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)

Endometrial Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04634877
• Other study ID #: 3475-B21
• Secondary ID: KEYNOTE-B21ENGOT
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 10, 2021
• Est. completion date: June 18, 2025

Study information

• Verified date: November 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 990
• Est. completion date: June 18, 2025
• Est. primary completion date: June 18, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Biological:
• Pembrolizumab
IV infusion

Drug:
• Carboplatin
IV infusion
• Paclitaxel
IV infusion
• Placebo for pembrolizumab
IV infusion
• 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.
• 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

Locations

Country	Name	City	State
Argentina	Centro de Oncología e Investigación de Buenos Aires ( Site 1005)	Berazategui	Buenos Aires
Argentina	CEMIC ( Site 1009)	Buenos Aires
Argentina	Hospital Aleman ( Site 1001)	Buenos Aires
Argentina	Hospital Britanico de Buenos Aires ( Site 1002)	Buenos Aires	Caba
Argentina	IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010)	Buenos Aires
Argentina	IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006)	Caba	Buenos Aires
Argentina	Centro Oncologico Riojano Integral ( Site 1007)	La Rioja
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
Austria	Medizinische Universitat Graz ( Site 2004)	Graz	Steiermark
Austria	Medizinische Universitaet Innsbruck ( Site 2001)	Innsbruck	Tirol
Belgium	OLV Ziekenhuis ( Site 2038)	Aalst	Oost-Vlaanderen
Belgium	Saint-Luc UCL ( Site 2042)	Bruxelles	Bruxelles-Capitale, Region De
Belgium	AZ Maria Middelares Gent ( Site 2032)	Gent	Oost-Vlaanderen
Belgium	Universitair Ziekenhuis Gent ( Site 2037)	Gent	Oost-Vlaanderen
Belgium	AZ Groeninge ( Site 2036)	Kortrijk	West-Vlaanderen
Belgium	UZ Leuven ( Site 2040)	Leuven	Vlaams-Brabant
Belgium	CHC - Groupe Sante ( Site 2041)	Liege
Belgium	CHU Liege Sart-Tilman ( Site 2044)	Liege
Belgium	C.I.U. Hopital Ambroise Pare ( Site 2039)	Mons	Hainaut
Belgium	AZ Nikolaas ( Site 2031)	Sint-Niklaas	Oost-Vlaanderen
Belgium	CHR Verviers ( Site 2035)	Verviers	Liege
Canada	Tom Baker 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 3	Quebec City	Quebec
Chile	Bradfordhill-Clinical Area ( Site 1070)	Santiago	Region M. De Santiago
Chile	Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063)	Santiago	Region M. De Santiago
Chile	Fundacion Arturo Lopez Perez FALP ( Site 1062)	Santiago	Region M. De Santiago
Chile	Centro Investigación del Cáncer James Lind ( Site 1061)	Temuco	Araucania
Chile	Oncocentro ( Site 1065)	Vina del Mar	Valparaiso
China	Beijing Cancer Hospital ( Site 4048)	Beijing	Beijing
China	Peking Union Medical College Hospital ( Site 4036)	Beijing	Beijing
China	The First Bethune Hospital of Jilin University ( Site 4057)	Changchun	Jilin
China	Hunan Cancer Hospital ( Site 4050)	Changsha	Hunan
China	Xiangya Hospital Central-South University ( Site 4035)	Changsha	Hunan
China	Sichuan Cancer Hospital ( Site 4039)	Chengdu	Sichuan
China	Chongqing Cancer Hospital ( Site 4040)	Chongqing	Chongqing
China	The First Affiliated Hospital ( Site 4043)	Guangzhou	Guangdong
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	Harbin Medical University Cancer Hospital ( Site 4033)	Harbin	Heilongjiang
China	Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 4034)	Hefei	Anhui
China	Yunnan Province Cancer Hospital-Gynecology Department ( Site 4055)	Kunming	Yunnan
