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)

March 1, 2024 updated by: Merck Sharp & Dohme LLC

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Uterine Cervical Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

980

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Westmead Hospital ( Site 0973)
- Queensland
  - Herston, Queensland, Australia, 4029
    - Royal Brisbane and Women s Hospital ( Site 0972)
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Monash Health-Monash Medical Centre ( Site 0970)
  - Melbourne, Victoria, Australia, 3000
    - Peter MacCallum Cancer Centre ( Site 0971)
- Western Australia
  - Subiaco, Western Australia, Australia, 6008
    - St John of God Subiaco Hospital ( Site 0969)
Austria
- Steiermark
  - Graz, Steiermark, Austria, 8036
    - Medizinische Universitat Graz ( Site 0569)
- Tirol
  - Innsbruck, Tirol, Austria, 6020
    - Medizinische Universitat Innsbruck ( Site 0566)
- Wien
  - Vienna, Wien, Austria, 1090
    - Medizinische Universität Wien ( Site 0567)
Belgium
- Antwerpen
  - Edegem, Antwerpen, Belgium, 2650
    - UZA University Hospital Antwerp ( Site 0351)
  - Wilrijk, Antwerpen, Belgium, 2610
    - GZA Sint Augustinus ( Site 0356)
- Hainaut
  - Mons, Hainaut, Belgium, 7000
    - C.I.U. Hopital Ambroise Pare ( Site 0353)
- Oost-Vlaanderen
  - Aalst, Oost-Vlaanderen, Belgium, 9300
    - OLV Ziekenhuis ( Site 0352)
  - Gent, Oost-Vlaanderen, Belgium, 9000
    - AZ St Lucas ( Site 0349)
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - UZ Leuven ( Site 0354)
Brazil
- - Rio de Janeiro, Brazil, 20220-410
    - Instituto Nacional Do Cancer II ( Site 0173)
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30130-100
    - Hospital das Clinicas da UFMG ( Site 0172)
- Rio Grande Do Norte
  - Natal, Rio Grande Do Norte, Brazil, 59075-740
    - Liga Norte Riograndense Contra o Cancer ( Site 0170)
- Sao Paulo
  - Ribeirão Preto, Sao Paulo, Brazil, 14048900
    - Hospital de Clínicas de Ribeirão Preto ( Site 0171)
  - São Paulo, Sao Paulo, Brazil, 04014-002
    - Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166)
Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Cancer Centre ( Site 0102)
- Quebec
  - Montreal, Quebec, Canada, H2X 0A9
    - Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101)
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre ( Site 0105)
  - Quebec City, Quebec, Canada, G1J 1Z4
    - Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Chile
- Araucania
  - Temuco, Araucania, Chile, 4800827
    - Centro Investigación del Cáncer James Lind ( Site 0194)
- Region M. De Santiago
  - Santiago, Region M. De Santiago, Chile, 7510032
    - Sociedad Oncovida S.A. ( Site 0196)
  - Santiago, Region M. De Santiago, Chile, 7630370
    - Iram Cancer Research ( Site 0198)
- Valparaiso
  - Vina del Mar, Valparaiso, Chile
    - Oncocentro ( Site 0195)
China
- Anhui
  - Hefei, Anhui, China, 230001
    - Anhui Provincial Hospital ( Site 1029)
  - Hefei, Anhui, China, 230031
    - Anhui Provincial Cancer Hospital ( Site 1007)
- Beijing
  - Beijing, Beijing, China, 100730
    - Peking Union Medical College Hospital ( Site 1001)
- Chongqing
  - Chongqing, Chongqing, China, 400030
    - Chongqing Cancer Hospital ( Site 1030)
- Fujian
  - Xiamen, Fujian, China, 361003
    - The First Affiliated Hospital of Xiamen University ( Site 1025)
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - The First Affiliated Hospital.Sun Yat-sen University ( Site 1005)
- Guangxi
  - Nanning, Guangxi, China, 530021
    - Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036)
- Heilongjiang
  - Harbin, Heilongjiang, China, 150081
