Actively Recruiting
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-13
460
Participants Needed
17
Research Sites
206 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. 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 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.
CONDITIONS
Official Title
A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 60 months (60180 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 60 months (60180 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 60 months (60180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease)
You will not qualify if you...
- 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 from lung illnesses, autoimmune, connective tissue, or inflammatory disorders with lung involvement, or prior pneumonectomy
- Has grade 2 or higher peripheral neuropathy
- Has received prior treatment with cadherin-6-targeted agents
- Has received systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before allocation
- Has received radiotherapy within 2 weeks of starting study treatment, or has radiation-related toxicities requiring corticosteroids
- Receives chronic steroid treatment
- Has known additional malignancy that is progressing or required active treatment in the past 3 years
- Has known active central nervous system metastases or carcinomatous meningitis
- Has any history of interstitial lung disease or pneumonitis, current or suspected, 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 or Multicentric Castleman's Disease
AI-Screening
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Trial Site Locations
Total: 17 locations
1
The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
Louisville, Kentucky, United States, 40202
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center ( Site 0003)
New York, New York, United States, 10065
Actively Recruiting
3
Houston Methodist Hospital ( Site 0010)
Houston, Texas, United States, 77030
Actively Recruiting
4
START Mountain Region ( Site 0008)
West Valley City, Utah, United States, 84119
Actively Recruiting
5
University of Virginia Health System ( Site 0011)
Charlottesville, Virginia, United States, 22908
Actively Recruiting
6
Rambam Health Care Campus ( Site 0202)
Haifa, Israel, 3109601
Actively Recruiting
7
Shaare Zedek Medical Center ( Site 0201)
Jerusalem, Israel, 9103102
Actively Recruiting
8
Sheba Medical Center ( Site 0200)
Ramat Gan, Israel, 5265601
Actively Recruiting
9
Institut Català d'Oncologia - L'Hospitalet ( Site 0302)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
10
Clinica Universidad de Navarra ( Site 0301)
Madrid, Madrid, Comunidad de, Spain, 28027
Actively Recruiting
11
Hospital General Universitario de Valencia ( Site 0305)
Valencia, Valenciana, Comunitat, Spain, 46014
Actively Recruiting
12
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)
Barcelona, Spain, 08035
Actively Recruiting
13
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)
Madrid, Spain, 28040
Actively Recruiting
14
Hospital Universitario 12 de Octubre ( Site 0304)
Madrid, Spain, 28041
Actively Recruiting
15
Royal Marsden Hospital ( Site 0402)
Fulham, England, United Kingdom, SW3 6JJ
Actively Recruiting
16
The Royal Marsden NHS Foundation Trust. ( Site 0403)
Sutton, England, United Kingdom, SM2 5PT
Actively Recruiting
17
Barts Health NHS Trust ( Site 0401)
London, London, City of, United Kingdom, E1 1RD
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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