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ACTIVE NOT RECRUITING

NCT04634877

PHASE3

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.

Official title: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

990

Start Date

2021-01-10

Completion Date

2026-11-20

Last Updated

2026-09-18

Healthy Volunteers

Conditions

Endometrial Neoplasms

Interventions

BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Placebo for pembrolizumab

IV infusion

DRUG

Docetaxel

IV infusion docetaxel 75 mg/m\^2 Q3W or 25 mg/m2 QW may be given in place of paclitaxel following sponsor consultation if a participant experiences severe hypersensitivity to paclitaxel or an adverse event requiring discontinuation of paclitaxel.

DRUG

Cisplatin

Cisplatin 75 mg/m\^2 IV infusion Q3W may be given in place of carboplatin following sponsor consultation if a participant experiences severe hypersensitivity to carboplatin or an adverse event requiring discontinuation of carboplatin.

RADIATION

External Beam Radiotherapy (EBRT)

≥4500 cGY given according to local practice, at the discretion of the investigator

DRUG

Cisplatin (as radiosensitizer)

If a participant receives external beam radiotherapy (EBRT), then cisplatin 50 mg/m\^2 IV infusion may be administered as a radiosensitizer at the discretion of the investigator, on days 1 and 29

RADIATION

Brachytherapy

Given according to local practice, at the discretion of the investigator

Inclusion Criteria: * Has a histologically confirmed new diagnosis of Endometrial Carcinoma or Carcinosarcoma (Mixed Mullerian Tumor) and: * Has undergone curative intent surgery that included hysterectomy and bilateral salpingo-oophorectomy; and * Is at high risk for recurrence following treatment with curative intent surgery, ie: Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) 2009 surgical stage I/II with myometrial invasion of non-endometrioid histology; FIGO 2009 surgical stage I/II with myometrial invasion of any histology with known aberrant p53 expression or p53 mutation; or FIGO (2009) surgical stage III or IVA of any histology. * Is disease-free with no evidence of loco-regional disease or distant metastasis post operatively and on imaging. * Has not received any radiation or systemic therapy, including immunotherapy, hormonal therapy, or hyperthermic intraperitoneal chemotherapy (HIPEC), in any setting including the neoadjuvant setting for endometrial cancer (EC). * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before randomization. * Submission of a tumor tissue sample from current diagnosis of Endometrial Carcinoma or Carcinosarcoma for prospective determination of histology and mismatch repair (MMR) status by central vendor is required for all participants. * Has adequate organ function within 7 days of randomization. Exclusion Criteria: * Has recurrent endometrial carcinoma or carcinosarcoma. * Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed. * Has FIGO (2009) Surgical Stage I/II EC of endometrioid histology without a known aberrant p53 expression or p53 mutation. * Is known to have a deoxyribonucleic acid (DNA) polymerase epsilon catalytic subunit A (POLE) mutation. * Has FIGO Stage IVB disease of any histology even if there is no evidence of disease after surgery. * Has residual tumor whether measurable or non-measurable after surgery. * Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years. * Note: The time requirement does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ cervical cancer, or other in situ cancers. * Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137). * Has received a live vaccine within 30 days before the first dose of study intervention. * Note: killed vaccines are allowed. * Has a known intolerance to study intervention (or any of the excipients). * 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. * Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent. * Has any contraindication to the use of carboplatin or paclitaxel. * 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 intervention. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients. * Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed. * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * Has an active infection requiring systemic therapy. * Has a known history of 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 had an allogenic tissue/solid organ transplant. * Has not recovered adequately from surgery and/or any complications from the surgery. * Is breastfeeding.

