Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
Completed · Phase 2
Conditions studied: High-grade Serous Ovarian Carcinoma, Ovarian Carcinoma
In brief
The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor deoxyribonucleic acid (ctDNA) at Cycle 3 (ΔctDNA) is larger in participants receiving MK-4830 + pembrolizumab in combination with standard of care (SOC) therapy than in those receiving pembrolizumab + SOC therapy.
Key facts
- Study ID
- NCT05446870
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 160
- Starts
- 2022-07-25
- Expected to finish
- 2024-10-16
- Last updated by the study team
- 2025-10-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Has histologically-confirmed International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV HGSOC, primary peritoneal cancer, or fallopian tube cancer.
- Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the neoadjuvant and adjuvant setting.
- Is a candidate for interval debulking surgery.
- Is able to provide archival tissue or newly obtained core, incisional, or excisional biopsy of a tumor lesion.
- Has adequate organ functions.
You may not qualify if…
- Has a non-HGSOC histology.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has received prior treatment for any stage of ovarian cancer (OC), including radiation or systemic anticancer therapy.
- Planned or has been administered intraperitoneal chemotherapy as first-line therapy.
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death 1 ligand 1 (PD-L1), anti-programmed cell death 1 ligand 2 (PD-L2), anti-immunoglobulin-like transcript 4 (ILT4), or anti-human leukocyte antigen (HLA)-G agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity to pembrolizumab, carboplatin, paclitaxel (or docetaxel, if applicable), Avastin or biosimilar (if using) and/or any of their excipients.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has an active infection requiring systemic therapy.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of hepatitis B or known active hepatitis C virus infection.
- Has received colony-stimulating factors within 4 weeks prior to receiving study intervention on Day 1 of Cycle 1.
- Has had surgery <6 months prior to Screening to treat borderline ovarian tumors, early-stage OC, or early-stage fallopian tube cancer.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Has current, clinically relevant bowel obstruction.
- Has a history of hemorrhage, hemoptysis, or active gastrointestinal (GI) bleeding within 6 months prior to randomization.
- Has uncontrolled hypertension.
- Has had an allogenic tissue/solid organ transplant.
- Has either had major surgery within 3 weeks of randomization or has not recovered from any effects of any major surgery.
Where it is running
- University of Colorado Anschutz Medical Campus-Cancer Clinical Trials Office ( Site 0108) — Aurora, Colorado, United States
- Mayo Clinic in Florida ( Site 0101) — Jacksonville, Florida, United States
- Miami Cancer Institute at Baptist Health, Inc. ( Site 0110) — Miami, Florida, United States
- Northwestern Memorial Hospital ( Site 0104) — Chicago, Illinois, United States
- Washington University ( Site 0113) — St Louis, Missouri, United States
- Rutgers Cancer Institute of New Jersey ( Site 0114) — New Brunswick, New Jersey, United States
- Roswell Park Cancer Institute ( Site 0106) — Buffalo, New York, United States
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0116) — Mineola, New York, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0107) — New York, New York, United States
- Memorial Sloan Kettering Cancer Center ( Site 0102) — New York, New York, United States
- Sanford Cancer Center-Gynecologic Oncology ( Site 0115) — Sioux Falls, South Dakota, United States
- Fred Hutchinson Cancer Center ( Site 0100) — Seattle, Washington, United States
- Antwerp University Hospital-Oncology ( Site 1301) — Edegem, Antwerpen, Belgium
- AZ Maria Middelares-IKG ( Site 1302) — Ghent, Oost-Vlaanderen, Belgium
- UZ Leuven ( Site 1300) — Leuven, Vlaams-Brabant, Belgium
- Centre Hospitalier de l'Université de Montréal ( Site 0300) — Montreal, Quebec, Canada
- McGill University Health Centre ( Site 0301) — Montreal, Quebec, Canada
- James Lind Centro de Investigación del Cáncer ( Site 0903) — Temuco, Araucania, Chile
- FALP ( Site 0905) — Santiago, Region M. de Santiago, Chile
- Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0900) — Santiago, Region M. de Santiago, Chile
- ONCOCENTRO APYS-ACEREY ( Site 0904) — Viña del Mar, Valparaiso, Chile
- Rambam Health Care Campus-Gyneco-oncology unit ( Site 0602) — Haifa, Israel
- Shaare Zedek Medical Center ( Site 0601) — Jerusalem, Israel
- Sheba Medical Center-ONCOLOGY ( Site 0600) — Ramat Gan, Israel
- Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 0 — Naples, Campania, Italy
Full record on ClinicalTrials.gov
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