Actively Recruiting
A Phase 1b/2 Study to Evaluate Safety and Efficacy of Raludotatug Deruxtecan With Other Anticancer Agents in Relapsed High-grade Serous Ovarian, Peritoneal, or Fallopian Tube Cancer
Led by Merck Sharp & Dohme LLC · Updated on 2026-06-08
460
Participants Needed
22
Research Sites
N/A
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 evaluating new treatments for relapsed high-grade serous ovarian cancer, a fast-growing cancer that starts in the cells covering the ovaries, lining of the belly, or fallopian tubes. This cancer has returned after prior treatment, and the study aims to understand how well the antibody drug conjugate raludotatug deruxtecan (R-DXd) works when combined with other anticancer agents. The study is a Phase 1b/2 trial designed to assess the safety and effectiveness of these combinations in patients who have relapsed after platinum-based chemotherapy. The study has two parts: Part 1 tests increasing doses of R-DXd combined with chemotherapy drugs carboplatin or paclitaxel, or with bevacizumab and pembrolizumab, to find the safest and most effective dose. Part 2 uses the recommended dose from Part 1 to further evaluate these combinations. Treatment cycles occur every 3 weeks, with up to six cycles of chemotherapy drugs and up to 35 cycles of pembrolizumab. Participants continue receiving R-DXd until their disease progresses or treatment is stopped. Participants will undergo regular assessments including scans to measure tumor response, monitoring for side effects, and evaluations of overall health. The main outcomes are safety measures like dose-limiting toxicities and adverse events, as well as how many participants experience shrinkage or disappearance of tumors. The study may last up to about three years, with ongoing monitoring of treatment effects and safety throughout the trial period.
CONDITIONS
Brief 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...
- Female participants aged 18 years or older
- Diagnosed with high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- Have measurable disease according to Response Evaluation Criteria In Solid Tumors 1.1
- For Cohort A-1 Arms 2 and 3: Relapsed disease after 1 to 3 prior therapies with progression 6 months or more after last platinum-based therapy (platinum-sensitive)
- For Cohorts B-1 and B-2: Relapsed disease after 1 to 3 prior therapies with progression less than 6 months after last platinum-based therapy (platinum-resistant)
- Candidates for bevacizumab treatment (for Cohorts B-1 and B-2)
- Provided tumor tissue from a biopsy not previously irradiated
- Eastern Cooperative Oncology Group performance status of 0 to 1 within 7 days before enrollment
- HIV-infected participants must have well-controlled HIV on therapy
- Hepatitis B surface antigen positive participants must have received antiviral therapy for at least 4 weeks with undetectable viral load
- History of hepatitis C infection must have undetectable viral load at screening
- For Cohorts C-1 and D: Relapsed disease after 1 prior therapy with progression 6 months or more after last platinum-based therapy and progression during prior PARP inhibitor treatment
- For Cohort A-2 Arms 1, 2, and 3: Relapsed disease after 1 prior therapy with progression 6 months or more after last platinum-based therapy (platinum-sensitive)
You will not qualify if you...
- History of cerebrovascular accident, transient ischemic attack, or arterial thromboembolic event within 6 months before enrollment
- Uncontrolled or significant cardiovascular disease
- Severe lung problems from illnesses, autoimmune or inflammatory disorders affecting lungs, or prior lung removal
- Peripheral neuropathy of grade 2 or higher
- Prior treatment with cadherin-6-targeted agents
- Systemic anticancer therapy including investigational drugs within 4 weeks or 5 half-lives before enrollment
- Radiotherapy within 2 weeks before study start or radiation-related toxicities needing corticosteroids
- Chronic steroid treatment
- Other active malignancies progressing or treated within past 3 years
- Active central nervous system metastases or carcinomatous meningitis
- History or suspicion of interstitial lung disease or pneumonitis
- Active infections requiring systemic therapy
- HIV participants with history of Kaposi's sarcoma or Multicentric Castleman's Disease
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years or until disease progression or discontinuation
Participants receive intravenous raludotatug deruxtecan (R-DXd) combined with other anticancer agents. Some participants receive up to six 3-week cycles of carboplatin or paclitaxel (approximately 4 months). Others may receive up to 35 cycles of pembrolizumab (approximately 2 years). Treatment with R-DXd continues until disease progression or discontinuation.
IV infusions on Day 1 of every 3-week cycle; some regimens include additional infusions on Day 8 or 4-week cycles depending on combination treatment
Trial Site Locations
Total: 22 locations
1
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
The University of Louisville, James Graham Brown Cancer Center ( Site 0009)
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
Dana-Farber Cancer Institute ( Site 0015)
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center ( Site 0003)
New York, New York, United States, 10065
Actively Recruiting
5
OU Health University of Oklahoma Medical Center ( Site 7000)
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
6
Houston Methodist Hospital ( Site 0010)
Houston, Texas, United States, 77030
Actively Recruiting
7
START Mountain Region ( Site 0008)
West Valley City, Utah, United States, 84119
Actively Recruiting
8
University of Virginia Health System ( Site 0011)
Charlottesville, Virginia, United States, 22908
Actively Recruiting
9
Rambam Health Care Campus ( Site 0202)
Haifa, Israel, 3109601
Actively Recruiting
10
Shaare Zedek Medical Center ( Site 0201)
Jerusalem, Israel, 9103102
Actively Recruiting
11
Sheba Medical Center ( Site 0200)
Ramat Gan, Israel, 5265601
Actively Recruiting
12
Institut Català d'Oncologia - L'Hospitalet ( Site 0302)
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
Actively Recruiting
13
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)
Majadhonda, Madrid, Spain, 28222
Actively Recruiting
14
Clinica Universidad de Navarra ( Site 0301)
Madrid, Madrid, Comunidad de, Spain, 28027
Actively Recruiting
15
Hospital General Universitario de Valencia ( Site 0305)
Valencia, Valenciana, Comunitat, Spain, 46014
Actively Recruiting
16
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)
Barcelona, Spain, 08035
Actively Recruiting
17
Hospital Universitario Fundación Jiménez DÃaz-START Madrid-FJD ( Site 0303)
Madrid, Spain, 28040
Actively Recruiting
18
Hospital Universitario 12 de Octubre ( Site 0304)
Madrid, Spain, 28041
Actively Recruiting
19
Hospital Universitario Virgen de la Victoria ( Site 0306)
Málaga, Spain, 29010
Actively Recruiting
20
Royal Marsden Hospital ( Site 0402)
Fulham, England, United Kingdom, SW3 6JJ
Actively Recruiting
21
The Royal Marsden NHS Foundation Trust. ( Site 0403)
Sutton, England, United Kingdom, SM2 5PT
Actively Recruiting
22
Barts Health NHS Trust ( Site 0401)
London, London, City of, United Kingdom, E1 1RD
Actively Recruiting
Research Team
T
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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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