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)
NCT ID: NCT04221945
Last Updated: 2026-01-05
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1060 participants
INTERVENTIONAL
2020-05-12
2026-01-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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chemoradiotherapy + pembrolizumab
Participants receive pembrolizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of pembrolizumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
Pembrolizumab
IV infusion
Cisplatin
IV infusion
External Beam Radiotherapy (EBRT)
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Brachytherapy
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
chemoradiotherapy + placebo for pembrolizumab
Participants receive placebo for pembrolizumab IV on Day 1 of each 3-week cycle (Q3W) for 5 cycles followed by placebo IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles. During the Q3W dosing period of placebo, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 5 or 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80 Gray Units (Gy) for volume-directed and 75 Gy for point-directed given with the total duration of radiation treatment not to exceed 50 days (with an extension to a maximum of 56 days for unforeseen delays).
Placebo for pembrolizumab
IV infusion
Cisplatin
IV infusion
External Beam Radiotherapy (EBRT)
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Brachytherapy
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Interventions
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Pembrolizumab
IV infusion
Placebo for pembrolizumab
IV infusion
Cisplatin
IV infusion
External Beam Radiotherapy (EBRT)
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Brachytherapy
Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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GOG Foundation
NETWORK
European Network of Gynaecological Oncological Trial Groups (ENGOT)
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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HonorHealth Research Institute - Biltmore ( Site 8009)
Phoenix, Arizona, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027)
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian ( Site 0038)
Newport Beach, California, United States
UC Davis Comprehensive Cancer Center ( Site 0017)
Sacramento, California, United States
University of Colorado Health Sciences Center and Hospital ( Site 0028)
Denver, Colorado, United States
Smilow Cancer Center at Yale-New Haven ( Site 0023)
New Haven, Connecticut, United States
AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009)
Orlando, Florida, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0026)
Fort Wayne, Indiana, United States
University of Kentucky Markey Cancer Center ( Site 0015)
Lexington, Kentucky, United States
Our Lady of the Lake Regional Medical Center. ( Site 0031)
Baton Rouge, Louisiana, United States
Women's Cancer Care ( Site 0039)
Covington, Louisiana, United States
Karmanos Cancer Institute ( Site 0018)
Detroit, Michigan, United States
Minnesota Oncology Hematology, PA ( Site 8007)
Minneapolis, Minnesota, United States
University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019)
Albuquerque, New Mexico, United States
University of North Carolina at Chapel Hill ( Site 0025)
Chapel Hill, North Carolina, United States
Sanford Bismarck Medical Center ( Site 0046)
Bismarck, North Dakota, United States
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
Columbus, Ohio, United States
Willamette Valley Cancer Institute and Research Center ( Site 8000)
Eugene, Oregon, United States
Legacy Good Samaritan Medical Center ( Site 0013)
Portland, Oregon, United States
Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030)
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center ( Site 0007)
Charleston, South Carolina, United States
Sanford Gynecology Oncology ( Site 0003)
Sioux Falls, South Dakota, United States
Texas Oncology-Austin Central ( Site 8006)
Austin, Texas, United States
Texas Oncology-Fort Worth Cancer Center ( Site 8001)
Fort Worth, Texas, United States
Texas Oncology-San Antonio Medical Center ( Site 8002)
San Antonio, Texas, United States
Texas Oncology-The Woodlands ( Site 8003)
The Woodlands, Texas, United States
UVA Health System ( Site 0005)
Charlottesville, Virginia, United States
Virginia Commonwealth University ( Site 0024)
Richmond, Virginia, United States
Westmead Hospital ( Site 0973)
Westmead, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 0972)
Herston, Queensland, Australia
Monash Health-Monash Medical Centre ( Site 0970)
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre ( Site 0971)
Melbourne, Victoria, Australia
St John of God Subiaco Hospital ( Site 0969)
Subiaco, Western Australia, Australia
Medizinische Universitat Graz ( Site 0569)
Graz, Styria, Austria
Medizinische Universitat Innsbruck ( Site 0566)
Innsbruck, Tyrol, Austria
Medizinische Universität Wien ( Site 0567)
Vienna, Vienna, Austria
UZA University Hospital Antwerp ( Site 0351)
Edegem, Antwerpen, Belgium
GZA Sint Augustinus ( Site 0356)
Wilrijk, Antwerpen, Belgium
C.I.U. Hopital Ambroise Pare ( Site 0353)
Mons, Hainaut, Belgium
OLV Ziekenhuis ( Site 0352)
Aalst, Oost-Vlaanderen, Belgium