    - Harbin Medical University Cancer Hospital ( Site 1013)
- Hunan
  - Changsha, Hunan, China, 233004
    - Hunan Cancer Hospital ( Site 1015)
  - Changsha, Hunan, China, 410008
    - Xiangya Hospital Central-South University ( Site 1009)
- Shanghai
  - Shanghai, Shanghai, China, 200032
    - Shanghai Cancer Hospital ( Site 1000)
  - Shanghai, Shanghai, China, 201204
    - Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039)
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Sichuan Cancer Hospital ( Site 1018)
- Xinjiang
  - Urumqi, Xinjiang, China, 830054
    - The First Affiliated Hospital of Xinjiang Medical University ( Site 1012)
- Zhejiang
  - Hangzhou, Zhejiang, China, 310014
    - Zhejiang Provincial People's Hospital ( Site 1021)
  - Hangzhou, Zhejiang, China, 310022
    - Zhejiang Cancer Hospital ( Site 1004)
Colombia
- Antioquia
  - Medellin, Antioquia, Colombia, 050021
    - Fundacion Centro de Investigacion Clinica CIC ( Site 0231)
- Distrito Capital De Bogota
  - Bogota, Distrito Capital De Bogota, Colombia, 110321
    - Instituto Nacional de Cancerologia E.S.E ( Site 0228)
- Valle Del Cauca
  - Cali, Valle Del Cauca, Colombia, 760032
    - Fundacion Valle del Lili ( Site 0230)
  - Cali, Valle Del Cauca, Colombia, 760042
    - Centro Medico Imbanaco de Cali S.A ( Site 0227)
Czechia
- - Praha 10, Czechia, 100 34
    - Fakultni nemocnice Kralovske Vinohrady ( Site 0913)
- Brno-mesto
  - Brno, Brno-mesto, Czechia, 602 00
    - Fakultni Nemocnice Brno Bohunice ( Site 0912)
- Moravskoslezsky Kraj
  - Ostrava, Moravskoslezsky Kraj, Czechia, 708 52
    - Fakultni nemocnice Ostrava ( Site 0909)
France
- Doubs
  - Besancon, Doubs, France, 25000
    - CHU Jean Minjoz ( Site 0411)
- Haute-Garonne
  - Toulouse, Haute-Garonne, France, 31059
    - Institut Claudius Regaud ( Site 0417)
- Rhone
  - Pierre Benite, Rhone, France, 69310
    - Centre Hospitalier Lyon Sud ( Site 0413)
Germany
- - Berlin, Germany, 13353
    - Charite Universitaetsmedizin Berlin ( Site 0442)
  - Hamburg, Germany, 20246
    - Universitaetsklinikum Hamburg-Eppendorf ( Site 0445)
- Baden-Wurttemberg
  - Freiburg, Baden-Wurttemberg, Germany, 79106
    - Universitaetsklinikum Freiburg ( Site 0454)
  - Mannheim, Baden-Wurttemberg, Germany, 68167
    - Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443)
- Bayern
  - Muenchen, Bayern, Germany, 80336
    - Klinikum der Universitaet in Muenchen ( Site 0446)
  - Muenchen, Bayern, Germany, 81675
    - Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453)
- Sachsen
  - Dresden, Sachsen, Germany, 01307
    - Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452)
  - Leipzig, Sachsen, Germany, 04103
    - Universitaetsklinik Leipzig ( Site 0456)
Greece
- - Thessaloniki, Greece, 546 45
    - Euromedica General Clinic of Thessaloniki ( Site 0474)
- Achaia
  - Patras, Achaia, Greece, 262 00
    - General Hospital of Patras. St Andrews ( Site 0473)
- Attiki
  - Athens, Attiki, Greece, 11528
    - Alexandra General Hospital ( Site 0477)
  - Athens, Attiki, Greece, 151 23
    - Hospital Hygeia ( Site 0478)
Guatemala
- - Guatemala, Guatemala, 01010
    - Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321)
  - Guatemala, Guatemala, 01010
    - Oncologika S.A. ( Site 0323)
  - Guatemala, Guatemala, 01010
    - Oncomedica ( Site 0320)
  - Guatemala, Guatemala, 01015
    - Grupo Angeles SA ( Site 0319)
  - Guatemala, Guatemala, 01016
    - Medi-K Cayala ( Site 0318)
  - Quetzaltenango, Guatemala, 09002
    - Centro Medico Integral De Cancerología (CEMIC) ( Site 0322)
Hungary
- - Budapest, Hungary, 1122
    - Orszagos Onkologiai Intezet ( Site 0846)
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont ( Site 0845)
