Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer... | NCT04221945 | Trialant

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer... | NCT04221945 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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

HonorHealth Research Institute - Biltmore ( Site 8009)

Phoenix, Arizona 85016, United States

UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027)

Los Angeles, California 90095, United States

Hoag Memorial Hospital Presbyterian ( Site 0038)

Newport Beach, California 92663, United States

UC Davis Comprehensive Cancer Center ( Site 0017)

Sacramento, California 95817, United States

University of Colorado Health Sciences Center and Hospital ( Site 0028)

Denver, Colorado 80262, United States

Smilow Cancer Center at Yale-New Haven ( Site 0023)

New Haven, Connecticut 06510, United States

AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009)

Orlando, Florida 32804, United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0026)

Fort Wayne, Indiana 46845, United States

University of Kentucky Markey Cancer Center ( Site 0015)

Lexington, Kentucky 40536, United States

Our Lady of the Lake Regional Medical Center. ( Site 0031)

Baton Rouge, Louisiana 70817, United States

Women's Cancer Care ( Site 0039)

Covington, Louisiana 70433, United States

Karmanos Cancer Institute ( Site 0018)

Detroit, Michigan 48201, United States

Minnesota Oncology Hematology, PA ( Site 8007)

Minneapolis, Minnesota 55404, United States

University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019)

Albuquerque, New Mexico 87106, United States

University of North Carolina at Chapel Hill ( Site 0025)

Chapel Hill, North Carolina 27514, United States

Sanford Bismarck Medical Center ( Site 0046)

Bismarck, North Dakota 58501, United States

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C

Columbus, Ohio 43210, United States

Willamette Valley Cancer Institute and Research Center ( Site 8000)

Eugene, Oregon 97401, United States

Legacy Good Samaritan Medical Center ( Site 0013)

Portland, Oregon 97210, United States

Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030)

Pittsburgh, Pennsylvania 15244, United States

Hollings Cancer Center ( Site 0007)

Charleston, South Carolina 29425, United States

Sanford Gynecology Oncology ( Site 0003)

Sioux Falls, South Dakota 57104, United States

Texas Oncology-Austin Central ( Site 8006)

Austin, Texas 78731, United States

Texas Oncology-Fort Worth Cancer Center ( Site 8001)

Fort Worth, Texas 76104, United States

Texas Oncology-San Antonio Medical Center ( Site 8002)

San Antonio, Texas 78240, United States

Texas Oncology-The Woodlands ( Site 8003)

The Woodlands, Texas 77380, United States

UVA Health System ( Site 0005)

Charlottesville, Virginia 22908, United States

Virginia Commonwealth University ( Site 0024)

Richmond, Virginia 23219, United States

Westmead Hospital ( Site 0973)

Westmead, New South Wales 2145, Australia

Royal Brisbane and Women s Hospital ( Site 0972)

Herston, Queensland 4029, Australia

Monash Health-Monash Medical Centre ( Site 0970)

Clayton, Victoria 3168, Australia

Peter MacCallum Cancer Centre ( Site 0971)

Melbourne, Victoria 3000, Australia

St John of God Subiaco Hospital ( Site 0969)

Subiaco, Western Australia 6008, Australia

Medizinische Universität Wien ( Site 0567)

Vienna, State of Vienna 1090, Austria

Medizinische Universitat Graz ( Site 0569)

Graz, Styria 8036, Austria

Medizinische Universitat Innsbruck ( Site 0566)

Innsbruck, Tyrol 6020, Austria

UZA University Hospital Antwerp ( Site 0351)

Edegem, Antwerpen 2650, Belgium

GZA Sint Augustinus ( Site 0356)

Wilrijk, Antwerpen 2610, Belgium

C.I.U. Hopital Ambroise Pare ( Site 0353)

Mons, Hainaut 7000, Belgium

OLV Ziekenhuis ( Site 0352)

Aalst, Oost-Vlaanderen 9300, Belgium

AZ St Lucas ( Site 0349)

Ghent, Oost-Vlaanderen 9000, Belgium

UZ Leuven ( Site 0354)

Leuven, Vlaams-Brabant 3000, Belgium

Hospital das Clinicas da UFMG ( Site 0172)

