Clinical Trial - NCT02743494

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Patients With Resected Esophageal or Gastroesophageal Junction Cancer

Recruiting

Sponsor: Bristol-Myers Squibb

Collaborators: Ono Pharmaceutical Co. Ltd

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02743494

Protocol Info

Short Description: NIVOLUMAB OR PLACEBO IN LOWER ESOPHAGEAL OR GEJ CANCER
Long Description: A Randomized, Multicenter, Double Blind, Phase III Study of Nivolumab or Placebo in Subjects with Resected Lower Esophageal, or Gastroesophageal Junction Cancer
MGH Status: Open
Sponsor: Bristol Myers Squibb
Disease Program: GI

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

The purpose of this study is to determine whether Nivolumab will improve overall survival, disease-free survival, or both compared with placebo.
Condition Title Intervention Phase
Advanced Cancer Nivolumab Placebo Phase 3
Study Type Interventional
Official Title A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

Primary Outcome Measures

Disease-Free Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery [Time Frame: Approximately 36 months after the first subject is randomized] [Designated as safety issue: ]

Overall Survival of adjuvant nivolumab in subjects with resected esophageal cancer or gastroesophageal junction cancer who have received chemoradiotherapy followed by surgery [Time Frame: Approximately 49 months after the first subject is randomized] [Designated as safety issue: ]


Secondary Outcome Measures

Overall survival rate [Time Frame: Overall survival rate at 1, 2, and 3 years] [Designated as safety issue: ]

Estimated Enrollment: 760
Study Start Date: May 2016
Estimated Study Completion Date: October 2024
Estimated Primary Completion Date: September 2020
Arms Assigned Interventions

Experimental:Nivolumab

Specified dose on specified days.
Drug:Nivolumab
Specified dose on specified days

Placebo Comparator:Placebo

Specified dose on specified days.
Other:Placebo
Specified dose on specified days

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
  • Completed pre-operative chemo radiotherapy followed by surgery
  • Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection

Exclusion Criteria:

  • Diagnosed with cervical esophageal carcinoma
  • Diagnosed with Stage IV resectable disease
  • Did not receive concurrent chemoradiotherapy prior to surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02743494

