Clinical trial NCT04221945: Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)
Official title: A Randomized, Phase 3, Double-Blind Study of Chemoradiotherapy With or Without Pembrolizumab for the Treatment of High-risk, Locally Advanced Cervical Cancer (KEYNOTE-A18/ENGOT-cx11/GOG-3047)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Uterine Cervical Neoplasms
Keywords: Programmed Cell Death Receptor 1 (PD-1, PD1)
Programmed Cell Death Receptor Ligand 1 (PD-L1, PDL1)
Programmed Cell Death Receptor Ligand 2 (PD-L2, PDL2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: GOG Foundation
name: European Network of Gynaecological Oncological Trial Groups (ENGOT)
First posted: 2020-01-09
Enrollment: 1060
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer.

The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival.

Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.


Eligibility criteria: Inclusion Criteria:

* Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2014 Stage IB2-IIB (with node-positive disease) or FIGO 2014 Stages III-IVA
* Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix
* Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer, including investigational agents, and is immunotherapy-naïve
* Female participants must not be pregnant or breastfeeding and agree to use highly effective contraception during the treatment period and for at least 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
* Female participants must abstain from breastfeeding during the study intervention period and for at least 120 days after the last dose of pembrolizumab or placebo and 180 days following the end of chemoradiotherapy
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to the first dose of study treatment
* Has provided a tissue sample from a core incisional or excisional biopsy of a tumor lesion
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the local site investigator/radiology
* Has adequate organ function within 7 days prior to the start of study treatment.

Exclusion Criteria:

* Has excluded subtypes of LACC
* Has FIGO 2014 Stage IVB disease
* Has undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy
* Has bilateral hydronephrosis, unless at least one side has been stented or resolved by positioning of nephrostomy or considered mild and not clinically significant in the opinion of the investigator
* Has anatomy or tumor geometry or any other reason or contraindication that cannot be treated with intracavitary brachytherapy or a combination of intracavitary and interstitial brachytherapy
* Has received a live vaccine within 30 days prior to the first dose of study treatment
* Has received treatment with systemic immunostimulatory agents, colony stimulating factors, interferons, interleukins and vaccine combinations within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1
* 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 prior systemic anticancer therapy including investigational agents within 4 weeks prior to randomization
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
* Has any contraindication to the use of cisplatin
* 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 to the first dose of study treatment
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has severe hypersensitivity to pembrolizumab and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* Has a known history of Human Immunodeficiency Virus (HIV) infection
* Has a known history of Hepatitis B or known active Hepatitis C virus infection
* Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results, and in the judgment of the investigator or Sponsor, would make the participant inappropriate for entry into this study
* 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 evidence of metastatic disease per RECIST 1.1 including lymph nodes above the first lumbar vertebra (L1) cephalad body, in the inguinal region