Ireland
- - Cork, Ireland, T12 DC4A
    - Cork University Hospital ( Site 0504)
  - Dublin, Ireland, D8
    - St James Hospital ( Site 0505)
Israel
- - Haifa, Israel, 3109601
    - Rambam Medical Center ( Site 0815)
  - Jerusalem, Israel, 9112001
    - Hadassah Medical Center. Ein Kerem ( Site 0816)
  - Ramat Gan, Israel, 5262000
    - Chaim Sheba Medical Center ( Site 0814)
  - Tel Aviv, Israel, 6423906
    - Sourasky Medical Center ( Site 0819)
Italy
- - Bologna, Italy, 40138
    - A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541)
  - Lecce, Italy, 73100
    - Ospedale Vito Fazzi ( Site 0547)
  - Milano, Italy, 20132
    - IRCCS Ospedale San Raffaele ( Site 0539)
  - Milano, Italy, 20133
    - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542)
  - Napoli, Italy, 80131
    - Fondazione Giovanni Pascale Di Napoli ( Site 0544)
  - Roma, Italy, 00168
    - Policlinico Universitario Gemelli ( Site 0538)
  - Torino, Italy, 10126
    - A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535)
- Milano
  - Milan, Milano, Italy, 20141
    - Istituto Europeo di Oncologia ( Site 0536)
- Piemonte
  - Candiolo, Piemonte, Italy, 10060
    - Istituto di Candiolo - IRCCS ( Site 0546)
- Roma
  - Rome, Roma, Italy, 00144
    - Istituto Nazionale Tumori Regina Elena ( Site 0540)
Japan
- - Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center ( Site 1167)
  - Kagoshima, Japan, 890-8760
    - Kagoshima City Hospital ( Site 1166)
  - Osaka, Japan, 541-8567
    - Osaka International Cancer Institute ( Site 1161)
  - Tokyo, Japan, 104-0045
    - National Cancer Center Hospital ( Site 1172)
  - Tokyo, Japan, 135-8550
    - Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171)
  - Tokyo, Japan, 160-8582
    - Keio University Hospital ( Site 1170)
- Aichi
  - Nagoya, Aichi, Japan, 464-8681
    - Aichi Cancer Center Hospital ( Site 1155)
- Chiba
  - Kashiwa, Chiba, Japan, 2778577
    - National Cancer Center Hospital East ( Site 1159)
- Ehime
  - Matsuyama, Ehime, Japan, 791-0280
    - National Hospital Organization Shikoku Cancer Center ( Site 1162)
  - Toon, Ehime, Japan, 790-0295
    - Ehime University Hospital ( Site 1157)
- Fukuoka
  - Kurume, Fukuoka, Japan, 830-0011
    - Kurume University Hospital ( Site 1164)
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Hokkaido University Hospital ( Site 1163)
- Iwate
  - Shiwa-gun, Iwate, Japan, 028-3695
    - Iwate Medical University Hospital ( Site 1165)
- Okinawa
  - Nakagami-gun, Okinawa, Japan, 903-0215
    - University of the Ryukyus Hospital ( Site 1156)
- Saitama
  - Hidaka, Saitama, Japan, 350-1298
    - Saitama Medical University International Medical Center ( Site 1168)
  - Kitaadachi-gun, Saitama, Japan, 362-0806
    - Saitama Cancer Center ( Site 1169)
- Tokyo
  - Mitaka, Tokyo, Japan, 181-8611
    - Kyorin University Hospital ( Site 1158)
Korea, Republic of
- - Seoul, Korea, Republic of, 03722
    - Severance Hospital ( Site 1063)
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center ( Site 1064)
- Kyonggi-do
  - Goyang-si, Kyonggi-do, Korea, Republic of, 10408
    - National Cancer Center ( Site 1065)
- Seoul
  - Seoul., Seoul, Korea, Republic of, 05505
    - Asan Medical Center ( Site 1062)
- Taegu-Kwangyokshi
  - Daegu, Taegu-Kwangyokshi, Korea, Republic of, 42601
    - Keimyung University Dongsan Medical Center ( Site 1066)
Norway
- - Oslo, Norway, 0379
    - Oslo Universitetssykehus Radiumhospitalet ( Site 0600)
- Hordaland
  - Bergen, Hordaland, Norway, 5021
    - Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601)
Peru
- - Lima, Peru, 15036
    - Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290)
  - Lima, Peru, 15082
