A Phase Ib/II 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
Study Identifier:
MK-5909-003
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
To evaluate R-DXd is safe to take with standard treatment and if people tolerate them together.
To assess safety, tolerability, and preliminary antitumor activity of R-DXd combined with carboplatin or paclitaxel in pts with platinum-sensitive recurrent OC (PSOC) or with bevacizumab in pts with platinum-resistant recurrent OC (PROC).
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female
Age
18+ years
Study Drug
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Inclusion Criteria: 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 criteria
- 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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Bernard Doger de Speville
Status
Recruiting
Condition(s) Treated at Site
Ovarian