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A Study of Raludotatug Deruxtecan for Recurrent Ovarian Cancer

This study is looking for new ways to treat high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that has come back (recurrent). Researchers are testing a study treatment called Raludotatug Deruxtecan (R-DXd), which is an antibody drug conjugate (ADC). You might also receive standard treatments like Carboplatin, Paclitaxel, or Bevacizumab. The study aims to understand the side effects of R-DXd and how many people experience them, as well as how many people need to stop treatment due to side effects. You may be able to join if you are an adult woman with a confirmed diagnosis of these cancers, have measurable disease, and your cancer has returned after 1 to 3 previous treatments.

Study design
This is an interventional study with an estimated enrollment of 460 participants. It has two parts: a dose escalation phase and an expansion phase.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06843447

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~460 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Raludotatug DeruxtecanCarboplatinPaclitaxelBevacizumabRescue MedicationPembrolizumab

At a glance

Recruiting sites
29 of 30 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Up to 21 days
+3 more outcomes measured

Conditions

Ovarian Cancer Recurrent

Explore related trials

Fallopian Tube CarcinomaMalignant Ovarian NeoplasmPrimary Peritoneal Cancer

Where it's being run

30 sites across 20 states
Israel4
Spain4
Texas2
Quebec2
England2
London, City of2
Connecticut1
Kentucky1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 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 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/randomization
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/randomization
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
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)

Exclusion

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

What this trial measures

  • 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)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.

  • Part 1: Number of Participants with One or More Adverse Events (AEs)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.

  • Part 1: Number of Participants who Discontinue Study Intervention Due to an AEUp 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.

  • Part 2: Objective Response Rate (ORR)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.