Locations (231)

University of Alabama - Birmingham ( Site 3061)

Birmingham, Alabama, United States

University of South Alabama, Mitchell Cancer Institute ( Site 3058)

Mobile, Alabama, United States

HonorHealth Research Institute - Biltmore ( Site 3043)

Phoenix, Arizona, United States

Arizona Oncology Associates PC- HOPE ( Site 3049)

Tucson, Arizona, United States

UCSD Moores Cancer Center ( Site 3053)

La Jolla, California, United States

University Of Colorado ( Site 3051)

Aurora, Colorado, United States

Smilow Cancer Hospital at Yale New Haven ( Site 3070)

New Haven, Connecticut, United States

Mount Sinai Cancer Center ( Site 3081)

Miami Beach, Florida, United States

Northside Hospital ( Site 3036)

Atlanta, Georgia, United States

Northwestern Memorial Hospital ( Site 3044)

Chicago, Illinois, United States

Parkview Cancer Institute ( Site 3067)

Fort Wayne, Indiana, United States

Indiana University Melvin and Bren Simon Cancer Center ( Site 3071)

Indianapolis, Indiana, United States

University of Iowa Hospital and Clinics ( Site 3046)

Iowa City, Iowa, United States

Norton Cancer Institute - St. Matthews ( Site 3056)

Louisville, Kentucky, United States

WK Physicians Network/Gynecologic Oncology Associates ( Site 3047)

Shreveport, Louisiana, United States

University of Massachusetts Medical School-Division of Gynecologic Oncology ( Site 3037)

Worcester, Massachusetts, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076)

Mineola, New York, United States

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042)

New York, New York, United States

Montefiore Medical Center ( Site 3065)

The Bronx, New York, United States

Duke Cancer Center ( Site 3072)

Durham, North Carolina, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080)

Fargo, North Dakota, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 3066)

Columbus, Ohio, United States

Legacy Good Samaritan Medical Center ( Site 3033)

Portland, Oregon, United States

Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078)

Philadelphia, Pennsylvania, United States

AHN West Penn Hospital ( Site 3060)

Pittsburgh, Pennsylvania, United States

Abington Hospital - Asplundh Cancer Center ( Site 3073)

Willow Grove, Pennsylvania, United States

Sanford Gynecology Oncology ( Site 3045)

Sioux Falls, South Dakota, United States

UT Southwestern Medical Center ( Site 3063)

Dallas, Texas, United States

VCU Massey Cancer Center ( Site 3068)

Richmond, Virginia, United States

Centro de Oncología e Investigación de Buenos Aires ( Site 1005)

Berazategui, Buenos Aires, Argentina

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006)

CABA, Buenos Aires, Argentina

CEMIC ( Site 1009)

CABA, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires ( Site 1002)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003)

Mar del Plata, Buenos Aires, Argentina

Instituto de Oncologia de Rosario ( Site 1004)

Rosario, Santa Fe Province, Argentina

IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010)

Buenos Aires, Argentina

Hospital Aleman ( Site 1001)

Buenos Aires, Argentina

Centro Oncologico Riojano Integral ( Site 1007)

La Rioja, Argentina

Medizinische Universitat Graz ( Site 2004)

Graz, Styria, Austria

Medizinische Universitaet Innsbruck ( Site 2001)

Innsbruck, Tyrol, Austria

Saint-Luc UCL ( Site 2042)

Brussels, Bruxelles-Capitale, Region de, Belgium

C.I.U. Hopital Ambroise Pare ( Site 2039)

Mons, Hainaut, Belgium

CHR Verviers ( Site 2035)

Verviers, Liege, Belgium

AZORG Campus Aalst-Moorselbaan ( Site 2038)

Aalst, Oost-Vlaanderen, Belgium

AZ Maria Middelares Gent ( Site 2032)

Ghent, Oost-Vlaanderen, Belgium

Universitair Ziekenhuis Gent ( Site 2037)

Ghent, Oost-Vlaanderen, Belgium

AZ Nikolaas ( Site 2031)

Sint-Niklaas, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 2040)

Leuven, Vlaams-Brabant, Belgium

AZ Groeninge ( Site 2036)

Kortrijk, West-Vlaanderen, Belgium

CHC - Groupe Sante ( Site 2041)

Liège, Belgium

CHU Liege Sart-Tilman ( Site 2044)

Liège, Belgium

Arthur J.E. Child Comprehensive Cancer Centre ( Site 3007)