Locations

  • United States, Arizona
    • Local Institution Phoenix, Arizona, United States, 85016
    • Arizona Oncology Associates, PC - HOPE Tucson, Arizona, United States, 85711
  • United States, California
    • Univ. Of Southern Calif. /Norris Comprehensive Cancer Center Los Angeles, California, United States, 90033
    • Pacific Hematology Oncology Associates San Francisco, California, United States, 94115
    • Ucsf Cancer Center San Francisco, California, United States, 94158
  • United States, Colorado
    • University Of Colorado Aurora, Colorado, United States, 80045
    • Rocky Mountain Cancer Centers Denver, Colorado, United States, 80218
  • United States, District of Columbia
    • Georgetown University Med Ctr Washington, District of Columbia, United States, 20007
  • United States, Florida
    • University Of Miami Sylvester Comprehensive Cancer Center Coral Gables, Florida, United States, 33146
    • Florida Cancer Specialists Fort Myers, Florida, United States, 33916
    • Cancer Specialists of North FL Jacksonville, Florida, United States, 32256
    • Sacred Heart Medical Group Pensacola, Florida, United States, 32504
    • SCRI Florida Cancer Specialists North Saint Petersburg, Florida, United States, 33705
  • United States, Illinois
    • University Of Chicago Chicago, Illinois, United States, 60637
  • United States, Maryland
    • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Beth Israel Deaconess Medical Center Boston, Massachusetts, United States, 02215
    • Dana Farber Cancer Institute. Boston, Massachusetts, United States, 02215
    • Mass General/North Shore Cancer Center for Outpatient Care Boston, Massachusetts, United States, 02215
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02215
  • United States, Missouri
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
  • United States, New Jersey
    • Hackensack University Medical Center Hackensack, New Jersey, United States, 07601
    • Jersey Shore University Medical Center Neptune, New Jersey, United States, 07753
  • United States, New York
    • Albert Einstein Cancer Center At The Montefiore Medical Park Bronx, New York, United States, 10461
    • NYU Langone Medical Center New York, New York, United States, 10016
  • United States, North Carolina
    • Levine Cancer Institute Charlotte, North Carolina, United States, 28204
    • Duke Cancer Center Durham, North Carolina, United States, 27710
  • United States, North Dakota
    • Local Institution Fargo, North Dakota, United States, 58122
  • United States, Ohio
    • University Hospitals of Cleveland Cleveland, Ohio, United States, 44106
  • United States, Oklahoma
    • Local Institution Oklahoma City, Oklahoma, United States, 73104
  • United States, Oregon
    • Oregon Health & Sci Univ Portland, Oregon, United States, 97239-3098
  • United States, Pennsylvania
    • Lehigh Valley Hospital Allentown, Pennsylvania, United States, 18103
    • Fox Chase Cancer Center Philadelphia, Pennsylvania, United States, 19111-2412
    • Allegheny Health Network Pittsburgh, Pennsylvania, United States, 15224
  • United States, South Dakota
    • Local Institution Sioux Falls, South Dakota, United States, 57104
  • United States, Tennessee
    • Sarah Cannon Research Institute Nashville, Tennessee, United States, 37203
    • Vanderbilt University Med Ctr Nashville, Tennessee, United States, 37232
  • United States, Texas
    • Dallas VA Medical Center Dallas, Texas, United States, 75216
    • Baylor Charles A. Sammons Cancer Center Dallas, Texas, United States, 75246
    • Local Institution Dallas, Texas, United States, 75246
    • The University Of Texas MD Anderson Cancer Center Houston, Texas, United States, 77030
    • Scott & White Memorial Hospital And Clinic Temple, Texas, United States, 76508
  • United States, Washington
    • Virginia Mason Medical Center Seattle, Washington, United States, 98101
    • University of Washington Seattle, Washington, United States, 98109
  • United States, Wisconsin
    • University Of Wisconsin Madison, Wisconsin, United States, 53792-0001
  • Argentina, Buenos Aires
    • Hospital Municipal De Gastroenterologia Dr.Udaondo Capital Federal, Buenos Aires, Argentina, 1264
