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

September 8, 2026 updated by: Merck Sharp & Dohme LLC

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 Advanced High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (REJOICE-Ovarian02)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study has 2 parts: Part 1 is a dose escalation phase of R-DXd. Part 2 is the expansion phase and will use the Recommended Phase 2 Dose (RP2D) of R-DXd determined in Part 1.

Study Type

Interventional

Enrollment (Estimated)

605

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0100)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-934-1934x31975
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 514-890-8000
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-4-7776234
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: +972-(0)2-6555424
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 0203)
        • Contact:
          • Study Coordinator
          • Phone Number: +97239378076
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 0200)
        • Contact:
          • Study Coordinator
          • Phone Number: 972-3-5304498
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)
        • Contact:
          • Study Coordinator
          • Phone Number: +349325434528607
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913908626
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: 34915504800 x2805
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +34951032508
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Institut Català d'Oncologia - L'Hospitalet ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932607744
    • Madrid
      • Majadhonda, Madrid, Spain, 28222
        • Recruiting
        • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 911917358
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +349135319207513
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 963187527
  • Switzerland
      • Sankt Gallen, Switzerland, 9007
        • Recruiting
        • HOCH Health Ostschweiz ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: +41714941111
    • Canton of Basel-City
      • Basel, Canton of Basel-City, Switzerland, 4031
        • Recruiting
        • University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: +41613284214
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Switzerland, 1011
        • Recruiting
        • CHUV (centre hospitalier universitaire vaudois) ( Site 0800)
        • Contact:
          • Study Coordinator
          • Phone Number: +41795567362
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: +441619187689
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 1ES
        • Recruiting
        • University Hospitals Sussex NHS Foundation Trust ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 01273 696 955
    • England
      • Fulham, England, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +442078118084
      • Sutton, England, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden NHS Foundation Trust. ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: +442078118084
    • London, City of
      • London, London, City of, United Kingdom, E1 1RD
        • Recruiting
        • Barts Health NHS Trust ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 7377 7000
      • London, London, City of, United Kingdom, SE1 3SS
        • Recruiting
        • Guy s & St Thomas NHS Foundation Trust ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 020 7188 7188
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-785-2404
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
        • Contact:
          • Study Coordinator
          • Phone Number: 502-562-3429
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • TRIALS 365 ( Site 0020)
        • Contact:
          • Study Coordinator
          • Phone Number: 318-408-1198
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute ( Site 0015)
        • Contact:
          • Study Coordinator
          • Phone Number: 877-338-7425
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-639-2000
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health University of Oklahoma Medical Center ( Site 7000)
        • Contact:
          • Study Coordinator
          • Phone Number: 405-271-1112
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Oncology - DFW ( Site 8000)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-329-7430
      • Houston, Texas, United States, 77030
        • Completed
        • Houston Methodist Hospital ( Site 0010)
    • Utah
      • West Valley City, Utah, United States, 84119
        • Recruiting
        • START Mountain Region ( Site 0008)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-907-4750
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System ( Site 0011)
        • Contact:
          • Study Coordinator
          • Phone Number: 434-924-9333