Primary outcomes:
measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
timeFrame: Up to approximately 38 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 46 months
Secondary outcomes:
measure: 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)
timeFrame: Up to approximately 38 months
measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by the Investigator
timeFrame: Up to approximately 38 months
measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) at Month 24 as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 38 months
measure: Overall Survival (OS) at Month 36
timeFrame: Up to approximately 46 months
measure: Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) at Week 12 as Assessed by the Investigator
timeFrame: Up to approximately 38 months
measure: Complete Response (CR) Rate Per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) at Week 12 as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 38 months
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator
timeFrame: Up to approximately 46 months
measure: Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 46 months
measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator
timeFrame: Up to approximately 38 months
measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 38 months
measure: Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator
timeFrame: Up to approximately 46 months
measure: Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 46 months
measure: Progression-Free Survival (PFS) After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment
timeFrame: Up to approximately 46 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score
timeFrame: Baseline and up to approximately 46 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score
timeFrame: Baseline and up to approximately 46 months
measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score
timeFrame: Baseline and up to approximately 46 months
measure: Number of Participants Who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 46 months
measure: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 46 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HonorHealth Research Institute - Biltmore ( Site 8009)
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027)
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian ( Site 0038)
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center ( Site 0017)
state: California
city: Denver
country: United States
facility: University of Colorado Health Sciences Center and Hospital ( Site 0028)
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Center at Yale-New Haven ( Site 0023)
state: Connecticut
city: Orlando
country: United States
facility: AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009)
state: Florida
city: Fort Wayne
country: United States
facility: Parkview Research Center at Parkview Regional Medical Center ( Site 0026)
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Markey Cancer Center ( Site 0015)
state: Kentucky
city: Baton Rouge
country: United States
facility: Our Lady of the Lake Regional Medical Center. ( Site 0031)
state: Louisiana
city: Covington
country: United States
facility: Women's Cancer Care ( Site 0039)
state: Louisiana
city: Detroit
country: United States
facility: Karmanos Cancer Institute ( Site 0018)
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA ( Site 8007)
state: Minnesota
city: Albuquerque
country: United States
facility: University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019)
state: New Mexico
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill ( Site 0025)
state: North Carolina
city: Bismarck
country: United States
facility: Sanford Bismarck Medical Center ( Site 0046)
state: North Dakota
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer Institute and Research Center ( Site 8000)
state: Oregon
city: Portland
country: United States
facility: Legacy Good Samaritan Medical Center ( Site 0013)
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030)
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center ( Site 0007)
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Gynecology Oncology ( Site 0003)
state: South Dakota
city: Austin
country: United States
facility: Texas Oncology-Austin Central ( Site 8006)
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology-Fort Worth Cancer Center ( Site 8001)
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio Medical Center ( Site 8002)
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology-The Woodlands ( Site 8003)
state: Texas
city: Charlottesville
country: United States
facility: UVA Health System ( Site 0005)
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University ( Site 0024)
state: Virginia
city: Westmead
country: Australia
facility: Westmead Hospital ( Site 0973)
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women s Hospital ( Site 0972)
state: Queensland
city: Clayton
country: Australia
facility: Monash Health-Monash Medical Centre ( Site 0970)
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre ( Site 0971)
state: Victoria
city: Subiaco
country: Australia
facility: St John of God Subiaco Hospital ( Site 0969)
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universitat Graz ( Site 0569)
state: Steiermark
city: Innsbruck
country: Austria
facility: Medizinische Universitat Innsbruck ( Site 0566)
state: Tirol
city: Vienna
country: Austria
facility: Medizinische Universität Wien ( Site 0567)
state: Wien
city: Edegem
country: Belgium
facility: UZA University Hospital Antwerp ( Site 0351)
state: Antwerpen
city: Wilrijk
country: Belgium
facility: GZA Sint Augustinus ( Site 0356)
state: Antwerpen
city: Mons
country: Belgium
facility: C.I.U. Hopital Ambroise Pare ( Site 0353)
state: Hainaut
city: Aalst
country: Belgium
facility: OLV Ziekenhuis ( Site 0352)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: AZ St Lucas ( Site 0349)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 0354)