    - Hospital Nacional Arzobispo Loayza ( Site 0292)
  - Lima, Peru, 15082
    - Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291)
- Ariqipa
  - Arequipa, Ariqipa, Peru, 04001
    - Centro Medico Monte Carmelo ( Site 0289)
- La Libertad
  - Trujillo, La Libertad, Peru, 13013
    - Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287)
- Lima
  - Callao, Lima, Peru, 07021
    - Hospital Nacional Daniel Alcides Carrion ( Site 0293)
  - San Miguel, Lima, Peru, 15087
    - Clinica San Gabriel ( Site 0296)
Russian Federation
- Chelyabinskaya Oblast
  - Chelyabinsk, Chelyabinskaya Oblast, Russian Federation, 454087
    - Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741)
- Krasnoyarskiy Kray
  - Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation, 660133
    - Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729)
- Moskva
  - Moscow, Moskva, Russian Federation, 125284
    - MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722)
- Sankt-Peterburg
  - Saint Petersburg, Sankt-Peterburg, Russian Federation, 197758
    - GBUZ SPb CRPCstmc(o) ( Site 0746)
  - St. Petersburg, Sankt-Peterburg, Russian Federation, 197758
    - National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725)
- Yaroslavskaya Oblast
  - Yaroslavl, Yaroslavskaya Oblast, Russian Federation, 150054
    - Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734)
Spain
- - Barcelona, Spain, 08035
    - Hospital Universitari Vall d Hebron ( Site 0634)
  - Jaen, Spain, 23007
    - Complejo Hospitalario de Jaen ( Site 0632)
  - Zaragoza, Spain, 50009
    - Hospital Clinico Universitario Lozano Blesa ( Site 0630)
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637)
- La Coruna
  - Santiago de Compostela, La Coruna, Spain, 15706
    - Hosp Clin Univ de Santiago ( Site 0629)
- Madrid
  - Pozuelo de Alarcon, Madrid, Spain, 28223
    - HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638)
Sweden
- Stockholms Lan
  - Stockholm, Stockholms Lan, Sweden, 171 76
    - Karolinska Universitetssjukhuset ( Site 0784)
Taiwan
- - Taipei, Taiwan, 100
    - National Taiwan University Hospital ( Site 1095)
  - Taipei, Taiwan, 104
    - Mackay Memorial Hospital ( Site 1094)
  - Taoyuan, Taiwan, 333
    - Linkou Chang Gung Memorial Hospital ( Site 1097)
Thailand
- - Chiang Mai, Thailand, 50200
    - Maharaj Nakorn Chiang Mai Hospital ( Site 1133)
- Khon Kaen
  - Mueang, Khon Kaen, Thailand, 40002
    - Srinagarind Hospital. Khon Kaen University ( Site 1132)
- Krung Thep Maha Nakhon
  - Rajthevee, Krung Thep Maha Nakhon, Thailand, 10400
    - Ramathibodi Hospital, Mahidol University ( Site 1131)
- Songkhla
  - Hatyai, Songkhla, Thailand, 90110
    - Songklanagarind Hospital ( Site 1130)
Turkey
- - Adana, Turkey, 01130
    - Acibadem Adana Hastanesi ( Site 0756)
  - Ankara, Turkey, 06490
    - Baskent Universitesi Ankara Hastanesi ( Site 0754)
- Istanbul
  - Istambul, Istanbul, Turkey, 34093
    - I.U. Cerrahpasa Medical Faculty ( Site 0755)
Ukraine
- Kharkivska Oblast
  - Kharkiv, Kharkivska Oblast, Ukraine, 61024
    - Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876)
- Lvivska Oblast
  - Lviv, Lvivska Oblast, Ukraine, 79031
    - Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882)
United Kingdom
- England
  - Exeter, England, United Kingdom
    - Royal Devon and Exeter Foundation Trust Hospital ( Site 0699)
- London, City Of
  - London, London, City Of, United Kingdom, SW3 6JJ
    - ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701)
- Surrey
  - London, Surrey, United Kingdom, SM3 5PT
    - Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696)
United States
- Arizona
  - Phoenix, Arizona, United States, 85016