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1)
Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan (R-DXd) in combination with carboplatin at Dose 1. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
Drug: Carboplatin
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Drug: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Experimental: Cohort A-1 Arm 2 (R-DXd + Paclitaxel)
Participants receive escalating doses of IV R-DXd in combination with paclitaxel. Participants can receive up to a maximum of six 3-week cycles of paclitaxel (approximately 4 months) and will receive R-DXd until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
Drug: Paclitaxel
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Drug: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Experimental: Cohort A-1 Arm 3 (R-DXd + Carboplatin Dose 2)
Participants receive escalating doses of intravenous (IV) R-DXd in combination with carboplatin at Dose 2. Participants can receive up to a maximum of six 3-week cycles of carboplatin (approximately 4 months) and will receive R-DXd until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
Drug: Carboplatin
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Drug: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Experimental: Cohort B-1 (R-DXd + Bevacizumab)
Participants receive escalating doses of IV R-DXd in combination with bevacizumab until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
Biological: Bevacizumab
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • Includes, based on sourcing:
  • - Avastin®
  • - Alymsys®
  • - MVASI®
  • - Oyavas®
  • - Zirabev®
  • - Vegzelma®
  • - Aybintio®
  • - Breztri®
Drug: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Experimental: Cohort B-2 (R-DXd RP2D + Bevacizumab)
Participants with platinum-resistant recurrent ovarian cancer (PRROC) receive recommended Phase 2 dose (RP2D) of IV R-DXd in combination with bevacizumab until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
Biological: Bevacizumab
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • Includes, based on sourcing:
  • - Avastin®
  • - Alymsys®
  • - MVASI®
  • - Oyavas®
  • - Zirabev®
  • - Vegzelma®
  • - Aybintio®
  • - Breztri®
Drug: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Experimental: Cohort C-1 (R-DXd + Pembrolizumab)
Participants receive escalating doses of IV R-DXd in combination with pembrolizumab. Participants can receive up to a maximum of thirty-five 3-week cycles of pembrolizumab (approximately 2 years) and will receive R-DXd until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
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.
Experimental: Cohort A-2 Arm 1 (R-DXd RP2D + Carboplatin +/- Bevacizumab)
Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of carboplatin with or without bevacizumab, until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
Drug: Carboplatin
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.
Other Names:
  • Includes, based on sourcing:
  • - Avastin®
  • - Alymsys®
  • - MVASI®
  • - Oyavas®
  • - Zirabev®
  • - Vegzelma®
  • - Aybintio®
  • - Breztri®
Drug: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Experimental: Cohort A-2 Arm 2 (R-DXd RP2D + Paclitaxel +/- Bevacizumab)
Participants with PSROC will receive the RP2D of R-DXd in combination with a maximum of 6 cycles of paclitaxel with or without bevacizumab, until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
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.
Other Names:
  • Includes, based on sourcing:
  • - Avastin®
  • - Alymsys®
  • - MVASI®
  • - Oyavas®
  • - Zirabev®
  • - Vegzelma®
  • - Aybintio®
  • - Breztri®
Drug: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Active Comparator: Cohort A-2 Arm 3 (Platinum-Based Doublet Chemotherapy +/- Bevacizumab)
Participants with PSROC will receive one of 3 regimens of investigator's choice of platinum-based doublet chemotherapy with or without bevacizumab. Platinum-based doublet chemotherapy will be administered for maximum of 8 cycles. Bevacizumab can be administered until disease progression or discontinuation.
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.
Other Names:
  • Includes, based on sourcing:
  • - Avastin®
  • - Alymsys®
  • - MVASI®
  • - Oyavas®
  • - Zirabev®
  • - Vegzelma®
  • - Aybintio®
  • - Breztri®
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
Other Names:
  • PLD
Experimental: Cohort D (R-DXd +/- Bevacizumab)
Participants with platinum-sensitive recurrent ovarian cancer (PSROC) receive IV R-DXd in combination with or without bevacizumab until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
Biological: Bevacizumab
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • Includes, based on sourcing:
  • - Avastin®
  • - Alymsys®
  • - MVASI®
  • - Oyavas®
  • - Zirabev®
  • - Vegzelma®
  • - Aybintio®
  • - Breztri®
Drug: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Experimental: Cohort E-1 (R-DXd + MK-2010)
Participants receive escalating doses of IV R-DXd in combination with MK-2010. Participants can receive up to a maximum of thirty-five 3-week cycles of MK-2010 (approximately 2 years) and will receive R-DXd until disease progression or discontinuation.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