Calgary, Alberta, Canada

Kingston Health Sciences Centre ( Site 3003)

Kingston, Ontario, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 3006)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 3005)

Montreal, Quebec, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3002)

Québec, Quebec, Canada

Centro Investigación del Cáncer James Lind ( Site 1061)

Temuco, Araucania, Chile

Fundacion Arturo Lopez Perez FALP ( Site 1062)

Santiago, Region M. de Santiago, Chile

Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)

Santiago, Region M. de Santiago, Chile

Bradfordhill-Clinical Area ( Site 1070)

Santiago, Region M. de Santiago, Chile

Oncocentro ( Site 1065)

Viña del Mar, Valparaiso, Chile

Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 4034)

Hefei, Anhui, China

Beijing Cancer Hospital ( Site 4048)

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital ( Site 4036)

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital ( Site 4040)

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xiamen University ( Site 4060)

Xiamen, Fujian, China

The First Affiliated Hospital ( Site 4043)

Guangzhou, Guangdong, China

Guangxi Medical University Affiliated Tumor Hospital ( Site 4049)

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital ( Site 4033)

Harbin, Heilongjiang, China

Hubei Cancer Hospital ( Site 4059)

Wuhan, Hubei, China

Hunan Cancer Hospital ( Site 4050)

Changsha, Hunan, China

Xiangya Hospital Central South University ( Site 4035)

Changsha, Hunan, China

Nanjing Drum Tower Hospital ( Site 4037)

Nanjing, Jiangsu, China

Jiangxi Maternal and Child Health Hospital ( Site 4051)

Nanchang, Jiangxi, China

The First Hospital of Jilin University ( Site 4057)

Changchun, Jilin, China

The First Affiliated Hospital of Xi an Jiaotong University ( Site 4045)

Xi'an, Shaanxi, China

Obstetrics and Gynecology Hosp. Fudan University ( Site 4041)

Shanghai, Shanghai Municipality, China

Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053)

Shanghai, Shanghai Municipality, China

Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001)

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital. ( Site 4039)

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital ( Site 4054)

Tianjin, Tianjin Municipality, China

Yunnan Province Cancer Hospital-Gynecology Department ( Site 4055)

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University-Gynecology ( Site 4002)

Hangzhou, Zhejiang, China

Women s Hospital School of Medicine Zhejiang University ( Site 4032)

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University ( Site 4056)

Wenzhou, Zhejiang, China

Fundacion Colombiana de Cancerología Clinica Vida ( Site 1096)

Medellín, Antioquia, Colombia

Instituto Nacional de Cancerología E.S.E ( Site 1094)

Bogotá, Bogota D.C., Colombia

Instituto Cancerologico de Nariño S.A.S. ( Site 1092)

Pasto, Departamento de Nariño, Colombia

Fundación Valle del Lili ( Site 1093)

Cali, Valle del Cauca Department, Colombia

Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394)

Brno, Brno-mesto, Czechia

Fakultni nemocnice Kralovske Vinohrady ( Site 2393)

Prague, Praha 10, Czechia

Vseobecna fakultni nemocnice v Praze ( Site 2391)

Prague, Praha 2, Czechia

Fakultni nemocnice Olomouc ( Site 2392)

Olomouc, Czechia

Rigshospitalet University Hospital ( Site 2515)

Copehagen, Capital Region, Denmark

Herlev Hospital ( Site 2514)

Herlev, Capital Region, Denmark

Aalborg Universitetshospital ( Site 2511)

Aalborg, North Denmark, Denmark

Roskilde Sygehus ( Site 2513)

Roskilde, Region Sjælland, Denmark

Odense Universitetshospital ( Site 2512)

Odense, Region Syddanmark, Denmark

Kuopio University Hospital ( Site 2543)

Kuopio, Northern Savonia, Finland

Tampere University Hospital ( Site 2541)

Tampere, Pirkanmaa, Finland

And 131 more locations on ClinicalTrials.gov

Clinical Research Directory

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (231)