China	Jiangxi Maternal and Child Health Hospital ( Site 4051)	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital ( Site 4037)	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital ( Site 4049)	Nanning	Guangxi
China	Obstetrics and Gynecology Hosp. Fudan University ( Site 4041)	Shanghai	Shanghai
China	Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001)	Shanghai	Shanghai
China	Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053)	Shanghai	Shanghai
China	Tianjin Medical University Cancer Institute & Hospital ( Site 4054)	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University ( Site 4056)	Wenzhou	Zhejiang
China	Hubei Cancer Hospital ( Site 4059)	Wuhan	Hubei
China	The First Affiliated Hospital of Xi an Jiaotong University ( Site 4045)	XI An	Shaanxi
China	The First Affiliated Hospital of Xiamen University ( Site 4060)	Xiamen	Fujian
Colombia	Instituto Nacional de Cancerología E.S.E ( Site 1094)	Bogota	Distrito Capital De Bogota
Colombia	Fundacion Valle del Lili ( Site 1093)	Cali	Valle Del Cauca
Colombia	Clínica Vida Fundación - Sede Poblado ( Site 1096)	Medellin	Antioquia
Colombia	Instituto Cancerologico de Narino Ltda ( Site 1092)	San Juan De Pasto	Narino
Czechia	Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394)	Brno	Brno-mesto
Czechia	Fakultni nemocnice Olomouc ( Site 2392)	Olomouc
Czechia	Fakultni nemocnice Kralovske Vinohrady ( Site 2393)	Praha	Praha 10
Czechia	Vseobecna fakultni nemocnice v Praze ( Site 2391)	Praha	Praha 2
Denmark	Aalborg Universitetshospital ( Site 2511)	Aalborg	Nordjylland
Denmark	Rigshospitalet University Hospital ( Site 2515)	Copehagen	Hovedstaden
Denmark	Herlev Hospital ( Site 2514)	Herlev	Hovedstaden
Denmark	Odense Universitetshospital ( Site 2512)	Odense	Syddanmark
Denmark	Roskilde Sygehus ( Site 2513)	Roskilde	Sjaelland
Finland	Kuopio University Hospital ( Site 2543)	Kuopio	Pohjois-Savo
Finland	Tampere University Hospital ( Site 2541)	Tampere	Pirkanmaa
Finland	Turku University Hospital ( Site 2542)	Turku	Varsinais-Suomi
France	CHU Besancon - Hopital Jean Minjoz ( Site 2068)	Besancon	Doubs
France	Institut Bergonie ( Site 2067)	Bordeaux	Gironde
France	Centre Francois Baclesse ( Site 2062)	Caen	Calvados
France	Institut Regional du Cancer de Montpellier - ICM ( Site 2069)	Montpellier	Herault
France	Hopital prive du Confluent ( Site 2061)	Nantes	Loire-Atlantique
France	Centre Antoine Lacassagne ( Site 2073)	Nice	Alpes-Maritimes
France	Hopital Cochin ( Site 2070)	Paris	Ile-de-France
France	Centre Hospitalier Lyon Sud ( Site 2064)	Pierre Benite	Rhone
France	Hôpital Privé Des Côtes d'Armor ( Site 2063)	Plérin	Cotes-d Armor
France	Institut Universitaire du Cancer Toulouse - Oncopole ( Site 2065)	Toulouse	Haute-Garonne
France	Institut De Cancerologie De Lorraine ( Site 2072)	Vandoeuvre les Nancy	Ain
France	Gustave Roussy ( Site 2071)	Villejuif	Ile-de-France
Germany	Universitätsklinikum Bonn-Gynaecological oncology ( Site 2103)	Bonn	Nordrhein-Westfalen
Germany	Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur	Dresden	Sachsen
Germany	Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2105)	Essen	Nordrhein-Westfalen
Germany	Medizinische Hochschule Hannover-Department of Obstetrics and Gynecology ( Site 2109)	Hannover	Niedersachsen
Germany	SLK-Kliniken Heilbronn GmbH ( Site 2116)	Heilbronn	Baden-Wurttemberg
Germany	Universitätsklinikum Schleswig-Holstein ( Site 2101)	Lübeck	Schleswig-Holstein
Germany	Klinikum Ludwigsburg ( Site 2111)	Ludwigsburg	Baden-Wurttemberg
Germany	Universitaetsklinikum Tuebingen ( Site 2113)	Tübingen	Baden-Wurttemberg
Greece	Geniko Panepistimako Nosokomeio ARETEIO ( Site 2423)	Athens	Attiki
