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Brief Title: Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
Official Title: A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer
Study ID: NCT05446870
Brief Summary: The primary objective is to evaluate in participants with high-grade serous ovarian cancer (HGSOC), whether the reduction from baseline in circulating tumor DNA (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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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), Saint 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), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 1300), Leuven, Vlaams-Brabant, Belgium
Centre Hospitalier de l'Université de Montréal ( Site 0300), Montréal, Quebec, Canada
McGill University Health Centre ( Site 0301), Montréal, 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, Napoli, Campania, Italy
Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502), Roma, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 050, Milan, Lombardia, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 0501), Milano, , Italy
Seoul National University Hospital ( Site 0801), Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 0800), Seoul, , Korea, Republic of
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0701), Siedlce, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi, Gdańsk, Pomorskie, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0708), Kielce, Swietokrzyskie, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 0709), Poznan, Wielkopolskie, Poland
National Cancer Centre Singapore ( Site 1501), Singapore, Central Singapore, Singapore
National University Hospital ( Site 1502), Singapore, South West, Singapore
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, , Taiwan
National Taiwan University Hospital-Internal Medicine ( Site 1200), Taipei, , Taiwan
Mackay Memorial Hospital ( Site 1204), Taipei, , Taiwan
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR