Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy... | NCT04210115 | Trialant

Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy... | NCT04210115 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of CTX N+ M0 or cT2-T4a NX M0 ESCC, GEJC, EAC, or histologically or cytologically confirmed diagnosis of cTX N+ M1 cervical or upper thoracic esophageal carcinoma with supraclavicular lymph node metastases only

Is deemed suitable for dCRT

Is ineligible for curative surgery based on the documented opinion of a qualified medical/surgical/radiation oncologist.

Is not expected to require tumor resection during the course of the study

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of the first dose of study treatment

Has adequate organ function

Male participants must use adequate contraception (a male condom plus partner use of an additional contraceptive method) unless confirmed to be azoospermic (vasectomized or secondary to medical cause) and refrain from donating sperm during the study treatment period and through 90 days after the last dose of chemotherapy

Female participants who are a Woman of Childbearing Potential (WOCBP) must use contraception that is highly effective (with a failure rate of <1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, during the study treatment period through 180 days after the last dose of chemotherapy or 120 days after the last dose of pembrolizumab, whichever is greater, and agree not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period

Female participants must not be pregnant or breastfeeding

Exclusion Criteria:

Has direct invasion of tumor into adjacent organs such as the aorta or trachea or has radiographic evidence of >90 degree encasement or invasion of a major blood vessel, or of intratumoral cavitation

Has had major surgery other than for insertion of a feeding tube, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipates the need for major surgery during study treatment; participants with gastric or esophageal fistulae are excluded

Has had weight loss of >20% in the previous 3 months

Has had prior chemotherapy or radiotherapy for esophageal cancer

Has had a myocardial infarction within the past 6 months

Has symptomatic congestive heart failure

Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)

Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed

Has received any prior systemic anticancer therapy for esophageal cancer including investigational agents

Has not recovered from all adverse events (AEs) due to previous non-anticancer therapies to ≤Grade 1 or Baseline

Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment

Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded from the study. Participants with localized prostate cancer that has undergone potentially curative treatment can be enrolled in the study.

Has severe hypersensitivity (≥Grade 3) to pembrolizumab, any of the study chemotherapy agents, or their excipients

Has an active autoimmune disease that has required systemic treatment in past 2 years

Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis

Has an active infection requiring systemic therapy

Has a known history of human immunodeficiency virus (HIV) infection

Has a known history of Hepatitis B or known active Hepatitis C virus infection

Has a known history of active tuberculosis (TB; Bacillus tuberculosis)

Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment (180 days for participants receiving cisplatin who are breastfeeding)

Has had an allogeneic tissue/solid organ transplant

MemorialCare Health System - Long Beach Medical Center-Oncology ( Site 0691)

Long Beach, California 90806, United States

Columbus Regional Research Institute ( Site 0047)

Columbus, Georgia 31904, United States

University of Kansas Cancer Center ( Site 0023)

Westwood, Kansas 66205, United States

Cancer Center of Kansas ( Site 0058)

Wichita, Kansas 67214, United States

University Medical Center ( Site 0035)

New Orleans, Louisiana 70112, United States

Greater Baltimore Medical Center ( Site 0031)

Baltimore, Maryland 21204, United States

Dana Farber Cancer Center ( Site 0034)

Boston, Massachusetts 02215, United States

Henry Ford Hospital ( Site 0685)

Detroit, Michigan 48202, United States

University of Missouri ( Site 0688)

Columbia, Missouri 65212, United States

Renown Regional Medical Center ( Site 0706)

Reno, Nevada 89502, United States

Rutgers Cancer Institute of New Jersey ( Site 0695)

New Brunswick, New Jersey 08903, United States

Weill Cornell Medical College ( Site 0053)

New York, New York 10065, United States

Stephenson Cancer Center ( Site 0044)

Oklahoma City, Oklahoma 73104, United States

Oregon Health & Science University Center for Health & Healing 2- CHH2 ( Site 0060)

Portland, Oregon 97239, United States

Allegheny Health Network ( Site 0042)

Pittsburgh, Pennsylvania 15212, United States

Thompson Cancer Survival Center ( Site 0696)

Knoxville, Tennessee 37916, United States

Utah Cancer Specialists ( Site 0697)

Salt Lake City, Utah 84106, United States

Cancer Care Northwest - Spokane Valley ( Site 0036)

Spokane Valley, Washington 99216, United States

University of Wisconsin Hospital and Clinics ( Site 0033)

Madison, Wisconsin 53792, United States

Instituto Medico Alexander Fleming ( Site 0063)

Buenos Aires, Buenos Aires F.D. C1426ANZ, Argentina

Fundacion Favaloro ( Site 0061)

Ciudad de Buenos Aires, Buenos Aires F.D. C1093AAS, Argentina

Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0066)

Buenos Aires, C1264AAA, Argentina

CEMIC ( Site 0064)

Buenos Aires, C1431FWO, Argentina

UCL Saint Luc ( Site 0162)

Brussels, Bruxelles-Capitale, Region de 1200, Belgium

UZ Gent ( Site 0163)

Ghent, Oost-Vlaanderen 9000, Belgium

UZ Leuven ( Site 0161)

Leuven, Vlaams-Brabant 3000, Belgium

AZ Delta ( Site 0165)

Roeselare, West-Vlaanderen 8800, Belgium

ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0088)

Ijuí, Rio Grande do Sul 98700-000, Brazil

Hospital Nossa Senhora da Conceicao ( Site 0087)

Porto Alegre, Rio Grande do Sul 91350-200, Brazil

Clinica de Oncologia Reichow ( Site 0085)

Blumenau, Santa Catarina 89010-340, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0081)

São Paulo, 01246-000, Brazil

Cross Cancer Institute ( Site 0010)

Edmonton, Alberta T6G 1Z2, Canada

CancerCare Manitoba ( Site 0002)

Winnipeg, Manitoba R3E 0V9, Canada

The Ottawa Hospital - Cancer Care ( Site 0008)

Ottawa, Ontario K1H 8L6, Canada

Sunnybrook Research Institute ( Site 0012)

Toronto, Ontario M4N 3M5, Canada

Princess Margaret Cancer Centre ( Site 0011)

Toronto, Ontario M5G 2M9, Canada

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0005)

Montreal, Quebec H2X 0A9, Canada

Centro Investigación del Cáncer James Lind ( Site 0106)

Temuco, Araucania 4800827, Chile

Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0103)

Temuco, Araucania 4810218, Chile

Hospital Regional de Concepcion ( Site 0105)

Concepción, Biobio 4070038, Chile

Centro de Cancer Nuestra Senora de la Esperanza ( Site 0104)

Santiago, Region M. de Santiago 8330024, Chile

Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)

Hefei, Anhui 230071, China

The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si

Fuzhou, Fujian 350025, China

The First Affiliated Hospital of Xiamen University ( Site 0538)

Xiamen, Fujian 361003, China

Hubei Cancer Hospital ( Site 0514)

Wuhan, Hubei 430079, China

Hunan Cancer Hospital ( Site 0515)

Changsha, Hunan 410006, China

Huai an First People s Hospital ( Site 0526)

Huai'an, Jiangsu 223001, China

Jiangsu Cancer Hospital ( Site 0519)

Nanjing, Jiangsu 210000, China

The Affiliated Hospital of Xuzhou Medical University ( Site 0522)

Xuzhou, Jiangsu 221002, China

Affiliated Hospital of Jiangsu University ( Site 0524)

Zhenjiang, Jiangsu 212000, China

Jiangxi Cancer Hospital ( Site 0512)

Nanchang, Jiangxi 330029, China

Shanghai Chest Hospital ( Site 0501)

Shanghai, Shanghai Municipality 200030, China

Shanghai Chest Hospital ( Site 0503)