Greece	Perifereiako Geniko Nosokomeio ALEXANDRA ( Site 2425)	Athens	Attiki
Greece	Athens University Hospital ATTIKON ( Site 2424)	Chaidari	Attiki
Greece	Hospital Hygeia ( Site 2426)	Marousi	Attiki
Greece	General Hospital of Patras. St Andrews ( Site 2421)	Patras	Achaia
Greece	Euromedica General Clinic of Thessaloniki ( Site 2422)	Thessaloniki
Israel	Rambam Medical Center ( Site 2307)	Haifa
Israel	Edith Wolfson Medical Center ( Site 2306)	Holon
Israel	Hadassah Medical Center. Ein Kerem ( Site 2303)	Jerusalem
Israel	Rabin Medical Center ( Site 2305)	Petah Tikva
Israel	Chaim Sheba Medical Center ( Site 2301)	Ramat Gan
Italy	Azienda Ospedaliera Spedali Civili di Brescia ( Site 2135)	Brescia
Italy	Istituto di Candiolo - IRCCS ( Site 2125)	Candiolo	Piemonte
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2122)	Milano
Italy	IRCCS Ospedale San Raffaele ( Site 2130)	Milano
Italy	Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 2132)	Milano
Italy	Azienda Ospedaliera Universitaria Federico II ( Site 2123)	Napoli
Italy	Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2127)	Napoli
Italy	Istituto Oncologico Veneto IRCCS-Oncologia 2 ( Site 2134)	Padova
Italy	Fondazione Policlinico Universitario Agostino Gemelli ( Site 2124)	Roma	Lazio
Italy	Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 2121)	Roma	Abruzzo
Japan	Hyogo Cancer Center ( Site 4195)	Akashi	Hyogo
Japan	National Hospital Organization Kyushu Cancer Center ( Site 4193)	Fukuoka
Japan	Saitama Medical University International Medical Center ( Site 4182)	Hidaka	Saitama
Japan	National Cancer Center Hospital East ( Site 4197)	Kashiwa	Chiba
Japan	Kurume University Hospital ( Site 4186)	Kurume	Fukuoka
Japan	National Hospital Organization Shikoku Cancer Center ( Site 4181)	Matsuyama	Ehime
Japan	Aichi Cancer Center Hospital ( Site 4190)	Nagoya	Aichi
Japan	University of the Ryukyus Hospital ( Site 4184)	Nakagami-gun	Okinawa
Japan	Niigata Cancer Center Hospital ( Site 4185)	Niigata
Japan	Osaka International Cancer Institute ( Site 4188)	Osaka
Japan	Gunma Prefectural Cancer Center ( Site 4183)	Ota	Gunma
Japan	Hokkaido University Hospital ( Site 4194)	Sapporo	Hokkaido
Japan	Iwate Medical University Hospital ( Site 4189)	Shiwa-gun	Iwate
Japan	Shizuoka Cancer Center Hospital and Research Institute ( Site 4192)	Sunto-gun	Shizuoka
Japan	Keio University Hospital ( Site 4191)	Tokyo
Japan	The Cancer Institute Hospital of JFCR ( Site 4196)	Tokyo
Japan	Ehime University Hospital ( Site 4187)	Toon	Ehime
Korea, Republic of	National Cancer Center ( Site 4065)	Goyang-si	Kyonggi-do
Korea, Republic of	Seoul National University Bundang Hospital ( Site 4063)	Seongnam-si	Kyonggi-do
Korea, Republic of	Asan Medical Center ( Site 4061)	Seoul
Korea, Republic of	Samsung Medical Center ( Site 4064)	Seoul
Korea, Republic of	Severance Hospital Yonsei University Health System ( Site 4062)	Seoul
Mexico	Instituto Nacional de Cancerologia ( Site 1124)	Cdmx	Distrito Federal
Mexico	Hospital Angeles Roma ( Site 1123)	Ciudad de Mexico
Mexico	Investigacion Onco Farmaceutica S de RL de CV ( Site 1127)	La Paz	Baja California Sur
Mexico	Centro Oncologico Internacional. SEDNA ( Site 1121)	Mexico City
Mexico	Christus Muguerza Clinica Vidriera ( Site 1125)	Monterrey	Nuevo Leon
Mexico	I Can Oncology Center SA de CV ( Site 1126)	Monterrey	Nuevo Leon
Mexico	Hospital San Lucas Cardiologica del Sureste ( Site 1122)	Tuxtla Gutierrez	Chiapas
Norway	Soerlandet sykehus HF Kristiansand ( Site 2152)	Kristiansand	Vest-Agder
Norway	Oslo Universitetssykehus Radiumhospitalet ( Site 2151)	Oslo
Norway	University Hospital of North Norway ( Site 2153)	Tromso	Troms