    - HonorHealth Research Institute - Biltmore ( Site 8009)
- California
  - Los Angeles, California, United States, 90095
    - UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027)
  - Newport Beach, California, United States, 92663
    - Hoag Memorial Hospital Presbyterian ( Site 0038)
  - Sacramento, California, United States, 95817
    - UC Davis Comprehensive Cancer Center ( Site 0017)
- Colorado
  - Denver, Colorado, United States, 80262
    - University of Colorado Health Sciences Center and Hospital ( Site 0028)
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Smilow Cancer Center at Yale-New Haven ( Site 0023)
- Florida
  - Orlando, Florida, United States, 32804
    - AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009)
- Indiana
  - Fort Wayne, Indiana, United States, 46845
    - Parkview Research Center at Parkview Regional Medical Center ( Site 0026)
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky Markey Cancer Center ( Site 0015)
- Louisiana
  - Baton Rouge, Louisiana, United States, 70817
    - Our Lady of the Lake Regional Medical Center. ( Site 0031)
  - Covington, Louisiana, United States, 70433
    - Women's Cancer Care ( Site 0039)
- Michigan
  - Detroit, Michigan, United States, 48201
    - Karmanos Cancer Institute ( Site 0018)
- Minnesota
  - Minneapolis, Minnesota, United States, 55404
    - Minnesota Oncology Hematology, PA ( Site 8007)
- New Mexico
  - Albuquerque, New Mexico, United States, 87106
    - University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019)
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - University of North Carolina at Chapel Hill ( Site 0025)
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center ( Site 0046)
- Ohio
  - Columbus, Ohio, United States, 43210
    - The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
- Oregon
  - Eugene, Oregon, United States, 97401
    - Willamette Valley Cancer Institute and Research Center ( Site 8000)
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Medical Center ( Site 0013)
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15244
    - Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030)
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Hollings Cancer Center ( Site 0007)
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Gynecology Oncology ( Site 0003)
- Texas
  - Austin, Texas, United States, 78731
    - Texas Oncology-Austin Central ( Site 8006)
  - Fort Worth, Texas, United States, 76104
    - Texas Oncology-Fort Worth Cancer Center ( Site 8001)
  - San Antonio, Texas, United States, 78240
    - Texas Oncology-San Antonio Medical Center ( Site 8002)
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology-The Woodlands ( Site 8003)
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - UVA Health System ( Site 0005)
  - Richmond, Virginia, United States, 23219
    - Virginia Commonwealth University ( Site 0024)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Biological: Pembrolizumab IV infusion Other Names: MK-3475 KEYTRUDA® Drug: Cisplatin IV infusion Other Names: Platinol® Platinol®-AQ Radiation: External Beam Radiotherapy (EBRT) Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed Radiation: Brachytherapy Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed
Experimental: 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).	Drug: Cisplatin IV infusion Other Names: Platinol® Platinol®-AQ Drug: Placebo for pembrolizumab IV infusion Radiation: External Beam Radiotherapy (EBRT) Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed Radiation: Brachytherapy Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Biological: Pembrolizumab