    • Local Institution Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, 1118
  • Argentina, RIO Negro
    • Clinica Viedma S.A. Viedma, RIO Negro, Argentina, 8500
  • Argentina, Santa FE
    • Hospital Provincial Del Centenario Rosario, Santa FE, Argentina, 2000
  • Argentina, Tucuman
    • Centro Para La Atencion Integral Del Paciente Oncologico San Miguel De Tucuman, Tucuman, Argentina, 4000
  • Argentina,
    • Fundacion Favaloro Buenos Aires, , Argentina, 1093 AAS
    • Hospital Britanico Buenos Aires, , Argentina, 1280
    • Instituto Medico Especialazado Alexander Fleming Caba, , Argentina, 1426
    • Instituto Oncologico De Cordoba Cordoba, , Argentina, X5006HBF
  • Australia, New South Wales
    • Local Institution Blacktown, New South Wales, Australia, 2148
    • Local Institution Gosford, New South Wales, Australia, 2250
    • Royal North Shore Hospital St Leonards, New South Wales, Australia, 2065
    • Local Institution Tamworth, New South Wales, Australia, 2340
  • Australia, Queensland
    • Local Institution Brisbane, Queensland, Australia, 4102
  • Australia, South Australia
    • Royal Adelaide Hospital Adelaide, South Australia, Australia, 5000
  • Australia, Tasmania
    • Royal Hobart Hospital Hobart, Tasmania, Australia, 7000
  • Australia, Victoria
    • Monash Medical Centre Clayton Clayton, Victoria, Australia, 3168
  • Australia, Western Australia
    • Local Institution Perth, Western Australia, Australia, 6150
  • Belgium,
    • Local Institution Bruxelles, , Belgium, 1200
    • Local Institution Edegem, , Belgium, 2650
    • Local Institution Gent, , Belgium, B-9000
    • Local Institution Leuven, , Belgium, 3000
    • Local Institution Liege, , Belgium, 4000
    • Local Institution Namur, , Belgium, 5000
  • Brazil, Distrito Federal
    • Hospital Sirio Libanes Brasilia, Distrito Federal, Brazil, 70200-730
  • Brazil, Minas Gerais
    • PERSONAL Oncologia de Precisao e Personalizada Belo Horizonte, Minas Gerais, Brazil, 30130-090
  • Brazil, Parana
    • Liga Paranaense De Combate Ao Cancer Erasto Gaertner Curitiba, Parana, Brazil, 81520-060
  • Brazil, RIO Grande DO SUL
    • Associacao Hospital de Caridade Ijui Ijui, RIO Grande DO SUL, Brazil, 98700-000
    • Hospital Sao Lucas Da Pucrs Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
  • Brazil, Santa Catarina
    • Centro de Pesquisas Oncologicas de Santa Catarina-CEPON Itacorubi, Florianopolis, Santa Catarina, Brazil, 88034
  • Brazil, SAO Paulo
    • Fundacao Pio Xii Hosp Cancer De Barretos Barretos, SAO Paulo, Brazil, 14780-070
    • Hospital De Base De Sao Jose Do Rio Preto Sao Jose De Rio Preto, SAO Paulo, Brazil, 15091-000
  • Brazil,
    • COI Clinicas Oncologicas Integradas SA Rio de Janeiro, , Brazil, 22793-080
    • Nucleo De Oncologia Da Bahia Salvador, , Brazil,
    • Local Institution Sao Paulo, , Brazil, 01246-000
    • Hospital Sirio Libanes Sao Paulo, , Brazil, 01308-050
  • Canada, Alberta
    • Cross Cancer Institute Edmonton, Alberta, Canada, T6G 1Z2
  • Canada, British Columbia
    • British Columbia Cancer Agency-Vancouver Ctr Vancouver, British Columbia, Canada, V5Z 4E6
  • Canada, Nova Scotia
    • Nova Scotia Health Authority QEII Health Sciences Centre Halifax, Nova Scotia, Canada, B3H 1V7
  • Canada, Ontario
    • London Regional Cancer Program London, Ontario, Canada, N6A 4L6
    • Local Institution Toronto, Ontario, Canada, M5G 2M9
  • Canada, Quebec
    • Montreal General Hospital Montreal, Quebec, Canada, H4A 3J1
    • Local Institution Ottawa, Quebec, Canada, K1H 8L6
    • Local Institution Trois-Rivieres, Quebec, Canada, G8Z 3R9
  • Canada,
    • Hotel Dieu De Quebec Quebec, , Canada, G1R 2J6
  • China, Beijing
    • Local Institution Beijing, Beijing, China, 100142
  • China, Fujian
    • Local Institution Fuzhou, Fujian, China, 350014
  • China, Guangdong
    • Local Institution Guangzhou, Guangdong, China, 510060
  • China, Shanghai
    • Local Institution Shanghai, Shanghai, China, 200030
    • Local Institution Shanghai, Shanghai, China, 200032
  • China, Zhejiang
    • Local Institution Hangzhou, Zhejiang, China, 310003
    • Local Institution Hangzhou, Zhejiang, China, 310022