Poland	Bialostockie Centrum Onkologii ( Site 2483)	Bialystok	Podlaskie
Poland	Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2482)	Gliwice	Slaskie
Poland	Swietokrzyskie Centrum Onkologii SPZOZ ( Site 2485)	Kielce	Swietokrzyskie
Poland	SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2486)	Olsztyn	Warminsko-mazurskie
Poland	Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 2484)	Poznan	Wielkopolskie
Poland	Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2487)	Siedlce	Mazowieckie
Poland	Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2481)	Warszawa	Mazowieckie
Russian Federation	Arkhangelsk Clinical Oncological Dispensary ( Site 2637)	Arkhangelsk	Arkhangel Skaya Oblast
Russian Federation	Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 2644)	Chelyabinsk	Chelyabinskaya Oblast
Russian Federation	Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2646)	Kazan	Tatarstan, Respublika
Russian Federation	Krasnoyarsk Regional Clinical oncology dispensary ( Site 2643)	Krasnoyarsk	Krasnoyarskiy Kray
Russian Federation	FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 2634)	Moscow	Moskva
Russian Federation	Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2631)	Moscow	Moskva
Russian Federation	Nizhegorodsky Regional Oncology Dispensary-chemotherapy department (Branch?1) ( Site 2639)	Nizhniy Novgorod	Nizhegorodskaya Oblast
Russian Federation	Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2636)	Saint-Petersburg	Sankt-Peterburg
Russian Federation	Samara Regional Clinical Oncology Center-Chemotherapy Dapartment ( Site 2649)	Samara	Samarskaya Oblast
Russian Federation	National Research Ogarev Mordovia State University ( Site 2648)	Saransk	Mordoviya, Respublika
Russian Federation	Tomsk Scientific Research Institute of Oncology-Chemotherapy ( Site 2638)	Tomsk	Tomskaya Oblast
Russian Federation	Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 2645)	Ufa	Baskortostan, Respublika
Russian Federation	Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2641)	Yaroslavl	Yaroslavskaya Oblast
Spain	Hospital Clinic i Provincial ( Site 2185)	Barcelona
Spain	Hospital Vall D Hebron ( Site 2182)	Barcelona
Spain	Hospital Universitario Reina Sofia ( Site 2183)	Cordoba
Spain	Hospital Josep Trueta ( Site 2184)	Girona	Gerona
Spain	Clinica Universitaria de Navarra ( Site 2181)	Madrid	Madrid, Comunidad De
Spain	Hospital Clinico San Carlos ( Site 2187)	Madrid
Spain	Hospital Universitario La Paz ( Site 2186)	Madrid
Sweden	Universitetssjukhuset i Linkoping. ( Site 2222)	Linkoping	Ostergotlands Lan
Sweden	Karolinska Universitetssjukhuset Solna ( Site 2220)	Solna	Stockholms Lan
Sweden	Blod-och Tumorsjukdomar ( Site 2221)	Uppsala	Uppsala Lan
Taiwan	Changhua Christian Hospital ( Site 4095)	Changhua
Taiwan	Taichung Veterans General Hospital ( Site 4094)	Taichung
Taiwan	MacKay Memorial Hospital ( Site 4092)	Taipei
Taiwan	Taipei Veterans General Hospital ( Site 4093)	Taipei
Taiwan	Linkou Chang Gung Memorial Hospital ( Site 4091)	Taoyuan
Turkey	Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2355)	Adana
Turkey	Cukurova Uni. Tip Fakultesi ( Site 2353)	Adana
Turkey	Ankara Universitesi Tip Fakultesi Hastanesi ( Site 2350)	Ankara
Turkey	Baskent Universitesi Ankara Hastanesi ( Site 2354)	Ankara
Turkey	Medipol Universite Hastanesi ( Site 2352)	Istanbul
Turkey	Ege University Medical Faculty ( Site 2351)	Izmir
Turkey	I.E.U. Medical Point Hastanesi ( Site 2356)	Izmir
Ukraine	Chernihiv Medical Center of Modern Oncology ( Site 2368)	Chernihiv	Chernihivska Oblast
