NCT05446870CompletedPhase 2
Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 1 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 160 (actual)
- First submitted
- 1 Jul 2022
- Start date
- 25 Jul 2022
- Primary completion date
- 20 Dec 2023
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Ovarian cancer
- NCT number
- NCT05446870
- EU CT number
- 2023-505005-16-00
- EudraCT number
- 2021-005458-27
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 160
- From 25 Jul 2022 to the primary completion date, 20 Dec 2023
- 45 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 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 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 history of hemorrhage, hemoptysis, or active gastrointestinal (GI) bleeding within 6 months prior to randomization.
- 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.
Other illness
- 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 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 a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Has uncontrolled hypertension.
Lab values
- 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.
Other
- Has a non-HGSOC histology.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has current, clinically relevant bowel obstruction.
Who the study is looking for
- 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.
Criteria the registry did not label
- The main inclusion and exclusion criteria include but are not limited to the following:
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (45)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antwerp University Hospital-Oncology ( Site 1301) Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| AZ Maria Middelares-IKG ( Site 1302) Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| UZ Leuven ( Site 1300) Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| Centre Hospitalier de l'Université de Montréal ( Site 0300) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Centre ( Site 0301) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| FALP ( Site 0905) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0900) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| James Lind Centro de Investigación del Cáncer ( Site 0903) Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| ONCOCENTRO APYS-ACEREY ( Site 0904) Coordinator of this site? Confirm its status | Viña del Mar | Chile | Unknown status |
| Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1103) Coordinator of this site? Confirm its status | Hospitalet | Spain | Unknown status |
| Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1104) Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Rambam Health Care Campus-Gyneco-oncology unit ( Site 0602) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Shaare Zedek Medical Center ( Site 0601) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba Medical Center-ONCOLOGY ( Site 0600) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 050 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 0501) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 0 Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502) Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Seoul National University Hospital ( Site 0801) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 0800) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0708) Coordinator of this site? Confirm its status | Kielce | Poland | Unknown status |
| Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 0709) Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0701) Coordinator of this site? Confirm its status | Siedlce | Poland | Unknown status |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| National Cancer Centre Singapore ( Site 1501) Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National University Hospital ( Site 1502) Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Changhua Christian Hospital-Obstetrics and Gynecology ( Site 1203) Coordinator of this site? Confirm its status | Changhua County | Taiwan | Unknown status |
| Taichung Veterans General Hospital-GYNECOLOGY ( Site 1202) Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital ( Site 1201) Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Mackay Memorial Hospital ( Site 1204) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital-Internal Medicine ( Site 1200) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| University of Colorado Anschutz Medical Campus-Cancer Clinical Trials Office ( Site 0108) Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Roswell Park Cancer Institute ( Site 0106) Coordinator of this site? Confirm its status | Buffalo | United States | Unknown status |
| Northwestern Memorial Hospital ( Site 0104) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Mayo Clinic in Florida ( Site 0101) Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Miami Cancer Institute at Baptist Health, Inc. ( Site 0110) Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0116) Coordinator of this site? Confirm its status | Mineola | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey ( Site 0114) Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0107) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center ( Site 0102) Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Fred Hutchinson Cancer Center ( Site 0100) Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Sanford Cancer Center-Gynecologic Oncology ( Site 0115) Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
| Washington University ( Site 0113) Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.