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NCT04210115

PHASE3

Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of treatment with definitive chemoradiotherapy (dCRT) + pembrolizumab (MK-3475) compared to treatment with dCRT + placebo with respect to Event-free Survival (EFS) and Overall Survival (OS) in: * participants whose tumors express Programmed Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10 * participants whose tumors express PD-L1 CPS ≥1 * all participants The primary study hypotheses are that dCRT+ pembrolizumab is better than dCRT + placebo with respect to: * EFS in participants whose tumors express PD-L1 CPS ≥10 * EFS in participants whose tumors express PD-L1 CPS ≥1 * EFS in all participants * OS in participants whose tumors express PD-L1 CPS ≥10 * OS in participants whose tumors express PD-L1 CPS ≥1 * OS in all participants

Official title: A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

703

Start Date

2020-02-28

Completion Date

2026-06-26

Last Updated

2026-10-30

Healthy Volunteers

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)Gastroesophageal Junction Carcinoma (GEJC)Esophageal Adenocarcinoma (EAC)

Interventions

BIOLOGICAL

pembrolizumab

IV infusion

DRUG

placebo

IV infusion

DRUG

cisplatin

IV infusion

DRUG

5-FU

IV infusion

RADIATION

radiotherapy

external radiation

DRUG

leucovorin

IV infusion

DRUG

levoleucovorin

IV infusion

DRUG

oxaliplatin

IV infusion

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

Locations (170)

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

Long Beach, California, United States

Columbus Regional Research Institute ( Site 0047)

Columbus, Georgia, United States

University of Kansas Cancer Center ( Site 0023)

Westwood, Kansas, United States

Cancer Center of Kansas ( Site 0058)

Wichita, Kansas, United States

University Medical Center ( Site 0035)

New Orleans, Louisiana, United States

Greater Baltimore Medical Center ( Site 0031)

Baltimore, Maryland, United States

Dana Farber Cancer Center ( Site 0034)

Boston, Massachusetts, United States

Henry Ford Hospital ( Site 0685)

Detroit, Michigan, United States

University of Missouri ( Site 0688)

Columbia, Missouri, United States

Renown Regional Medical Center ( Site 0706)

Reno, Nevada, United States

Rutgers Cancer Institute of New Jersey ( Site 0695)

New Brunswick, New Jersey, United States

Weill Cornell Medical College ( Site 0053)

New York, New York, United States

Stephenson Cancer Center ( Site 0044)

Oklahoma City, Oklahoma, United States

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

Portland, Oregon, United States

Allegheny Health Network ( Site 0042)

Pittsburgh, Pennsylvania, United States

Thompson Cancer Survival Center ( Site 0696)

Knoxville, Tennessee, United States

Utah Cancer Specialists ( Site 0697)

Salt Lake City, Utah, United States

Cancer Care Northwest - Spokane Valley ( Site 0036)

Spokane Valley, Washington, United States

University of Wisconsin Hospital and Clinics ( Site 0033)

Madison, Wisconsin, United States

Instituto Medico Alexander Fleming ( Site 0063)

Buenos Aires, Buenos Aires F.D., Argentina

Fundacion Favaloro ( Site 0061)

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

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

Buenos Aires, Argentina

CEMIC ( Site 0064)

Buenos Aires, Argentina

UCL Saint Luc ( Site 0162)

Brussels, Bruxelles-Capitale, Region de, Belgium

UZ Gent ( Site 0163)

Ghent, Oost-Vlaanderen, Belgium

UZ Leuven ( Site 0161)

Leuven, Vlaams-Brabant, Belgium

AZ Delta ( Site 0165)

Roeselare, West-Vlaanderen, Belgium

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

Ijuí, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceicao ( Site 0087)

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Oncologia Reichow ( Site 0085)

Blumenau, Santa Catarina, Brazil

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

São Paulo, Brazil

Cross Cancer Institute ( Site 0010)

Edmonton, Alberta, Canada

CancerCare Manitoba ( Site 0002)

Winnipeg, Manitoba, Canada

The Ottawa Hospital - Cancer Care ( Site 0008)

Ottawa, Ontario, Canada

Sunnybrook Research Institute ( Site 0012)

Toronto, Ontario, Canada

Princess Margaret Cancer Centre ( Site 0011)

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

Centro Investigación del Cáncer James Lind ( Site 0106)

Temuco, Araucania, Chile

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

Temuco, Araucania, Chile

Hospital Regional de Concepcion ( Site 0105)