Ukraine	Municipal Enterprise "Bukovinian ?linical oncology ?enter" ( Site 2366)	Chernivtsi	Chernivetska Oblast
Ukraine	SO Grigoriev Institute for Medical Radiology and Oncology of NAMS of Ukraine ( Site 2363)	Kharkiv	Kharkivska Oblast
Ukraine	MNE "Khmelnytskyi regional antitumor center" ( Site 2365)	Khmelnitskyi	Khmelnytska Oblast
Ukraine	LISOD - Israeli Oncological Hospital MedX-ray International Group, LLC ( Site 2364)	Kiev	Kyivska Oblast
Ukraine	The Municipal Enterprise Volyn Regional Medical Oncology Centre ( Site 2362)	Lutsk	Volynska Oblast
Ukraine	Lviv State Regional Oncological Center ( Site 2361)	Lviv	Lvivska Oblast
United Kingdom	Bristol Haematology and Oncology Centre ( Site 2244)	Bristol	Bristol, City Of
United Kingdom	Castle Hill Hospital-Academic Oncology ( Site 2252)	Cottingham	East Riding Of Yorkshire
United Kingdom	Beatson West of Scotland Cancer Centre ( Site 2247)	Glasgow	Glasgow City
United Kingdom	Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 2249)	Leicester
United Kingdom	Royal Marsden NHS Foundation Trust ( Site 2248)	London	London, City Of
United Kingdom	UCLH NHS Foundation Trust ( Site 2242)	London	London, City Of
United Kingdom	The Christie Hospital NHS Foundation Trust ( Site 2243)	Manchester
United Kingdom	Royal Marsden Hospital Sutton-Surrey ( Site 2241)	Sutton	London, City Of
United States	Northside Hospital ( Site 3036)	Atlanta	Georgia
United States	University Of Colorado ( Site 3051)	Aurora	Colorado
United States	University of Alabama - Birmingham ( Site 3061)	Birmingham	Alabama
United States	Montefiore Medical Center ( Site 3065)	Bronx	New York
United States	Northwestern Memorial Hospital ( Site 3044)	Chicago	Illinois
United States	The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C	Columbus	Ohio
United States	UT Southwestern Medical Center ( Site 3063)	Dallas	Texas
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	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	UCSD Moores Cancer Center ( Site 3053)	La Jolla	California
United States	Norton Cancer Institute - St. Matthews ( Site 3056)	Louisville	Kentucky
United States	Mount Sinai Cancer Center ( Site 3081)	Miami Beach	Florida
United States	Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076)	Mineola	New York
United States	University of South Alabama, Mitchell Cancer Institute ( Site 3058)	Mobile	Alabama
United States	Smilow Cancer Hospital at Yale New Haven ( Site 3070)	New Haven	Connecticut
United States	Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042)	New York	New York
United States	Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078)	Philadelphia	Pennsylvania
United States	HonorHealth Research Institute - Biltmore ( Site 3043)	Phoenix	Arizona
United States	AHN West Penn Hospital ( Site 3060)	Pittsburgh	Pennsylvania
United States	Legacy Good Samaritan Medical Center ( Site 3033)	Portland	Oregon
United States	VCU Massey Cancer Center ( Site 3068)	Richmond	Virginia
United States	WK Physicians Network/Gynecologic Oncology Associates ( Site 3047)	Shreveport	Louisiana
United States	Sanford Gynecology Oncology ( Site 3045)	Sioux Falls	South Dakota
United States	Arizona Oncology Associates PC- HOPE ( Site 3049)	Tucson	Arizona
United States	Abington Hospital - Asplundh Cancer Center ( Site 3073)	Willow Grove	Pennsylvania
United States	University of Massachusetts Medical School ( Site 3037)	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC	European Network for Gynaecological Oncological Trial Groups, Gynecologic Oncology Group