state: Vlaams-Brabant
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas da UFMG ( Site 0172)
state: Minas Gerais
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 0170)
state: Rio Grande Do Norte
city: Ribeirão Preto
country: Brazil
facility: Hospital de Clínicas de Ribeirão Preto ( Site 0171)
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional Do Cancer II ( Site 0173)
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0102)
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101)
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0105)
state: Quebec
city: Quebec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
state: Quebec
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0194)
state: Araucania
city: Santiago
country: Chile
facility: Sociedad Oncovida S.A. ( Site 0196)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Iram Cancer Research ( Site 0198)
state: Region M. De Santiago
city: Vina del Mar
country: Chile
facility: Oncocentro ( Site 0195)
state: Valparaiso
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 1029)
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital ( Site 1007)
state: Anhui
city: Beijing
country: China
facility: Peking Union Medical College Hospital ( Site 1001)
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital ( Site 1030)
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 1025)
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital.Sun Yat-sen University ( Site 1005)
state: Guangdong
city: Nanning
country: China
facility: Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036)
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 1013)
state: Heilongjiang
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 1015)
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central-South University ( Site 1009)
state: Hunan
city: Shanghai
country: China
facility: Shanghai Cancer Hospital ( Site 1000)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039)
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Cancer Hospital ( Site 1018)
state: Sichuan
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University ( Site 1012)
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital ( Site 1021)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 1004)
state: Zhejiang
city: Medellin
country: Colombia
facility: Fundacion Centro de Investigacion Clinica CIC ( Site 0231)
state: Antioquia
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia E.S.E ( Site 0228)
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Fundacion Valle del Lili ( Site 0230)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 0227)
state: Valle Del Cauca
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno Bohunice ( Site 0912)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava ( Site 0909)
state: Moravskoslezsky Kraj
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady ( Site 0913)
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0411)
state: Doubs
city: Toulouse
country: France
facility: Institut Claudius Regaud ( Site 0417)
state: Haute-Garonne
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud ( Site 0413)
state: Rhone
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg ( Site 0454)
state: Baden-Wurttemberg
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443)
state: Baden-Wurttemberg
city: Muenchen
country: Germany
facility: Klinikum der Universitaet in Muenchen ( Site 0446)
state: Bayern
city: Muenchen
country: Germany
facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453)
state: Bayern
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452)
state: Sachsen
city: Leipzig
country: Germany
facility: Universitaetsklinik Leipzig ( Site 0456)
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin ( Site 0442)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0445)
city: Patras
country: Greece
facility: General Hospital of Patras. St Andrews ( Site 0473)
state: Achaia
city: Athens
country: Greece
facility: Alexandra General Hospital ( Site 0477)
state: Attiki
city: Athens
country: Greece
facility: Hospital Hygeia ( Site 0478)
state: Attiki
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic of Thessaloniki ( Site 0474)
city: Guatemala
country: Guatemala
facility: Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321)
city: Guatemala
country: Guatemala
facility: Oncologika S.A. ( Site 0323)
city: Guatemala
country: Guatemala
facility: Oncomedica ( Site 0320)
city: Guatemala
country: Guatemala
facility: Grupo Angeles SA ( Site 0319)
city: Guatemala
country: Guatemala
facility: Medi-K Cayala ( Site 0318)
city: Quetzaltenango
country: Guatemala
facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 0322)
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 0846)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 0845)
city: Cork
country: Ireland
facility: Cork University Hospital ( Site 0504)
city: Dublin
country: Ireland
facility: St James Hospital ( Site 0505)
city: Haifa
country: Israel
facility: Rambam Medical Center ( Site 0815)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center. Ein Kerem ( Site 0816)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 0814)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0819)
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia ( Site 0536)
state: Milano
city: Candiolo
country: Italy
facility: Istituto di Candiolo - IRCCS ( Site 0546)
state: Piemonte
city: Rome
country: Italy
facility: Istituto Nazionale Tumori Regina Elena ( Site 0540)
state: Roma
city: Bologna
country: Italy
facility: A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541)
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi ( Site 0547)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele ( Site 0539)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542)
city: Napoli
country: Italy
facility: Fondazione Giovanni Pascale Di Napoli ( Site 0544)
city: Roma
