Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
NCT ID: NCT05446870
Last Updated: 2025-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2022-07-25
2024-10-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab + Standard of Care (SOC) + MK-4830
Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2 (or docetaxel 75 mg/m\^2), carboplatin Area Under the Curve (AUC) 5 to 6, and MK-4830 800 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2 (or docetaxel 75 mg/m\^2), carboplatin AUC 5 to 6, and MK-4830 800 mg (with avastin \[or biosimilar\] at the investigator's discretion and per insitutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
Pembrolizumab
200 mg by IV infusion on Day 1 of each 21-day cycle
Paclitaxel
175 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
Carboplatin
AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle
Avastin
According to local practice and at the choice of the investigator.
MK-4830
800 mg by IV infusion on Day 1 of each 21-day cycle
Docetaxel
75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
Pembrolizumab + SOC
Before surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2 (or docetaxel 75 mg/m\^2), and carboplatin AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles. After surgery participants will receive pembrolizumab 200 mg, paclitaxel 175 mg/m\^2 (or docetaxel 75 mg/m\^2), and carboplatin AUC 5 to 6 (with avastin \[or biosimilar\] at the investigator's discretion and per insitutional guidelines) by IV infusion on Day 1 of each 21-day cycle (Q3W) for 3 cycles.
Pembrolizumab
200 mg by IV infusion on Day 1 of each 21-day cycle
Paclitaxel
175 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
Carboplatin
AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle
Avastin
According to local practice and at the choice of the investigator.
Docetaxel
75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
Interventions
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Pembrolizumab
200 mg by IV infusion on Day 1 of each 21-day cycle
Paclitaxel
175 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
Carboplatin
AUC 5 to 6 by IV infusion on Day 1 of each 21-day cycle
Avastin
According to local practice and at the choice of the investigator.
MK-4830
800 mg by IV infusion on Day 1 of each 21-day cycle
Docetaxel
75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
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
James Lind Centro de Investigación del Cáncer ( Site 0903)
Temuco, Región de la Araucanía, Chile
ONCOCENTRO APYS-ACEREY ( Site 0904)
Viña del Mar, Región de Valparaíso, 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
Napoli, Campania, Italy
Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 050
Milan, Lombardy, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 0501)
Milan, , Italy
Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 0709)
Poznan, Greater Poland Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0701)
Siedlce, Masovian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
Gdansk, Pomeranian Voivodeship, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0708)
Kielce, Świętokrzyskie Voivodeship, Poland
National Cancer Centre Singapore ( Site 1501)
Singapore, Central Singapore, Singapore
National University Hospital ( Site 1502)
Singapore, South West, Singapore
Seoul National University Hospital ( Site 0801)
Seoul, , South Korea
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 0800)
Seoul, , South Korea
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1103)
Hospitalet, Barcelona, Spain
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1104)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
Barcelona, , Spain
Changhua Christian Hospital-Obstetrics and Gynecology ( Site 1203)
Changhua County, Changhua, Taiwan
Taichung Veterans General Hospital-GYNECOLOGY ( Site 1202)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 1201)
Tainan City, , Taiwan
National Taiwan University Hospital-Internal Medicine ( Site 1200)
Taipei, , Taiwan
Mackay Memorial Hospital ( Site 1204)
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-4830-002
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505005-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1290-6634
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-005458-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
4830-002
Identifier Type: -
Identifier Source: org_study_id
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