    • Local Institution Linhai, Zhejiang, China, 317000
  • China,
    • Local Institution Changsha, , China,
    • Local Institution Shanghai, , China, 200032
    • Local Institution Tianjin, , China, 300060
  • Czechia,
    • Klinika komplexni onkologicke pece Brno, , Czechia, 656 53
    • Klinika onkologie a radioterapie Hradec Kralove, , Czechia, 500 05
    • Onkologicka klinika Olomouc, , Czechia, 779 00
  • Denmark,
    • Local Institution Aarhus N, , Denmark, 8200
  • France,
    • Local Institution Avignon Cedes 9, , France, 84918
    • Local Institution Dijon Cedex, , France, 21079
    • Local Institution LILLE Cedex, , France, 59037
    • Local Institution Paris, , France, 75012
    • Local Institution Pessac, , France, 33604
    • Local Institution Pierre Benite Cedex, , France, 69495
    • Local Institution Rennes Cedex 9, , France, 35033
    • Local Institution Rouen, , France, 76000
    • Local Institution Toulouse, , France, 31403
  • Germany,
    • Charite Campus Virchow Klinikum Berlin, , Germany, 13353
    • Kliniken Essen-Mitte/Huyssens-Stift Essen, , Germany, 45136
    • Local Institution Hamburg, , Germany, 20251
    • University Hospital Of Cologne Koeln, , Germany, 50937
    • Johannes -Gutenberg Universitat Mainz, , Germany, 55131
    • Universitaets-Klinikum Marburg Marburg, , Germany, 35043
    • Klinikum Rechts Der Isar Munich, , Germany, 81675
    • Universitaetsklinikum Tuebingen Tuebingen, , Germany, 72076
  • Hong Kong,
    • Local Institution Hong Kong, , Hong Kong,
  • Hungary,
    • Local Institution Budapest, , Hungary, 1097
    • Orszagos Onkologiai Intezet Budapest, , Hungary, 1122
    • DE KK Onkologiai Intezet Debrecen, , Hungary,
    • Local Institution Kaposvar, , Hungary, 7400
  • Ireland, Cork
    • Local Institution Wilton, Cork, Ireland,
  • Ireland,
    • Local Institution Dublin, , Ireland, 9
    • Local Institution Galway, , Ireland,
  • Israel,
    • Local Institution Haifa, , Israel, 31096
    • Local Institution Jerusalem, , Israel, 91120
    • Local Institution Petach Tikva, , Israel, 49100
    • Local Institution Ramat-gan, , Israel, 52621
    • Local Institution Tel Aviv, , Israel, 64239
  • Italy,
    • ASST Papa Giovanni XXIII Bergamo, , Italy, 24127
    • Policlinico San Donato Milano, , Italy, 20097
    • IRCCS Istituto Nazionale Tumori Milano Milano, , Italy, 20133
    • Arcispedale S. Maria Nuova - A.O. Reggio Emilia Reggio Emilia, , Italy, 42100
    • Fondazione Policlinico Universitario A. Gemelli Roma, , Italy, 00168
  • Japan, Akita
    • Local Institution Akita-Shi, Akita, Japan, 0108543
  • Japan, Chiba
    • Local Institution Chiba-shi, Chiba, Japan, 2608677
  • Japan, Fukuoka
    • Local Institution Fukuoka-shi, Fukuoka, Japan, 8128582
  • Japan, Gifu
    • Local Institution Gifu-shi, Gifu, Japan, 5011194
  • Japan, Hiroshima
    • Local Institution Hiroshima-Shi, Hiroshima, Japan, 7348551
  • Japan, Hokkaido
    • Local Institution Sapporo-shi, Hokkaido, Japan, 0030027
    • Local Institution Sapporo-shi, Hokkaido, Japan, 0608648
  • Japan, Kagoshima
    • Local Institution Kagoshima-shi, Kagoshima, Japan, 8908520
  • Japan, Kumamoto
    • Local Institution Kumamoto-shi, Kumamoto, Japan, 8608556
  • Japan, Miyagi
    • Local Institution Sendai-shi, Miyagi, Japan, 9808574
  • Japan, Osaka
    • Local Institution Osaka-sayama-shi, Osaka, Japan, 5898511
    • Local Institution Suita-shi, Osaka, Japan, 5650871
  • Japan, Saitama
    • Local Institution Kitaadachi-gun, Saitama, Japan, 3620806
  • Japan, Tokyo
    • Local Institution Chuo-ku, Tokyo, Japan, 1040045
    • Local Institution Koto-ku, Tokyo, Japan, 1358550
    • Local Institution Minato-ku, Tokyo, Japan, 1058470
    • Local Institution Shinjuku-ku, Tokyo, Japan, 1600023
    • Local Institution Shinjuuku-ku, Tokyo, Japan, 1608582
  • Japan,
    • Local Institution Fukuoka, , Japan, 8111395
    • Local Institution Kita-gun, , Japan, 7610793
  • Korea, Republic of,
    • Local Institution Seoul, , Korea, Republic of, 03722
    • Local Institution Seoul, , Korea, Republic of, 05505
  • Mexico, Chiapas
    • Centro de Estudios y Prevencion Del Cancer, AC Tuxtla Gutierrez, Chiapas, Mexico, 29038