Shanghai, Shanghai Municipality 200030, China

Zhongshan Hospital Fudan University ( Site 0502)

Shanghai, Shanghai Municipality 200032, China

Sichuan Cancer Hospital ( Site 0527)

Chengdu, Sichuan 610041, China

Tianjin Medical University Cancer Institute & Hospital ( Site 0505)

Tianjin, Tianjin Municipality 300060, China

Hangzhou First People's Hospital ( Site 0530)

Hangzhou, Zhejiang 310002, China

Sir Run Run Shaw Hospital ( Site 0523)

Hangzhou, Zhejiang 310018, China

Zhejiang Cancer Hospital ( Site 0529)

Hangzhou, Zhejiang 310022, China

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0721)

Brno, Brno-mesto 656 53, Czechia

Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0719)

Ostrava, Moravian-Silesian Region 708 52, Czechia

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0720)

Olomouc, Olomouc Region 779 00, Czechia

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0718)

Prague, Praha 5 150 06, Czechia

Rigshospitalet ( Site 0199)

Copenhagen, Capital Region 2100, Denmark

Odense Universitetshospital ( Site 0200)

Odense, Region Syddanmark 5000, Denmark

SA Pohja-Eesti Regionaalhaigla ( Site 0201)

Tallinn, Harju 13419, Estonia

SA Tartu Ulikooli Kliinikum ( Site 0202)

Tartu, Tartu 50406, Estonia

Institut De Cancerologie De Lorraine ( Site 0222)

Vandœuvre-lès-Nancy, Ain 54519, France

Centre Francois Baclesse ( Site 0236)

Caen, Calvados 14075, France

Centre Georges Francois Leclerc ( Site 0223)

Dijon, Cote-d Or 21079, France

CHU Limoges Hopital Dupuytren ( Site 0225)

Limoges, Haute-Vienne 87042, France

Institut Curie - Centre Rene Huguenin ( Site 0237)

Saint-Cloud, Hauts-de-Seine 92210, France

Institut Jean Godinot ( Site 0238)

Reims, Marne 51726 CEDEX, France

CHU Hotel Dieu Nantes ( Site 0230)

Nantes, Pays de la Loire Region 44093, France

Institut Sainte Catherine ( Site 0228)

Avignon, Provence-Alpes-Côte d'Azur Region 84918, France

CHU Amiens Picardie Site Sud Amiens ( Site 0235)

Amiens, Somme 80054, France

CHD Vendee ( Site 0227)

La Roche-sur-Yon, Vendee 85925, France

Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)

Stuttgart, Baden-Wurttemberg 70199, Germany

Universitaetsklinikum Koeln ( Site 0251)

Cologne, North Rhine-Westphalia 50937, Germany

Universitaetsklinikum Muenster ( Site 0248)

Münster, North Rhine-Westphalia 48149, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)

Mainz, Rhineland-Palatinate 55131, Germany

Charite Campus Virchow Klinikum ( Site 0250)

Berlin, 13353, Germany

Facharztzentrum Eppendorf ( Site 0242)

Hamburg, 20249, Germany

Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0122)

Guatemala City, 01010, Guatemala

Gastrosoluciones ( Site 0126)

Guatemala City, 01010, Guatemala

Oncomedica ( Site 0125)

Guatemala City, 01010, Guatemala

Grupo Medico Angeles ( Site 0121)

Guatemala City, 01015, Guatemala

Medi-K Cayala ( Site 0124)

Guatemala City, 01016, Guatemala

Centro Medico Integral De Cancerología (CEMIC) ( Site 0123)

Quetzaltenango, 09002, Guatemala

Pamela Youde Nethersole Eastern Hospital ( Site 0543)

Hong Kong, Hong Kong

Princess Margaret Hospital. ( Site 0542)

Hong Kong, Hong Kong

Queen Mary Hospital ( Site 0541)

Pokfulam, Hong Kong

Pecsi Tudomanyegyetem AOK ( Site 0265)

Pécs, Baranya 7624, Hungary

Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0262)