Belo Horizonte, Minas Gerais 30130-100, Brazil

Liga Norte Riograndense Contra o Cancer ( Site 0170)

Natal, Rio Grande do Norte 59075-740, Brazil

Hospital de Clínicas de Ribeirão Preto ( Site 0171)

Ribeirão Preto, São Paulo 14048900, Brazil

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166)

São Paulo, São Paulo 04014-002, Brazil

Instituto Nacional Do Cancer II ( Site 0173)

Rio de Janeiro, 20220-410, Brazil

Princess Margaret Cancer Centre ( Site 0102)

Toronto, Ontario M5G 2M9, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101)

Montreal, Quebec H2X 0A9, Canada

McGill University Health Centre ( Site 0105)

Montreal, Quebec H4A 3J1, Canada

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec G1J 1Z4, Canada

Centro Investigación del Cáncer James Lind ( Site 0194)

Temuco, Araucania 4800827, Chile

Sociedad Oncovida S.A. ( Site 0196)

Santiago, Region M. de Santiago 7510032, Chile

Iram Cancer Research ( Site 0198)

Santiago, Region M. de Santiago 7630370, Chile

Oncocentro ( Site 0195)

Viña del Mar, Valparaiso, Chile

Anhui Provincial Hospital ( Site 1029)

Hefei, Anhui 230001, China

Anhui Provincial Cancer Hospital ( Site 1007)

Hefei, Anhui 230031, China

Peking Union Medical College Hospital ( Site 1001)

Beijing, Beijing Municipality 100730, China

Chongqing Cancer Hospital ( Site 1030)

Chongqing, Chongqing Municipality 400030, China

The First Affiliated Hospital of Xiamen University ( Site 1025)

Xiamen, Fujian 361003, China

The First Affiliated Hospital.Sun Yat-sen University ( Site 1005)

Guangzhou, Guangdong 510080, China

Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036)

Nanning, Guangxi 530021, China

Harbin Medical University Cancer Hospital ( Site 1013)

Harbin, Heilongjiang 150081, China

Hunan Cancer Hospital ( Site 1015)

Changsha, Hunan 233004, China

Xiangya Hospital Central-South University ( Site 1009)

Changsha, Hunan 410008, China

Shanghai Cancer Hospital ( Site 1000)

Shanghai, Shanghai Municipality 200032, China

Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039)

Shanghai, Shanghai Municipality 201204, China

Sichuan Cancer Hospital ( Site 1018)

Chengdu, Sichuan 610041, China

The First Affiliated Hospital of Xinjiang Medical University ( Site 1012)

Ürümqi, Xinjiang 830054, China

Zhejiang Provincial People's Hospital ( Site 1021)

Hangzhou, Zhejiang 310014, China

Zhejiang Cancer Hospital ( Site 1004)

Hangzhou, Zhejiang 310022, China

Fundacion Centro de Investigacion Clinica CIC ( Site 0231)

Medellín, Antioquia 050021, Colombia

Instituto Nacional de Cancerologia E.S.E ( Site 0228)

Bogotá, Bogota D.C. 110321, Colombia

Fundacion Valle del Lili ( Site 0230)

Cali, Valle del Cauca Department 760032, Colombia

Centro Medico Imbanaco de Cali S.A ( Site 0227)

Cali, Valle del Cauca Department 760042, Colombia

Fakultni Nemocnice Brno Bohunice ( Site 0912)

Brno, Brno-mesto 602 00, Czechia

Fakultni nemocnice Ostrava ( Site 0909)

Ostrava, Moravian-Silesian Region 708 52, Czechia

Fakultni nemocnice Kralovske Vinohrady ( Site 0913)

Prague, 100 34, Czechia

CHU Jean Minjoz ( Site 0411)

Besançon, Doubs 25000, France

Institut Claudius Regaud ( Site 0417)

Toulouse, Haute-Garonne 31059, France

Centre Hospitalier Lyon Sud ( Site 0413)

Pierre-Bénite, Rhone 69310, France

Universitaetsklinikum Freiburg ( Site 0454)

Freiburg im Breisgau, Baden-Wurttemberg 79106, Germany

Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443)

Mannheim, Baden-Wurttemberg 68167, Germany

Klinikum der Universitaet in Muenchen ( Site 0446)