Concepción, Biobio, Chile

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

Santiago, Region M. de Santiago, Chile

Anhui Provincial Hospital-Oncology Radiotherapy Department ( Site 0531)

Hefei, Anhui, China

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

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University ( Site 0538)

Xiamen, Fujian, China

Hubei Cancer Hospital ( Site 0514)

Wuhan, Hubei, China

Hunan Cancer Hospital ( Site 0515)

Changsha, Hunan, China

Huai an First People s Hospital ( Site 0526)

Huai'an, Jiangsu, China

Jiangsu Cancer Hospital ( Site 0519)

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University ( Site 0522)

Xuzhou, Jiangsu, China

Affiliated Hospital of Jiangsu University ( Site 0524)

Zhenjiang, Jiangsu, China

Jiangxi Cancer Hospital ( Site 0512)

Nanchang, Jiangxi, China

Shanghai Chest Hospital ( Site 0501)

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital ( Site 0503)

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Fudan University ( Site 0502)

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital ( Site 0527)

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital ( Site 0505)

Tianjin, Tianjin Municipality, China

Hangzhou First People's Hospital ( Site 0530)

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital ( Site 0523)

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital ( Site 0529)

Hangzhou, Zhejiang, China

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

Brno, Brno-mesto, Czechia

Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0719)

Ostrava, Moravian-Silesian Region, Czechia

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0720)

Olomouc, Olomouc Region, Czechia

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

Prague, Praha 5, Czechia

Rigshospitalet ( Site 0199)

Copenhagen, Capital Region, Denmark

Odense Universitetshospital ( Site 0200)

Odense, Region Syddanmark, Denmark

SA Pohja-Eesti Regionaalhaigla ( Site 0201)

Tallinn, Harju, Estonia

SA Tartu Ulikooli Kliinikum ( Site 0202)

Tartu, Tartu, Estonia

Institut De Cancerologie De Lorraine ( Site 0222)

Vandœuvre-lès-Nancy, Ain, France

Centre Francois Baclesse ( Site 0236)

Caen, Calvados, France

Centre Georges Francois Leclerc ( Site 0223)

Dijon, Cote-d Or, France

CHU Limoges Hopital Dupuytren ( Site 0225)

Limoges, Haute-Vienne, France

Institut Curie - Centre Rene Huguenin ( Site 0237)

Saint-Cloud, Hauts-de-Seine, France

Institut Jean Godinot ( Site 0238)

Reims, Marne, France

CHU Hotel Dieu Nantes ( Site 0230)

Nantes, Pays de la Loire Region, France

Institut Sainte Catherine ( Site 0228)

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

CHU Amiens Picardie Site Sud Amiens ( Site 0235)

Amiens, Somme, France

CHD Vendee ( Site 0227)

La Roche-sur-Yon, Vendee, France

Marienhospital Stuttgart Vincenz von Paul Kliniken gGmbH ( Site 0253)

Stuttgart, Baden-Wurttemberg, Germany

Universitaetsklinikum Koeln ( Site 0251)

Cologne, North Rhine-Westphalia, Germany

Universitaetsklinikum Muenster ( Site 0248)

Münster, North Rhine-Westphalia, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 0247)

Mainz, Rhineland-Palatinate, Germany

Charite Campus Virchow Klinikum ( Site 0250)

Berlin, Germany

Facharztzentrum Eppendorf ( Site 0242)

Hamburg, Germany

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

Guatemala City, Guatemala

Gastrosoluciones ( Site 0126)

Guatemala City, Guatemala

Oncomedica ( Site 0125)

Guatemala City, Guatemala

Grupo Medico Angeles ( Site 0121)

Guatemala City, Guatemala

Medi-K Cayala ( Site 0124)

Guatemala City, Guatemala

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

Quetzaltenango, 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, Hungary

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

Gyula, Bekes County, Hungary

Orszagos Onkologiai Intezet ( Site 0263)

Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont ( Site 0261)

Debrecen, Hungary

Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 0300)

Pavia, Lombardy, Italy

IRCCS Policlinico San Donato ( Site 0295)

San Donato Milanese, Milano, Italy

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

Pisa, Tuscany, Italy

ASST Papa Giovanni XXIII ( Site 0296)

Bergamo, Italy

And 70 more locations on ClinicalTrials.gov

Clinical Research Directory

Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (170)