AZ St Lucas ( Site 0349)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0354)
Leuven, Vlaams-Brabant, Belgium
Hospital das Clinicas da UFMG ( Site 0172)
Belo Horizonte, Minas Gerais, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0170)
Natal, Rio Grande do Norte, Brazil
Hospital de Clínicas de Ribeirão Preto ( Site 0171)
Ribeirão Preto, São Paulo, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166)
São Paulo, São Paulo, Brazil
Instituto Nacional Do Cancer II ( Site 0173)
Rio de Janeiro, , Brazil
Princess Margaret Cancer Centre ( Site 0102)
Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101)
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0105)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, Canada
Sociedad Oncovida S.A. ( Site 0196)
Santiago, Region M. de Santiago, Chile
Iram Cancer Research ( Site 0198)
Santiago, Region M. de Santiago, Chile
Centro Investigación del Cáncer James Lind ( Site 0194)
Temuco, Región de la Araucanía, Chile
Oncocentro ( Site 0195)
Viña del Mar, Región de Valparaíso, Chile
Anhui Provincial Hospital ( Site 1029)
Hefei, Anhui, China
Anhui Provincial Cancer Hospital ( Site 1007)
Hefei, Anhui, China
Peking Union Medical College Hospital ( Site 1001)
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital ( Site 1030)
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Xiamen University ( Site 1025)
Xiamen, Fujian, China
The First Affiliated Hospital.Sun Yat-sen University ( Site 1005)
Guangzhou, Guangdong, China
Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036)
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital ( Site 1013)
Harbin, Heilongjiang, China
Hunan Cancer Hospital ( Site 1015)
Changsha, Hunan, China
Xiangya Hospital Central-South University ( Site 1009)
Changsha, Hunan, China
Shanghai Cancer Hospital ( Site 1000)
Shanghai, Shanghai Municipality, China
Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039)
Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital ( Site 1018)
Chengdu, Sichuan, China
The First Affiliated Hospital of Xinjiang Medical University ( Site 1012)
Ürümqi, Xinjiang, China
Zhejiang Provincial People's Hospital ( Site 1021)
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital ( Site 1004)
Hangzhou, Zhejiang, China
Fundacion Centro de Investigacion Clinica CIC ( Site 0231)
Medellín, Antioquia, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 0228)
Bogotá, Bogota D.C., Colombia
Fundacion Valle del Lili ( Site 0230)
Cali, Valle del Cauca Department, Colombia
Centro Medico Imbanaco de Cali S.A ( Site 0227)
Cali, Valle del Cauca Department, Colombia
Fakultni Nemocnice Brno Bohunice ( Site 0912)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava ( Site 0909)
Ostrava, Moravskoslezský kraj, Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 0913)
Prague, , Czechia
CHU Jean Minjoz ( Site 0411)
Besançon, Doubs, France
Institut Claudius Regaud ( Site 0417)
Toulouse, Haute-Garonne, France
Centre Hospitalier Lyon Sud ( Site 0413)
Pierre-Bénite, Rhone, France
Universitaetsklinikum Freiburg ( Site 0454)
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443)
Mannheim, Baden-Wurttemberg, Germany
Klinikum der Universitaet in Muenchen ( Site 0446)
Munich, Bavaria, Germany
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453)
Munich, Bavaria, Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452)
Dresden, Saxony, Germany
Universitaetsklinik Leipzig ( Site 0456)
Leipzig, Saxony, Germany
Charite Universitaetsmedizin Berlin ( Site 0442)
Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 0445)
Hamburg, , Germany
General Hospital of Patras. St Andrews ( Site 0473)
Pátrai, Achaia, Greece
Alexandra General Hospital ( Site 0477)
Athens, Attica, Greece
Hospital Hygeia ( Site 0478)
Athens, Attica, Greece
Euromedica General Clinic of Thessaloniki ( Site 0474)
Thessaloniki, , Greece
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321)
Guatemala City, , Guatemala
Oncologika S.A. ( Site 0323)
Guatemala City, , Guatemala
Oncomedica ( Site 0320)
Guatemala City, , Guatemala
Grupo Angeles SA ( Site 0319)
Guatemala City, , Guatemala
Medi-K Cayala ( Site 0318)
Guatemala City, , Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0322)
Quetzaltenango, , Guatemala
Orszagos Onkologiai Intezet ( Site 0846)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0845)
Debrecen, , Hungary
Cork University Hospital ( Site 0504)
Cork, , Ireland
St James Hospital ( Site 0505)
Dublin, , Ireland
Rambam Medical Center ( Site 0815)
Haifa, , Israel
Hadassah Medical Center. Ein Kerem ( Site 0816)
Jerusalem, , Israel
Chaim Sheba Medical Center ( Site 0814)
Ramat Gan, , Israel
Sourasky Medical Center ( Site 0819)
Tel Aviv, , Israel
Istituto Europeo di Oncologia ( Site 0536)
Milan, Milano, Italy
Istituto di Candiolo - IRCCS ( Site 0546)
Candiolo, Piedmont, Italy
Istituto Nazionale Tumori Regina Elena ( Site 0540)
Rome, Roma, Italy
A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541)
Bologna, , Italy
Ospedale Vito Fazzi ( Site 0547)
Lecce, , Italy
IRCCS Ospedale San Raffaele ( Site 0539)
Milan, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542)
Milan, , Italy
Fondazione Giovanni Pascale Di Napoli ( Site 0544)
Napoli, , Italy
Policlinico Universitario Gemelli ( Site 0538)
Roma, , Italy
A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535)
Torino, , Italy