Munich, Bavaria 80336, Germany

Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453)

Munich, Bavaria 81675, Germany

Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452)

Dresden, Saxony 01307, Germany

Universitaetsklinik Leipzig ( Site 0456)

Leipzig, Saxony 04103, Germany

Charite Universitaetsmedizin Berlin ( Site 0442)

Berlin, 13353, Germany

Universitaetsklinikum Hamburg-Eppendorf ( Site 0445)

Hamburg, 20246, Germany

General Hospital of Patras. St Andrews ( Site 0473)

Pátrai, Achaia 262 00, Greece

Alexandra General Hospital ( Site 0477)

Athens, Attica 11528, Greece

Hospital Hygeia ( Site 0478)

Athens, Attica 151 23, Greece

Euromedica General Clinic of Thessaloniki ( Site 0474)

Thessaloniki, 546 45, Greece

Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321)

Guatemala City, 01010, Guatemala

Oncologika S.A. ( Site 0323)

Guatemala City, 01010, Guatemala

Oncomedica ( Site 0320)

Guatemala City, 01010, Guatemala

Grupo Angeles SA ( Site 0319)

Guatemala City, 01015, Guatemala

Medi-K Cayala ( Site 0318)

Guatemala City, 01016, Guatemala

Centro Medico Integral De Cancerología (CEMIC) ( Site 0322)

Quetzaltenango, 09002, Guatemala

Orszagos Onkologiai Intezet ( Site 0846)

Budapest, 1122, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 0845)

Debrecen, 4032, Hungary

Cork University Hospital ( Site 0504)

Cork, T12 DC4A, Ireland

St James Hospital ( Site 0505)

Dublin, D8, Ireland

Rambam Medical Center ( Site 0815)

Haifa, 3109601, Israel

Hadassah Medical Center. Ein Kerem ( Site 0816)

Jerusalem, 9112001, Israel

Chaim Sheba Medical Center ( Site 0814)

Ramat Gan, 5262000, Israel

Sourasky Medical Center ( Site 0819)

Tel Aviv, 6423906, Israel

Istituto Europeo di Oncologia ( Site 0536)

Milan, Milano 20141, Italy

Istituto di Candiolo - IRCCS ( Site 0546)

Candiolo, Piedmont 10060, Italy

Istituto Nazionale Tumori Regina Elena ( Site 0540)

Rome, Roma 00144, Italy

A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541)

Bologna, 40138, Italy

Ospedale Vito Fazzi ( Site 0547)

Lecce, 73100, Italy

IRCCS Ospedale San Raffaele ( Site 0539)

Milan, 20132, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542)

Milan, 20133, Italy

Fondazione Giovanni Pascale Di Napoli ( Site 0544)

Naples, 80131, Italy

Policlinico Universitario Gemelli ( Site 0538)

Roma, 00168, Italy

A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535)

Torino, 10126, Italy

Aichi Cancer Center Hospital ( Site 1155)

Nagoya, Aichi-ken 464-8681, Japan

National Cancer Center Hospital East ( Site 1159)

Kashiwa, Chiba 2778577, Japan

National Hospital Organization Shikoku Cancer Center ( Site 1162)

Matsuyama, Ehime 791-0280, Japan

Ehime University Hospital ( Site 1157)

Tōon, Ehime 790-0295, Japan

Kurume University Hospital ( Site 1164)

Kurume, Fukuoka 830-0011, Japan

Hokkaido University Hospital ( Site 1163)

Sapporo, Hokkaido 060-8648, Japan

Iwate Medical University Hospital ( Site 1165)

Shiwa-gun, Iwate 028-3695, Japan

University of the Ryukyus Hospital ( Site 1156)

Nakagami-gun, Okinawa 903-0215, Japan

Saitama Medical University International Medical Center ( Site 1168)

Hidaka, Saitama 350-1298, Japan

Saitama Cancer Center ( Site 1169)

Kitaadachi-gun, Saitama 362-0806, Japan

Kyorin University Hospital ( Site 1158)

Mitaka, Tokyo 181-8611, Japan

National Hospital Organization Kyushu Cancer Center ( Site 1167)

Fukuoka, 811-1395, Japan

Kagoshima City Hospital ( Site 1166)

