1, Cohort C-2 Arm 3, Cohort D, and Cohort E-1: 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 poly-ADP ribose polymerase inhibitor (PARPi) in the first-line setting * Participants in Cohort A-2 Arms 1, 2, and 3: Has relapsed disease after 1 prior line 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 C-2 Arms 1 and 2: Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics Stage III or Stage IV epithelial ovarian cancer (high-grade serous or high-grade endometrioid), fallopian tube cancer, or primary peritoneal cancer that is non-homologous recombination deficiency-positive * Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, PARPi first-line maintenance treatment for non- homologous recombination deficiency (HRD)-positive disease is not the preferred option for the participant * Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, bevacizumab treatment for non-HRD-positive disease is not the preferred option for the participant Exclusion Criteria: * Has any of the following within 6 months before allocation/randomization: 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 any history of interstitial lung disease (ILD)/pneumonitis irrespective of prior steroid use, current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening * Has active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

Conditions

Ovarian Cancer Recurrent

Locations

  • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019) — New Haven, Connecticut, United States
  • The University of Louisville, James Graham Brown Cancer Center ( Site 0009) — Louisville, Kentucky, United States
  • TRIALS 365 ( Site 0020) — Shreveport, Louisiana, United States
  • Dana-Farber Cancer Institute ( Site 0015) — Boston, Massachusetts, United States
  • Memorial Sloan Kettering Cancer Center ( Site 0003) — New York, New York, United States
  • OU Health University of Oklahoma Medical Center ( Site 7000) — Oklahoma City, Oklahoma, United States
  • Texas Oncology - DFW ( Site 8000) — Fort Worth, Texas, 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
  • Centre Hospitalier de l'Université de Montréal ( Site 0102) — Montreal, Quebec, Canada
  • McGill University Health Centre ( Site 0100) — Montreal, Quebec, Canada
  • Rambam Health Care Campus ( Site 0202) — Haifa, Israel
  • Shaare Zedek Medical Center ( Site 0201) — Jerusalem, Israel
  • Rabin Medical Center ( Site 0203) — Petah Tikva, Israel
  • Sheba Medical Center ( Site 0200) — Ramat Gan, Israel
  • National Cancer Center ( Site 2004) — Goyang-si, Kyonggi-do, South Korea
  • Asan Medical Center ( Site 2003) — Seoul, South Korea
  • Institut Català d'Oncologia - L'Hospitalet ( Site 0302) — L'Hospitalet de Llobregat, Barcelona, Spain
  • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307) — Majadhonda, Madrid, Spain
  • Clinica Universidad de Navarra ( Site 0301) — Madrid, Madrid, Comunidad de, Spain
  • Hospital General Universitario de Valencia ( Site 0305) — Valencia, Valenciana, Comunitat, 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
  • Hospital Universitario Virgen de la Victoria ( Site 0306) — Málaga, Spain
  • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802) — Basel, Canton of Basel-City, Switzerland
  • CHUV (centre hospitalier universitaire vaudois) ( Site 0800) — Lausanne, Canton of Vaud, Switzerland
  • HOCH Health Ostschweiz ( Site 0801) — Sankt Gallen, Switzerland
  • University Hospitals Sussex NHS Foundation Trust ( Site 0404) — Brighton, East Sussex, United Kingdom
  • 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
  • Guy s & St Thomas NHS Foundation Trust ( Site 0400) — London, London, City of, United Kingdom
  • The Christie NHS Foundation Trust ( Site 0405) — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record