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Canada,  Chile,  China,  Colombia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Norway,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence	DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence, will be presented.	Up to approximately 42 months
Primary	Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	Up to approximately 54 months
Secondary	Disease-Free Survival (DFS) as Assessed Radiographically by Blinded Independent Central Review (BICR) or by Histopathologic Confirmation of Suspected Disease Recurrence	DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by BICR or by histopathologic confirmation of suspected disease recurrence, will be presented.	Up to approximately 42 months
Secondary	Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status	DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by CPS-determined PD-L1 status will be presented.	Up to approximately 42 months
Secondary	Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Combined Positivity Score (CPS)-Determined Programmed Cell Death 1 Ligand 1 (PD-L1) Status	OS is defined as the time from randomization to death due to any cause. The OS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by CPS-determined PD-L1 status will be presented.	Up to approximately 54 months
Secondary	Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status	DFS is defined as the time from randomization to the first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first. The DFS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by tumor mutation burden (TMB) status, will be presented.	Up to approximately 42 months
Secondary	Overall Survival (OS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence by Tumor Mutation Burden (TMB) Status	OS is defined as the time from randomization to death due to any cause. The OS as assessed radiographically by investigator or by histopathologic confirmation of suspected disease recurrence by tumor mutation burden (TMB) status will be presented.	Up to approximately 54 months
Secondary	Number of Participants Who Experience One or More Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.	Up to approximately 54 months
Secondary	Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.	Up to approximately 52 weeks
Secondary	Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Global Health Status/Quality of Life (QoL) Score	The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. Participant responses to questions 29 ("How would you rate your overall health during the past week?") and 30 ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). A higher score indicates a better overall health/quality of life status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.	Baseline and up to approximately 54 months
Secondary	Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Physical Function Score	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in physical function (EORTC QLQ-C30 Items 1-5) score will be presented.	Baseline and up to approximately 54 months
Secondary	Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Endometrial Cancer (EORTC QLQ-EN24) Score	The EORTC-QLQ-EN24 is a 24-item questionnaire developed to be used in conjunction with the EORTC-QLQ-C30 to assess the quality of life of endometrial cancer patients. Participant responses are scored on a 4-point scale (1=not at all to 4=very much). A higher score indicates a better quality of life. The change from baseline in EORTC QLQ-E24 score will be presented.	Baseline and up to approximately 54 months

External Links

•   Merck Clinical Trials Information
•   Plain Language Summary