Gyula, Bekes County 5700, Hungary

Orszagos Onkologiai Intezet ( Site 0263)

Budapest, 1122, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 0261)

Debrecen, 4032, Hungary

Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)

Pavia, Lombardy 27100, Italy

IRCCS Policlinico San Donato ( Site 0295)

San Donato Milanese, Milano 20097, Italy

Azienda Ospedaliero Universitaria Pisana - Presidio Santa Chiara ( Site 0294)

Pisa, Tuscany 56126, Italy

ASST Papa Giovanni XXIII ( Site 0296)

Bergamo, 24127, Italy

Azienda Socio Sanitaria Territoriale di Cremona ( Site 0299)

Cremona, 26100, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0292)

Milan, 20133, Italy

Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Oncologia Clinica Sperimentale Addome ( Site 0

Naples, 80131, Italy

IRCCS Istituto Oncologico Veneto ( Site 0298)

Padova, 35128, Italy

Policlinico Universitario A. Gemelli ( Site 0297)

Roma, 00168, Italy

Aichi Cancer Center Hospital ( Site 0563)

Nagoya, Aichi-ken 464-8681, Japan

National Cancer Center Hospital East ( Site 0562)

Kashiwa, Chiba 2778577, Japan

Kanagawa Cancer Center ( Site 0565)

Yokohama, Kanagawa 241-8515, Japan

Saitama Cancer Center ( Site 0564)

Kitaadachi-gun, Saitama 362-0806, Japan

Shizuoka Cancer Center Hospital and Research Institute ( Site 0566)

Sunto-gun, Shizuoka 411-8777, Japan

National Cancer Center Hospital ( Site 0561)

Tokyo, 104-0045, Japan

Cryptex Investigación Clínica S.A. de C.V. ( Site 0729)

Cuauhtémoc, Ciudad de México, Mexico City 06100, Mexico

CENTRO HEMATO ONCOLOGICO PRIVADO-CHOP ( Site 0728)

Toluca, 50120, Mexico

Instituto Nacional de Enfermedades Neoplasicas ( Site 0141)

Lima, Muni Metro de Lima Lima 34, Peru

Detecta Clínica ( Site 0146)

Surquillo, Muni Metro de Lima 15038, Peru

Hospital Nacional Arzobispo Loayza ( Site 0143)

Lima, 15082, Peru

Clinica San Gabriel ( Site 0142)

Lima, 15087, Peru

Baguio General Hospital and Medical Center ( Site 0603)

Baguio City, Benguet 2600, Philippines

Cebu Doctors University Hospital ( Site 0604)

Cebu City, Cebu 6000, Philippines

The Medical City-Iloilo ( Site 0602)

Iloilo City, Iloilo 5000, Philippines

St. Luke s Medical Center ( Site 0601)

Quezon City, National Capital Region 1102, Philippines

Hospital Beatriz Angelo ( Site 0374)

Loures, Lisbon District 2674-514, Portugal

Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0372)

Lisbon, 1099-023, Portugal

Hospital da Luz ( Site 0373)

Lisbon, 1500 650, Portugal

CHLN Hospital Santa Maria ( Site 0376)

Lisbon, 1649-035, Portugal

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0371)

Porto, 4200-072, Portugal

MedEuropa Bucuresti - Centru de Radioterapie-Oncology ( Site 0400)

Bucharest, Bucharest 022343, Romania

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0392)

Cluj-Napoca, Cluj 400015, Romania

S.C. Radiotherapy Center Cluj S.R.L ( Site 0391)

Cluj-Napoca, Cluj 407280, Romania

Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 0393)

Ovidiu, Constanța County 905900, Romania

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0394)

Craiova, Dolj 200542, Romania

Centrul Medical Topmed ( Site 0398)

Târgu Mureş, Mureș County 540156, Romania

S.C.Focus Lab Plus S.R.L ( Site 0395)

Bucharest, 022548, Romania

GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0430)