  • Mexico, Distrito Federal C.P.
    • Instituto Nacional De Cancerologia Tlalpan, Distrito Federal C.P., Mexico, 14000
  • Mexico, Guanajuato
    • Fundacion Rodolfo Padilla Padilla A.C. Leon de los Aldama, Guanajuato, Mexico, 37000
  • Mexico,
    • Hospital Cardiologica De Aguascalientes Aguascalientes, , Mexico, 20230
    • Supere Centro de Infusion S.A de C.V. Ciudad de Mexico, , Mexico, 06760
    • Instituto Nacional De Ciencias Medicas Y Nutricion S.Z. Distrito Federal, , Mexico, 14080
  • Netherlands,
    • Local Institution Amsterdam, , Netherlands, 1066 CX
    • Local Institution Groningen, , Netherlands, 9713 AP
    • Local Institution Maastrict, , Netherlands, 6229 HX
  • Peru,
    • Hospital Nacional Daniel Alcides Carrion Callao, , Peru, 02
    • Instituto Nacional De Enfermedades Neoplasicas Lima, , Peru, 34
    • Hospital Nacional Cayetano Heredia Lima, , Peru, LIMA 31
    • Oncosalud Sac Lima, , Peru, LIMA 41
    • Local Institution Lima, , Peru,
  • Poland,
    • II Klinika Radioterapii i Chemioterapii Gliwice, , Poland, 44-101
    • Oddzial Kliniczny Chirurgii Klatki Piersiowej Krakow, , Poland, 31-202
    • II Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego Lublin, , Poland, 20-081
    • Oddzial Onkologii Klinicznej i Doswiadczalnej Poznan, , Poland, 60-780
    • Klinika Gastroenterologii Onkologicznej Warszawa, , Poland, 02-781
  • Puerto Rico,
    • Local Institution San Juan, , Puerto Rico, 00927
  • Romania,
    • SC Oncopremium Team SRL Baia Mare, , Romania, 430295
    • Fundeni Clinical Institute Gastroenterology; Hepatology Clin Bucharest, , Romania, 022328
    • Focus Lab Plus SRL Bucuresti, , Romania, 021389
    • Bendis Clinic Srl Cluj-napoca, , Romania, 400352
    • Sf. Nectarie Oncology Center Craiova, , Romania, 200347
    • S.C. Radiotherapy Center Cluj S.R.L. Floresti, , Romania, 407280
  • Russian Federation,
    • Local Institution Cheboksary, , Russian Federation, 428020
    • Local Institution Moscow, , Russian Federation, 115478
    • N.N. Blokhin National Medical Research Center of Oncology Moscow, , Russian Federation, 115478
    • Local Institution Moscow, , Russian Federation, 125367
    • Saint-Petersburg Medical University Named After I.P.Pavlov Saint-Petersburg, , Russian Federation, 197022
    • Local Institution St. Petersburg, , Russian Federation, 197758
  • Singapore,
    • Local Institution Singapore, , Singapore, 119228
    • Local Institution Singapore, , Singapore, 169610
  • Spain,
    • Local Institution Barcelona, , Spain, 08035
    • Local Institution Cordoba, , Spain, 14004
    • Local Institution Madrid, , Spain, 28007
    • Local Institution Madrid, , Spain, 28050
  • Switzerland,
    • Universitaetsspital Basel Basel, , Switzerland, 4031
    • Kantonsspital St Gallen St Gallen, , Switzerland, 9007
  • Taiwan,
    • Local Institution Taichung, , Taiwan, 40447
    • Local Institution Tainan, , Taiwan, 70403
    • Local Institution Taipei, , Taiwan, 100
  • Turkey,
    • Baskent University Adana Hospital Adana, , Turkey, 01250
    • Local Institution Ankara, , Turkey, 06500
    • Ataturk University Erzurum, , Turkey, 25240
    • Istanbul Universitesi Cerrahpasa Tip Fakultesi Onkoloji Istanbul, , Turkey, 34300
  • United Kingdom, Greater London
    • Local Institution London, Greater London, United Kingdom, NW1 2PG
    • Local Institution London, Greater London, United Kingdom, SE1 9RY
    • Local Institution London, Greater London, United Kingdom, SW3 6JJ
  • United Kingdom, Hampshire
    • Local Institution Southampton, Hampshire, United Kingdom, SO16 6YD
  • United Kingdom, Manchester
    • Local Institution Withington, Manchester, United Kingdom, M20 4BX
  • United Kingdom, Surrey
    • Local Institution Sutton, Surrey, United Kingdom, SM2 5PT
  • United Kingdom,
    • Local Institution Cardiff, , United Kingdom, CF14 2TL

Sponsors and Collaborators

Bristol-Myers Squibb

Ono Pharmaceutical Co. Ltd

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02743494
Other Study ID Numbers: 2015-005556-10
Study First Received:
Last Updated:
Health Authority:

Additional relevant MeSH terms:

Nivolumab

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on May 30, 2019