country: Italy
facility: Policlinico Universitario Gemelli ( Site 0538)
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 1155)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 1159)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 1162)
state: Ehime
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1157)
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital ( Site 1164)
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 1163)
state: Hokkaido
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital ( Site 1165)
state: Iwate
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital ( Site 1156)
state: Okinawa
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 1168)
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center ( Site 1169)
state: Saitama
city: Mitaka
country: Japan
facility: Kyorin University Hospital ( Site 1158)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 1167)
city: Kagoshima
country: Japan
facility: Kagoshima City Hospital ( Site 1166)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 1161)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 1172)
city: Tokyo
country: Japan
facility: Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 1170)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 1065)
state: Kyonggi-do
city: Seoul.
country: Korea, Republic of
facility: Asan Medical Center ( Site 1062)
state: Seoul
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center ( Site 1066)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Severance Hospital ( Site 1063)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 1064)
city: Bergen
country: Norway
facility: Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601)
state: Hordaland
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0600)
city: Arequipa
country: Peru
facility: Centro Medico Monte Carmelo ( Site 0289)
state: Ariqipa
city: Trujillo
country: Peru
facility: Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287)
state: La Libertad
city: Callao
country: Peru
facility: Hospital Nacional Daniel Alcides Carrion ( Site 0293)
state: Lima
city: San Miguel
country: Peru
facility: Clinica San Gabriel ( Site 0296)
state: Lima
city: Lima
country: Peru
facility: Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290)
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza ( Site 0292)
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291)
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741)
state: Chelyabinskaya Oblast
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729)
state: Krasnoyarskiy Kray
city: Moscow
country: Russian Federation
facility: MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: GBUZ SPb CRPCstmc(o) ( Site 0746)
state: Sankt-Peterburg
city: St. Petersburg
country: Russian Federation
facility: National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725)
state: Sankt-Peterburg
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734)
state: Yaroslavskaya Oblast
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637)
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Hosp Clin Univ de Santiago ( Site 0629)
state: La Coruna
city: Pozuelo de Alarcon
country: Spain
facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638)
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d Hebron ( Site 0634)
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen ( Site 0632)
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa ( Site 0630)
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset ( Site 0784)
state: Stockholms Lan
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1095)
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital ( Site 1094)
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital ( Site 1097)
city: Mueang
country: Thailand
facility: Srinagarind Hospital. Khon Kaen University ( Site 1132)
state: Khon Kaen
city: Rajthevee
country: Thailand
facility: Ramathibodi Hospital, Mahidol University ( Site 1131)
state: Krung Thep Maha Nakhon
city: Hatyai
country: Thailand
facility: Songklanagarind Hospital ( Site 1130)
state: Songkhla
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital ( Site 1133)
city: Istambul
country: Turkey
facility: I.U. Cerrahpasa Medical Faculty ( Site 0755)
state: Istanbul
city: Adana
country: Turkey
facility: Acibadem Adana Hastanesi ( Site 0756)
city: Ankara
country: Turkey
facility: Baskent Universitesi Ankara Hastanesi ( Site 0754)
city: Kharkiv
country: Ukraine
facility: Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876)
state: Kharkivska Oblast
city: Lviv
country: Ukraine
facility: Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882)
state: Lvivska Oblast
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Foundation Trust Hospital ( Site 0699)
state: England
city: London
country: United Kingdom
facility: ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696)
state: Surrey
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Sukhin V, Cloven N, Pereira de Santana Gomes AJ, Contreras Mejia F, Reiss A, Ayhan A, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Lazzari R, Chang CL, Lampe R, Zhu H, Oaknin A, Christiaens M, Polterauer S, Usami T, Li K, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): a randomised, double-blind, phase 3 clinical trial. Lancet. 2024 Apr 6;403(10434):1341-1350. doi: 10.1016/S0140-6736(24)00317-9. Epub 2024 Mar 20.
citation: Lorusso D, Xiang Y, Hasegawa K, Scambia G, Leiva M, Ramos-Elias P, Acevedo A, Cvek J, Randall L, Pereira de Santana Gomes AJ, Contreras Mejia F, Helpman L, Akilli H, Lee JY, Saevets V, Zagouri F, Gilbert L, Sehouli J, Tharavichitkul E, Lindemann K, Colombo N, Chang CL, Bednarikova M, Zhu H, Oaknin A, Christiaens M, Petru E, Usami T, Liu P, Yamada K, Toker S, Keefe SM, Pignata S, Duska LR; ENGOT-cx11/GOG-3047/KEYNOTE-A18 investigators. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2024 Oct 5;404(10460):1321-1332. doi: 10.1016/S0140-6736(24)01808-7. Epub 2024 Sep 14.