A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)
A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab Versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)
The purpose of this study is to assess the safety and efficacy of treatment with pembrolizumab (MK-3475) compared to a combination of carboplatin and paclitaxel in women with mismatch repair deficient (dMMR) advanced or recurrent endometrial carcinoma who have not previously been treated with prior systemic chemotherapy.
The primary study hypotheses are that pembrolizumab is superior to the combination of carboplatin and paclitaxel with respect to Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS).
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Has a histologically confirmed diagnosis of inoperable, Stage III or IV or recurrent Endometrial Carcinoma (EC) or carcinosarcoma (mixed Mullerian tumor) that is centrally confirmed as dMMR.
Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the investigator. Note: primary Stage IVB that has undergone surgical resection is allowed regardless of presence of measurable or evaluable disease.
Has received no prior systemic therapy for EC except for the following:
Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization.
Is not pregnant or breastfeeding and agrees to not donate eggs and use a highly effective contraceptive method for 120 days after the last dose of pembrolizumab or 180 days after the last dose of chemotherapy if a woman of childbearing potential (WOCBP).
Has a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or 72 hours for serum before the first dose of study intervention if a WOCBP.
Provides an archival tumor tissue sample or newly obtained (core, incisional, or excisional) biopsy of a tumor lesion not previously irradiated for verification of dMMR status and histology.
If Hepatitis B surface antigen (HBsAg) positive, has received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load prior to randomization.
If has a history of Hepatitis C virus (HCV) infection, has undetectable HCV viral load at screening.
Exclusion Criteria:
New Haven, Connecticut 06511, United States
Zion, Illinois 60099, United States
Indianapolis, Indiana 46260, United States
Rockville, Maryland 20850, United States
Worcester, Massachusetts 01605, United States
Hackensack, New Jersey 07601, United States
New York, New York 10011, United States
New York, New York 10016, United States
Fargo, North Dakota 58102, United States
Cincinnati, Ohio 45219, United States
Columbus, Ohio 43210, United States
Philadelphia, Pennsylvania 19107, United States
Pittsburgh, Pennsylvania 15213, United States
Sioux Falls, South Dakota 57104, United States
Dallas, Texas 75246, United States
Tyler, Texas 75702, United States
Westmead, New South Wales 2145, Australia
Brisbane, Queensland 4029, Australia
Melbourne, Victoria 3000, Australia
Subiaco, Western Australia 6008, Australia
Brussels, Bruxelles-Capitale, Region de 1000, Belgium
Liège, Liege 4000, Belgium
Natal, Rio Grande do Norte 59075-740, Brazil
Saskatoon, Saskatchewan S7N 4H4, Canada
Beijing, Beijing Municipality 100026, China
Chongqing, Chongqing Municipality 400038, China
Chongqing, Chongqing Municipality 400072, China
Fulingqu, Chongqing Municipality 408000, China
Nanning, Guangxi 530021, China
Shanghai, Shanghai Municipality 200011, China
Shanghai, Shanghai Municipality 201204, China
Tianjin, Tianjin Municipality 300060, China
Hangzhou, Zhejiang 310000, China
Wenzhou, Zhejiang 325000, China
Brno, Brno-mesto 62500, Czechia
Ostrava, Moravian-Silesian Region 708 52, Czechia
Nový Jiín, Novy Jicin 741 01, Czechia
Prague, Praha 2 12808, Czechia
Prague, Praha 8 180 00, Czechia
Prague, 10034, Czechia
Tampere, Pirkanmaa 33520, Finland
Helsinki, Uusimaa 00290, Finland
Bonn, North Rhine-Westphalia 53127, Germany
Dresden, Saxony 01307, Germany
Naples, Campania 80131, Italy
Bologna, Emilia-Romagna 40138, Italy
Meldola, Emilia-Romagna 47014, Italy
Milan, Lombardy 20133, Italy
Florence, Tuscany 50134, Italy
Milan, 20141, Italy
Roma, 00168, Italy
Otashi, Gunma 373-8550, Japan
Shiwa-gun Yahaba-cho, Iwate 028-3695, Japan
Hidaka-shi, Saitama 350-1200, Japan
Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto, Tokyo 135-8550, Japan
Minato-ku, Tokyo 105-8471, Japan
Shinjyuku-ku, Tokyo 160-8582, Japan
Osaka, 541-8567, Japan
Leiden, South Holland 2333 ZA, Netherlands
Poznan, Greater Poland Voivodeship 61-848, Poland
Siedlce, Masovian Voivodeship 08-110, Poland
Warsaw, Masovian Voivodeship 00-315, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Bialystok, Podlaskie Voivodeship 15-027, Poland
Gliwice, Silesian Voivodeship 44-102, Poland
Kielce, Świętokrzyskie Voivodeship 25-734, Poland
Seoul, 03722, South Korea
Seoul, 05505, South Korea
L'Hospitalet de Llobregat, Barcelona 08908, Spain
Madrid, Madrid, Comunidad de 28034, Spain
Valencia, Valenciana, Comunitat 46009, Spain
Lund, Skåne County 22185, Sweden
Istanbul, 34093, Turkey (Türkiye)
Glasgow, Glasgow City G12 0YN, United Kingdom