Ufa, Baskortostan, Respublika 450054, Russia

Kaluga Regional Clinical Oncology Center ( Site 0424)

Kaluga, Kaluzskaja Oblast 248007, Russia

Main Military Clinical Hospital n.a. N.N.Burdenko ( Site 0421)

Moscow, Moscow 105229, Russia

FSAI Treatment and Rehabilitation Centre of the MoH and SD of RF ( Site 0429)

Moscow, Moscow 125367, Russia

SBHI Samara Regional Clinical Oncology Dispensary ( Site 0420)

Samara, Samara Oblast 443031, Russia

Pavlov First Saint Petersburg State Medical University ( Site 0426)

Saint Petersburg, Sankt-Peterburg 197022, Russia

Medical institute named after Berezin Sergey ( Site 0417)

Saint Petersburg, Sankt-Peterburg 197758, Russia

Sverdlovsk Regional Oncology Hospital ( Site 0411)

Yekaterinburg, Sverdlovsk Oblast 620036, Russia

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 0412)

Kazan', Tatarstan, Respublika 420029, Russia

Chonnam National University Hwasun Hospital ( Site 0625)

Hwasun Gun, Jeonranamdo 58128, South Korea

National Cancer Center ( Site 0626)

Goyang-si, Kyonggi-do 10408, South Korea

Asan Medical Center ( Site 0623)

Songpagu, Seoul 05505, South Korea

Severance Hospital Yonsei University Health System ( Site 0624)

Seoul, 03722, South Korea

Samsung Medical Center ( Site 0622)

Seoul, 06351, South Korea

Korea University Guro Hospital ( Site 0621)

Seoul, 08308, South Korea

Chang Gung Med Foundation. Kaohsiung Branch ( Site 0643)

Kaohsiung City, 833, Taiwan

China Medical University Hospital ( Site 0646)

Taichung, 40447, Taiwan

Taichung Veterans General Hospital-Radiation Oncology ( Site 0647)

Taichung, 407, Taiwan

National Cheng Kung University Hospital ( Site 0645)

Tainan, 70457, Taiwan

National Taiwan University Hospital ( Site 0641)

Taipei, 10002, Taiwan

Koo Foundation Sun Yat-Sen Cancer Center ( Site 0644)

Taipei, 11259, Taiwan

Chang Gung Medical Foundation. Linkou ( Site 0642)

Taoyuan, 33305, Taiwan

Istanbul University Cerrahpasa Medical Faculty ( Site 0452)

Istanbul, Istanbul 34098, Turkey (Türkiye)

Memorial Ankara Hastanesi ( Site 0461)

Ankara, 06520, Turkey (Türkiye)

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0451)

Istanbul, 34722, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi ( Site 0457)

Izmir, 35040, Turkey (Türkiye)

Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 0458)

Izmir, 35360, Turkey (Türkiye)

Aberdeen Royal Infirmary ( Site 0474)

Aberdeen, Aberdeen City AB25 2ZN, United Kingdom

Cambridge University Hospitals NHS Trust ( Site 0477)

Cambridge, Cambridgeshire CB2 0QQ, United Kingdom

Royal Free Hospital ( Site 0702)

London, England NW32QG, United Kingdom

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0283)

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

Hammersmith Hospital-Medical Oncology ( Site 0471)

London, London, City of W12 OHS, United Kingdom

Nottingham University Hospitals NHS Trust ( Site 0476)

Nottingham, Nottinghamshire NG5 1PB, United Kingdom

Royal Marsden Hospital (Sutton) ( Site 0281)

Sutton, Surrey SM2 5PT, United Kingdom

University College Hospital NHS Foundation Trust ( Site 0701)

London, Worcestershire NW1 2PG, United Kingdom

The Christie NHS Foundation Trust ( Site 0282)

Manchester, M20 4BX, United Kingdom

Mount Vernon Hospital ( Site 0478)

Northwood, HA6 2RN, United Kingdom