An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer (CheckMate 577)

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Cancer
• Intervention / Treatment: Other: Placebo; Drug: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 794
• Phase: Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1093 AAS
    • Local Institution - 0198
  • Caba, Argentina, 1426
    • Local Institution - 0133
  • Cordoba, Argentina, X5006HBF
    • Local Institution - 0112
  • Buenos Aires
    • Capital Federal, Buenos Aires, Argentina, 1264
      • Local Institution - 0050
    • Capital Federal, Buenos Aires, Argentina, 1280
      • Local Institution - 0152
  • Distrito Federal
    • Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina, 1118
      • Local Institution - 0164
  • RIO Negro
    • Viedma, RIO Negro, Argentina, 8500
      • Local Institution - 0207
  • Santa FE
    • Rosario, Santa FE, Argentina, 2000
      • Local Institution - 0208
  • Tucuman
    • San Miguel De Tucuman, Tucuman, Argentina, 4000
      • Local Institution - 0051
• Australia
  • Hobart, Australia, 7000
    • Local Institution - 0099
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Local Institution - 0200
    • Gosford, New South Wales, Australia, 2250
      • Local Institution - 0098
    • St Leonards, New South Wales, Australia, 2065
      • Local Institution - 0074
    • Tamworth, New South Wales, Australia, 2340
      • Local Institution - 0075
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Local Institution - 0237
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Local Institution - 0123
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Local Institution - 0072
  • Western Australia
    • Perth, Western Australia, Australia, 6150
      • Local Institution - 0156
• Belgium
  • Bruxelles, Belgium, 1200
    • Local Institution - 0035
  • Edegem, Belgium, 2650
    • Local Institution - 0037
  • Gent, Belgium, 9000
    • Local Institution - 0086
  • Leuven, Belgium, 3000
    • Local Institution - 0034
  • Liege, Belgium, 4000
    • Local Institution - 0036
  • Namur, Belgium, 5000
    • Local Institution - 0087
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Local Institution - 0065
  • Salvador, Brazil
    • Local Institution - 0064
  • Sao Paulo, Brazil, 01246-000
    • Local Institution - 0062
  • Sao Paulo, Brazil, 01308-050
    • Local Institution - 0063
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 70200-730
      • Local Institution - 0095
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30130-090
      • Local Institution - 0096
  • Parana
    • Curitiba, Parana, Brazil, 81520-060
      • Local Institution - 0221
  • RIO Grande DO SUL
    • Ijui, RIO Grande DO SUL, Brazil, 98700-000
      • Local Institution - 0059
    • Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
      • Local Institution - 0060
  • Santa Catarina
    • Itacorubi, Florianopolis, Santa Catarina, Brazil, 88034
      • Local Institution - 0223
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14780-070
      • Local Institution - 0061
    • Sao Jose De Rio Preto, Sao Paulo, Brazil, 15091-000
      • Local Institution - 0222
• Canada
  • Quebec, Canada, G1R 2J6
    • Local Institution - 0109
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution - 0129
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Local Institution - 0093
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Local Institution - 0092
  • Ontario
    • London, Ontario, Canada, N6A 4L6
      • Local Institution - 0094
    • Ottawa, Ontario, Canada, K1H 8L6
      • Local Institution - 0091
    • Toronto, Ontario, Canada, M5G 2M9
      • Local Institution - 0110
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Local Institution - 0134
    • Trois-Rivieres, Quebec, Canada, G8Z 3R9
      • Local Institution - 0214
• China
  • Shanghai, China, 200032
    • Local Institution - 0232
  • Tianjin, China, 300060
    • Local Institution - 0228
  • Beijing
    • Beijing, Beijing, China, 100142
      • Local Institution - 0240
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Local Institution - 0234