Drug: Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Drug: MK-2010
IV infusion on Day 1 of every 3-week cycle
Experimental: Cohort C-2 Arm 1 (Carboplatin + Paclitaxel + Pembrolizumab → R-DXd + Pembrolizumab)
Participants will receive carboplatin (Dose 1 or Dose 2), paclitaxel (five 3-week cycles), and pembrolizumab during the induction phase. During the maintenance phase, participants will receive RP2D of IV R-DXd (up to 2 years; participants with PR or SD at 2 years may continue until disease progression) in combination with pembrolizumab (up to thirty-five 3-week cycles).
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
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: Pembrolizumab
IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.
Experimental: Cohort C-2 Arm 2 (Carboplatin + Paclitaxel)
Participants will receive carboplatin (Dose 1 or Dose 2) and paclitaxel (seven 3-week cycles), followed by standard of care observation.
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.
Experimental: Cohort C-2 Arm 3 (R-DXd + Pembrolizumab + Bevacizumab)
Participants with PSROC will receive RP2D of R-DXd in combination with pembrolizumab (up to thirty-five 3-week cycles) and bevacizumab until progressive disease.
Biological: Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • MK-5909, R-DXd
Biological: Bevacizumab
IV infusion on Day 1 of every 3-week cycle.
Other Names:
  • Includes, based on sourcing:
  • - Avastin®
  • - Alymsys®
  • - MVASI®
  • - Oyavas®
  • - Zirabev®
  • - Vegzelma®
  • - Aybintio®
  • - Breztri®
Biological: Pembrolizumab
IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)
Time Frame: Up to 21 days
DLTs are defined as toxicities during the DLT evaluation period that are assessed by the investigator to be possibly, probably, or definitely related to study treatment and include: Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia lasting ≥7 days; Grade 3 or higher thrombocytopenia associated with clinically significant bleeding; Grade 4 lymphocytopenia lasting ≥14 days; Grade 4 anemia of any duration; any other Grade 4 hematologic toxicity lasting ≥7 days; febrile neutropenia Grade 3 or Grade 4 meeting pre-specifications; pre-specified hepatic organ toxicities; all Grade 3 or higher other nonhematologic toxicities except those pre-specified; other pre-specified nonhematologic toxicities; any delay in treatment with the planned dose of ≥21 days or discontinuation of treatment due to a toxicity during the DLT evaluation period, or Grade 5 toxicity. The number of participants with DLTs will be reported.
Up to 21 days
Part 1: Number of Participants with One or More Adverse Events (AEs)
Time Frame: Up to approximately 3 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with one or more AEs will be reported.
Up to approximately 3 years
Part 1: Number of Participants who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 3 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Up to approximately 3 years
Part 2: Objective Response Rate (ORR)
Time Frame: Up to approximately 3 years
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Up to approximately 3 years
Part 2: Progression Free Survival (PFS) - Cohort C-2 Arm 1 and Arm 2
Time Frame: Up to approximately 3 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Up to approximately 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Objective Response Rate (ORR)
Time Frame: Up to approximately 3 years
ORR is defined as the percentage of participants who have a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST 1.1). ORR will be assessed by blinded independent central review (BICR).
Up to approximately 3 years
Part 2: Duration of Response (DOR)
Time Frame: Up to approximately 3 years
For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.
Up to approximately 3 years
Part 2: Number of Participants with One or More AEs
Time Frame: Up to approximately 3 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Up to approximately 3 years
Part 2: Number of Participants who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 3 years
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Up to approximately 3 years
Part 2: PFS - Cohort A-2 Arm 2 and Arm 3
Time Frame: Up to approximately 3 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Up to approximately 3 years
Part 2: Overall Survival (OS)
Time Frame: Up to approximately 5 years
OS is defined as the time from the first dose of study treatment to death due to any cause.
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Daiichi Sankyo

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2025

Primary Completion (Estimated)

March 27, 2029

Study Completion (Estimated)

February 7, 2031

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

February 25, 2025

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5909-003
  • MK-5909-003 (Other Identifier: MSD)
  • U1111-1308-2821 (Registry Identifier: UTN)
  • 2024-514674-47-00 (Registry Identifier: EU CT)
  • REJOICE-Ovarian02 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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