A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
NCT ID: NCT06843447
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
280 participants
INTERVENTIONAL
2025-04-15
2029-03-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Imaging data will be centrally reviewed by independent radiologist(s) without knowledge of participant dose assignment.
Study Groups
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Cohort A-1 Arm 1 (R-DXd + Carboplatin Dose 1)
Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan 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.
Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Carboplatin
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Cohort A-1 Arm 2 (R-DXd + Paclitaxel)
Participants receive escalating doses of IV raludotatug deruxtecan in combination with paclitaxel. Participants can receive up to a maximum of six 3-week cycles of paclitaxel (approximately 4 months) and will receive raludotatug deruxtecan until disease progression or discontinuation.
Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Paclitaxel
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Cohort A-1 Arm 3 (R-DXd + Carboplatin Dose 2)
Participants receive escalating doses of intravenous (IV) raludotatug deruxtecan 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 raludotatug deruxtecan until disease progression or discontinuation.
Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Carboplatin
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Cohort B-1 (R-DXd + Bevacizumab)
Participants receive escalating doses of IV raludotatug deruxtecan in combination with bevacizumab until disease progression or discontinuation.
Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Bevacizumab
IV infusion on Day 1 of every 3-week cycle.
Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Cohort B-2 (R-DXd Phase 2 + Bevacizumab)
Participants with platinum-resistant recurrent ovarian cancer (PRROC) receive recommended Phase 2 dose (RP2D) of IV raludotatug deruxtecan in combination with bevacizumab until disease progression or discontinuation.
Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Bevacizumab
IV infusion on Day 1 of every 3-week cycle.
Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Cohort C-1 (R-DXd + Pembrolizumab)
Participants receive escalating doses of IV raludotatug deruxtecan 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 raludotatug deruxtecan until disease progression or discontinuation.
Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Pembrolizumab
IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.
Cohort D (R-DXd Phase 2 +/- Bevacizumab)
Participants with platinum-sensitive recurrent ovarian cancer (PSROC) receive RP2D of IV raludotatug deruxtecan in combination with or without bevacizumab until disease progression or discontinuation.
Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Bevacizumab
IV infusion on Day 1 of every 3-week cycle.
Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Interventions
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Raludotatug Deruxtecan
IV infusion on Day 1 of every 3-week cycle.
Carboplatin
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Paclitaxel
IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles.
Bevacizumab
IV infusion on Day 1 of every 3-week cycle.
Rescue Medication
Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol.
Pembrolizumab
IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Daiichi Sankyo
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
Louisville, Kentucky, United States
Memorial Sloan Kettering Cancer Center ( Site 0003)
New York, New York, 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
Rambam Health Care Campus ( Site 0202)
Haifa, , Israel
Shaare Zedek Medical Center ( Site 0201)
Jerusalem, , Israel
Sheba Medical Center ( Site 0200)
Ramat Gan, , Israel
Institut Català d'Oncologia - L'Hospitalet ( Site 0302)
L'Hospitalet de Llobregat, Barcelona, Spain
Clinica Universidad de Navarra ( Site 0301)
Madrid, Madrid, Comunidad de, 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
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
Countries
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Central Contacts
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Facility Contacts
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Study Coordinator
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Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-5909-003
Identifier Type: OTHER
Identifier Source: secondary_id
2024-514674-47-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1308-2821
Identifier Type: REGISTRY
Identifier Source: secondary_id
REJOICE-Ovarian02
Identifier Type: OTHER
Identifier Source: secondary_id
5909-003
Identifier Type: -
Identifier Source: org_study_id
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