Pembrolizumab With Chemotherapy and MK-4830 for Treating Participants With Ovarian Cancer (MK-4830-002)
- Trial number:
- NCT05446870
- Trial phase:
- 2
- Study type:
- Immunotherapy, Chemotherapy
- Overall status:
- Recruiting
Study start date
July, 2022
Scientific title
A Randomized, Phase 2 Study of Pembrolizumab And Chemotherapy With or Without MK-4830 as Neoadjuvant Treatment for High-Grade Serous Ovarian Cancer
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.
The main inclusion and exclusion criteria include but are not limited to the following:
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.
Study design
Primary purpose:
Treatment, Allocation:
Randomized, Intervention model:
Parallel Assignment, Masking:
None (Open Label),
Conditions
High-grade Serous Ovarian Carcinoma, Ovarian Carcinoma
Other study ID numbers
4830-002; MK-4830-002; 2021-005458-27
Choose trial site (55)
Rutgers Cancer Institute of New Jersey ( Site 0114)
195 Little Albany St, New Brunswick, NJ 08901, USA
FALP ( Site 0905)
José Manuel Infante 805, Providencia, Región Metropolitana, Chile
ONCOCENTRO APYS-ACEREY ( Site 0904)
Avenida - La Marina #1702, Valparaíso, Viña del Mar 2520598, Valparaíso, Chile
Rambam Health Care Campus-Gyneco-oncology unit ( Site 0602)
HaAliya HaShniya St 8, Haifa, 3109601, Israel
Shaare Zedek Medical Center ( Site 0601)
Shmu'el Bait St 12, Jerusalem, 9103102, Israel
Sheba Medical Center-ONCOLOGY ( Site 0600)
Ramat Gan, Israel
Seoul National University Hospital ( Site 0801)
101 Daehak-ro, Jongno-gu, Seoul, South Korea
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 0800)
50-1 Yonsei-ro, Sinchon-dong, Seodaemun-gu, Seoul, South Korea
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 0701)
ul. Poniatowskiego 26, 08-110 Siedlce, Poland
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 0708)
Prezydenta Stefana Artwińskiego 3, 25-734 Kielce, Poland
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1103)
Avinguda de la Granvia de l’Hospitalet, 199, 08908 L'Hospitalet de Llobregat, Barcelona, Spain
Changhua Christian Hospital-Obstetrics and Gynecology ( Site 1203)
No. 176, Zhonghua Rd, Changhua City, Changhua County, Taiwan 500
Taichung Veterans General Hospital-GYNECOLOGY ( Site 1202)
No. 1650號, Section 4, Taiwan Blvd, Xitun District, Taichung City, Taiwan 40705
National Cheng Kung University Hospital ( Site 1201)
No. 138號, Shengli Rd, North District, Tainan City, Taiwan 704
National Taiwan University Hospital-Internal Medicine ( Site 1200)
No. 7號, Zhongshan S Rd, Zhongzheng District, Taipei City, Taiwan 100
National Cancer Centre Singapore
University of Colorado Anschutz Medical Campus-Cancer Clinical Trials Office ( Site 0108)
12648 E 17th Ave, Aurora, CO 80045, USA
Northwestern Memorial Hospital ( Site 0104)
251 E Huron St, Chicago, IL 60611, USA
Washington University ( Site 0113)
4559 Scott Ave, St. Louis, MO 63110, USA
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0116)
259 1st St, Mineola, NY 11501, USA
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0107)
240 E 38th St 19th Floor, New York, NY 10016, USA
Memorial Sloan Kettering Cancer Center ( Site 0102)
Ed Koch Queensboro Bridge Upper Roadway, New York, NY 10022, USA
Sanford Cancer Center-Gynecologic Oncology ( Site 0115)
1309 W 17th St, Sioux Falls, SD 57104, USA
AZ Maria Middelares-IKG ( Site 1302)
Ghent, Belgium
UZ Leuven ( Site 1300)
Herestraat 49, 3000 Leuven, Belgium
Centre Hospitalier de l'Université de Montréal ( Site 0300)
1051 Rue Sanguinet, Montréal, QC H2X 3E4, Canada
McGill University Health Centre ( Site 0301)
1001 Bd Décarie, Montréal, QC H4A 3J1, Canada
James Lind Centro de Investigación del Cáncer ( Site 0903)
Hochstetter 298, 4780000 Temuco, Araucanía, Chile
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 0900)
Av. Libertador Bernardo O'Higgins 340, 8331150 Santiago, Región Metropolitana, Chile
Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502)
Largo Agostino Gemelli, 8, 00168 Roma RM, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Chirurgia Ginecologica ( Site 050
Via Giacomo Venezian, 1, 20133 Milano MI, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 0501)
20141 Milan, Metropolitan City of Milan, Italy
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit
Wilhelma Konrada Roentgena 5, 05-077 Warszawa, Poland
Uniwersyteckie Centrum Kliniczne-Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Gi
Kliniczna 1A, 80-402 Gdańsk, Poland
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-Oddzial Ginekologii Onkologicznej ( Sit
Jarochowskiego 18, 60-235 Poznań, Poland
National Cancer Centre Singapore ( Site 1501)
11 Hospital Cres, Singapore 169610
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1104)
Av. de Córdoba, s/n, 28041 Madrid, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1101)
Centro Cellex, Carrer de Natzaret, 115, 117, 08035 Barcelona, Spain
Mackay Memorial Hospital ( Site 1204)
No. 92號, Section 2, Zhongshan N Rd, Zhongshan District, Taipei City, Taiwan 104
Mayo Clinic in Florida ( Site 0101)
201-299 2nd Ave SW, Rochester, MN 55902, USA
Centre Hospitalier de l'Université de Montréal ( Site 0300)
1051 Rue Sanguinet, Montréal, QC H2X 3E4, Canada
James Lind Centro de Investigación del Cáncer ( Site 0903)
Hochstetter 298, 4780000 Temuco, Araucanía, Chile
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 0
80131 Naples, Metropolitan City of Naples, Italy
Antwerp University Hospital-Oncology ( Site 1301)
Drie Eikenstraat 655, 2650 Edegem, Belgium
Uniwersytecki Szpital Kliniczny w Poznaniu-Oddzial Ginekologii Onkologicznej ( Site 0709)
Długa 1/2, 61-848 Poznań, Poland
Mackay Memorial Hospital ( Site 1204)
No. 92號, Section 2, Zhongshan N Rd, Zhongshan District, Taipei City, Taiwan 104
Roswell Park Cancer Institute ( Site 0106)
665 Elm St, Buffalo, NY 14203, USA
Fred Hutchinson Cancer Center ( Site 0100)
1354 Aloha St, Seattle, WA 98109, USA
National Cancer Centre Singapore ( Site 1501)
30 Hospital Blvd, Singapore 168583
Rutgers Cancer Institute of New Jersey ( Site 0114)
195 Little Albany St, New Brunswick, NJ 08901, USA
James Lind Centro de Investigación del Cáncer ( Site 0903)
Hochstetter 298, 4780000 Temuco, Araucanía, Chile
Fondazione Policlinico Universitario Agostino Gemelli-Ginecologia Oncologica ( Site 0502)
Largo Agostino Gemelli, 8, 00168 Roma RM, Italy
National University Hospital ( Site 1502)
5 Lower Kent Ridge Rd, Singapore 119074
Miami Cancer Institute at Baptist Health, Inc. ( Site 0110)
Palmetto Bay, FL 33176, USA
FALP ( Site 0905)
José Manuel Infante 805, 7500921 Providencia, Región Metropolitana, Chile