Kagoshima, 890-8760, Japan

Osaka International Cancer Institute ( Site 1161)

Osaka, 541-8567, Japan

National Cancer Center Hospital ( Site 1172)

Tokyo, 104-0045, Japan

Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171)

Tokyo, 135-8550, Japan

Keio University Hospital ( Site 1170)

Tokyo, 160-8582, Japan

Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601)

Bergen, Hordaland 5021, Norway

Oslo Universitetssykehus Radiumhospitalet ( Site 0600)

Oslo, 0379, Norway

Centro Medico Monte Carmelo ( Site 0289)

Arequipa, Ariqipa 04001, Peru

Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287)

Trujillo, La Libertad 13013, Peru

Clinica San Gabriel ( Site 0296)

San Miguel, Lima region 15087, Peru

Hospital Nacional Daniel Alcides Carrion ( Site 0293)

Callao, Lima 07021, Peru

Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290)

Lima, 15036, Peru

Hospital Nacional Arzobispo Loayza ( Site 0292)

Lima, 15082, Peru

Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291)

Lima, 15082, Peru

Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741)

Chelyabinsk, Chelyabinsk Oblast 454087, Russia

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729)

Krasnoyarsk, Krasnoyarsk Krai 660133, Russia

MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722)

Moscow, Moscow 125284, Russia

GBUZ SPb CRPCstmc(o) ( Site 0746)

Saint Petersburg, Sankt-Peterburg 197758, Russia

National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725)

Saint Petersburg, Sankt-Peterburg 197758, Russia

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734)

Yaroslavl, Yaroslavl Oblast 150054, Russia

National Cancer Center ( Site 1065)

Goyang-si, Kyonggi-do 10408, South Korea

Asan Medical Center ( Site 1062)

Seoul, Seoul 05505, South Korea

Keimyung University Dongsan Medical Center ( Site 1066)

Daegu, Taegu-Kwangyokshi 42601, South Korea

Severance Hospital ( Site 1063)

Seoul, 03722, South Korea

Samsung Medical Center ( Site 1064)

Seoul, 06351, South Korea

Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637)

Badalona, Barcelona 08916, Spain

Hosp Clin Univ de Santiago ( Site 0629)

Santiago de Compostela, La Coruna 15706, Spain

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638)

Pozuelo de Alarcón, Madrid 28223, Spain

Hospital Universitari Vall d Hebron ( Site 0634)

Barcelona, 08035, Spain

Complejo Hospitalario de Jaen ( Site 0632)

Jaén, 23007, Spain

Hospital Clinico Universitario Lozano Blesa ( Site 0630)

Zaragoza, 50009, Spain

Karolinska Universitetssjukhuset ( Site 0784)

Stockholm, Stockholm County 171 76, Sweden

National Taiwan University Hospital ( Site 1095)

Taipei, 100, Taiwan

Mackay Memorial Hospital ( Site 1094)

Taipei, 104, Taiwan

Linkou Chang Gung Memorial Hospital ( Site 1097)

Taoyuan, 333, Taiwan

Ramathibodi Hospital, Mahidol University ( Site 1131)

Rajthevee, Bangkok 10400, Thailand

Srinagarind Hospital. Khon Kaen University ( Site 1132)

Mueang, Changwat Khon Kaen 40002, Thailand

Songklanagarind Hospital ( Site 1130)

Hat Yai, Changwat Songkhla 90110, Thailand

Maharaj Nakorn Chiang Mai Hospital ( Site 1133)

Chiang Mai, 50200, Thailand

I.U. Cerrahpasa Medical Faculty ( Site 0755)

Istanbul, Istanbul 34093, Turkey (Türkiye)

Acibadem Adana Hastanesi ( Site 0756)

Adana, 01130, Turkey (Türkiye)

Baskent Universitesi Ankara Hastanesi ( Site 0754)

Ankara, 06490, Turkey (Türkiye)

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876)

Kharkiv, Kharkiv Oblast 61024, Ukraine

Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882)

Lviv, Lviv Oblast 79031, Ukraine

Royal Devon and Exeter Foundation Trust Hospital ( Site 0699)

Exeter, England, United Kingdom

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701)

London, London, City of SW3 6JJ, United Kingdom

Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696)

London, Surrey SM3 5PT, United Kingdom