IV infusion

Other Names:

MK-3475
KEYTRUDA®

Drug: Cisplatin

IV infusion

Other Names:

Platinol®
Platinol®-AQ

Radiation: External Beam Radiotherapy (EBRT)

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Radiation: Brachytherapy

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Experimental: 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).

Drug: Cisplatin

IV infusion

Other Names:

Platinol®
Platinol®-AQ

Drug: Placebo for pembrolizumab

IV infusion

Radiation: External Beam Radiotherapy (EBRT)

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Radiation: Brachytherapy

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator Time Frame: Up to approximately 38 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.	Up to approximately 38 months
Overall Survival (OS) Time Frame: Up to approximately 46 months	OS is the time from randomization to death due to any cause.	Up to approximately 46 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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) Time Frame: Up to approximately 38 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.	Up to approximately 38 months
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 Time Frame: Up to approximately 38 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 38 months.	Up to approximately 38 months
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) Time Frame: Up to approximately 38 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 24 using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 38 months.	Up to approximately 38 months
Overall Survival (OS) at Month 36 Time Frame: Up to approximately 46 months	OS is the time from randomization to death due to any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 36 using the entire OS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 46 months.	Up to approximately 46 months
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 Time Frame: Up to approximately 38 months	For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. CR data will be cumulated to a certain cut-off date and the analysis will be performed to estimate the CR rate at Week 12 using the entire CR data up to the cut-off date. The cut-off date is estimated to be approximately 38 months.	Up to approximately 38 months
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) Time Frame: Up to approximately 38 months	For participants who demonstrated a confirmed Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) per RECIST 1.1, CR rate is defined as the percentage of participants who experienced a CR. CR data will be cumulated to a certain cut-off date and the analysis will be performed to estimate the CR rate at Week 12 using the entire CR data up to the cut-off date. The cut-off date is estimated to be approximately 38 months.	Up to approximately 38 months
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator Time Frame: Up to approximately 46 months	ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.	Up to approximately 46 months
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) Time Frame: Up to approximately 46 months	ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.	Up to approximately 46 months
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 Time Frame: Up to approximately 38 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.	Up to approximately 38 months
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) Time Frame: Up to approximately 38 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.	Up to approximately 38 months
Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by the Investigator Time Frame: Up to approximately 46 months	OS is the time from randomization to death due to any cause.	Up to approximately 46 months
Overall Survival (OS) in Programmed Cell Death 1 Ligand 1 (PD-L1) Positive Participants as Assessed by Blinded Independent Central Review (BICR) Time Frame: Up to approximately 46 months	OS is the time from randomization to death due to any cause.	Up to approximately 46 months
Progression-Free Survival (PFS) After Next-Line Treatment (PFS 2) Following Discontinuation of Study Treatment Time Frame: Up to approximately 46 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) on next-line treatment or death due to any cause, whichever occurs first, as assessed by the investigator.	Up to approximately 46 months
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 Time Frame: Baseline and up to approximately 46 months	The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea/vomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.	Baseline and up to approximately 46 months
Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score Time Frame: Baseline and up to approximately 46 months	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). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. 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 46 months
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 Time Frame: Baseline and up to approximately 46 months	The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and/or treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual/ vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. The change from baseline in EORTC QLQ-CX24 score will be presented.	Baseline and up to approximately 46 months
Number of Participants Who Experience One or More Adverse Events (AEs) Time Frame: Up to approximately 46 months	An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.	Up to approximately 46 months
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) Time Frame: Up to approximately 46 months	An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.	Up to approximately 46 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

GOG Foundation

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Investigators

Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Merck Clinical Trials Information

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2020

Primary Completion (Estimated)

January 17, 2025

Study Completion (Estimated)

January 17, 2025

Study Registration Dates

First Submitted

December 23, 2019

First Submitted That Met QC Criteria

January 7, 2020

First Posted (Actual)

January 9, 2020

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

3475-A18
MK-3475-A18 (Other Identifier: Merck)
KEYNOTE-A18 (Other Identifier: Merck)
ENGOT-cx11 (Other Identifier: European Network for Gynaecological Oncological Trial groups)
205189 (Registry Identifier: JAPAC-CTI)
GOG-3047 (Other Identifier: Gynecologic Oncology Group Foundation)
2022-501972-25-00 (Registry Identifier: EU CT)
2019-003152-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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