Aichi Cancer Center Hospital ( Site 1155)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 1159)
Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 1162)
Matsuyama, Ehime, Japan
Ehime University Hospital ( Site 1157)
Tōon, Ehime, Japan
Kurume University Hospital ( Site 1164)
Kurume, Fukuoka, Japan
Hokkaido University Hospital ( Site 1163)
Sapporo, Hokkaido, Japan
Iwate Medical University Hospital ( Site 1165)
Shiwa-gun, Iwate, Japan
University of the Ryukyus Hospital ( Site 1156)
Nakagami-gun, Okinawa, Japan
Saitama Medical University International Medical Center ( Site 1168)
Hidaka, Saitama, Japan
Saitama Cancer Center ( Site 1169)
Kitaadachi-gun, Saitama, Japan
Kyorin University Hospital ( Site 1158)
Mitaka, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center ( Site 1167)
Fukuoka, , Japan
Kagoshima City Hospital ( Site 1166)
Kagoshima, , Japan
Osaka International Cancer Institute ( Site 1161)
Osaka, , Japan
National Cancer Center Hospital ( Site 1172)
Tokyo, , Japan
Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171)
Tokyo, , Japan
Keio University Hospital ( Site 1170)
Tokyo, , Japan
Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601)
Bergen, Hordaland, Norway
Oslo Universitetssykehus Radiumhospitalet ( Site 0600)
Oslo, , Norway
Centro Medico Monte Carmelo ( Site 0289)
Arequipa, Ariqipa, Peru
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287)
Trujillo, La Libertad, Peru
Clinica San Gabriel ( Site 0296)
San Miguel, Lima region, Peru
Hospital Nacional Daniel Alcides Carrion ( Site 0293)
Callao, Lima, Peru
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290)
Lima, , Peru
Hospital Nacional Arzobispo Loayza ( Site 0292)
Lima, , Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291)
Lima, , Peru
Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741)
Chelyabinsk, Chelyabinsk Oblast, Russia
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729)
Krasnoyarsk, Krasnoyarsk Krai, Russia
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722)
Moscow, Moscow, Russia
GBUZ SPb CRPCstmc(o) ( Site 0746)
Saint Petersburg, Sankt-Peterburg, Russia
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725)
Saint Petersburg, Sankt-Peterburg, Russia
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734)
Yaroslavl, Yaroslavl Oblast, Russia
National Cancer Center ( Site 1065)
Goyang-si, Kyonggi-do, South Korea
Asan Medical Center ( Site 1062)
Seoul, Seoul, South Korea
Keimyung University Dongsan Medical Center ( Site 1066)
Daegu, Taegu-Kwangyokshi, South Korea
Severance Hospital ( Site 1063)
Seoul, , South Korea
Samsung Medical Center ( Site 1064)
Seoul, , South Korea
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637)
Badalona, Barcelona, Spain
Hosp Clin Univ de Santiago ( Site 0629)
Santiago de Compostela, La Coruna, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638)
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitari Vall d Hebron ( Site 0634)
Barcelona, , Spain
Complejo Hospitalario de Jaen ( Site 0632)
Jaén, , Spain
Hospital Clinico Universitario Lozano Blesa ( Site 0630)
Zaragoza, , Spain
Karolinska Universitetssjukhuset ( Site 0784)
Stockholm, Stockholm County, Sweden
National Taiwan University Hospital ( Site 1095)
Taipei, , Taiwan
Mackay Memorial Hospital ( Site 1094)
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital ( Site 1097)
Taoyuan District, , Taiwan
Ramathibodi Hospital, Mahidol University ( Site 1131)
Rajthevee, Bangkok, Thailand
Srinagarind Hospital. Khon Kaen University ( Site 1132)
Mueang, Changwat Khon Kaen, Thailand
Songklanagarind Hospital ( Site 1130)
Hat Yai, Changwat Songkhla, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 1133)
Chiang Mai, , Thailand
I.U. Cerrahpasa Medical Faculty ( Site 0755)
Istanbul, Istanbul, Turkey (Türkiye)
Acibadem Adana Hastanesi ( Site 0756)
Adana, , Turkey (Türkiye)
Baskent Universitesi Ankara Hastanesi ( Site 0754)
Ankara, , Turkey (Türkiye)
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876)
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882)
Lviv, Lviv Oblast, Ukraine
Royal Devon and Exeter Foundation Trust Hospital ( Site 0699)
Exeter, England, United Kingdom
ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701)
London, London, City of, United Kingdom
Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696)
London, Surrey, United Kingdom
Countries
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References
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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.
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. Erratum In: Lancet. 2024 Nov 2;404(10464):1730. doi: 10.1016/S0140-6736(24)02371-7.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-A18
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-A18
Identifier Type: OTHER
Identifier Source: secondary_id
ENGOT-cx11
Identifier Type: OTHER
Identifier Source: secondary_id
205189
Identifier Type: REGISTRY
Identifier Source: secondary_id
GOG-3047
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501972-25-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1282-6395
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-003152-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3475-A18
Identifier Type: -
Identifier Source: org_study_id
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