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Local Institution - 0227
    • Shanghai, Shanghai, China, 200032
      • Local Institution - 0239
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Local Institution - 0230
    • Hangzhou, Zhejiang, China, 310022
      • Local Institution - 0238
    • Linhai, Zhejiang, China, 317000
      • Local Institution - 0233
• Czechia
  • Brno, Czechia, 656 53
    • Local Institution - 0031
  • Hradec Kralove, Czechia, 500 05
    • Local Institution - 0029
  • Olomouc, Czechia, 779 00
    • Local Institution - 0030
• Denmark
  • Aarhus N, Denmark, 8200
    • Local Institution - 0166
• France
  • Avignon Cedes 9, France, 84918
    • Local Institution - 0215
  • Dijon Cedex, France, 21079
    • Local Institution - 0121
  • Lille, France, 59037
    • Local Institution - 0117
  • Paris, France, 75012
    • Local Institution - 0119
  • Pessac, France, 33604
    • Local Institution - 0120
  • Pierre Benite Cedex, France, 69495
    • Local Institution - 0118
  • Rennes Cedex 9, France, 35033
    • Local Institution - 0132
  • Rouen, France, 76000
    • Local Institution - 0149
  • Toulouse, France, 31403
    • Local Institution - 0148
• Germany
  • Berlin, Germany, 13353
    • Local Institution - 0006
  • Essen, Germany, 45136
    • Local Institution - 0008
  • Hamburg, Germany, 20251
    • Local Institution - 0007
  • Koeln, Germany, 50937
    • Local Institution - 0003
  • Marburg, Germany, 35043
    • Local Institution - 0017
  • Munich, Germany, 81675
    • Local Institution - 0005
  • Tuebingen, Germany, 72076
    • Local Institution - 0011
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Local Institution - 0001
• Hong Kong
  • Hong Kong, Hong Kong
    • Local Institution - 0225
• Hungary
  • Budapest, Hungary, 1097
    • Local Institution - 0053
  • Budapest, Hungary, 1122
    • Local Institution - 0224
  • Debrecen, Hungary
    • Local Institution - 0052
  • Kaposvar, Hungary, 7400
    • Local Institution - 0057
• Ireland
  • Dublin, Ireland, 9
    • Local Institution - 0040
  • Galway, Ireland
    • Local Institution - 0038
  • Cork
    • Wilton, Cork, Ireland
      • Local Institution - 0039
• Israel
  • Haifa, Israel, 31096
    • Local Institution - 0146
  • Jerusalem, Israel, 91120
    • Local Institution - 0144
  • Petach Tikva, Israel, 49100
    • Local Institution - 0143
  • Ramat-gan, Israel, 52621
    • Local Institution - 0145
  • Tel Aviv, Israel, 64239
    • Local Institution - 0142
• Italy
  • Bergamo, Italy, 24127
    • Local Institution - 0105
  • Milano, Italy, 20097
    • Local Institution - 0137
  • Milano, Italy, 20133
    • Local Institution - 0104
  • Reggio Emilia, Italy, 42100
    • Local Institution - 0106
  • Roma, Italy, 00168
    • Local Institution - 0107
• Japan
  • Fukuoka, Japan, 8111395
    • Local Institution - 0194
  • Kita-gun, Japan, 7610793
    • Local Institution - 0181
  • Akita
    • Akita-Shi, Akita, Japan, 0108543
      • Local Institution - 0173
  • Chiba
    • Chiba-shi, Chiba, Japan, 2608677
      • Local Institution - 0180
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 8128582
      • Local Institution - 0187
  • Gifu
    • Gifu-shi, Gifu, Japan, 5011194
      • Local Institution - 0189
  • Hiroshima
    • Hiroshima-Shi, Hiroshima, Japan, 7348551
      • Local Institution - 0183
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 0030027
      • Local Institution - 0192
    • Sapporo-shi, Hokkaido, Japan, 0608648
      • Local Institution - 0196
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 8908520
      • Local Institution - 0191
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan, 8608556
      • Local Institution - 0184
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 9808574
      • Local Institution - 0188
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
      • Local Institution - 0182
    • Suita-shi, Osaka, Japan, 565-0871
      • Local Institution - 0185
  • Saitama
    • Kitaadachi-gun, Saitama, Japan, 3620806
      • Local Institution - 0186
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 1040045
      • Local Institution - 0172
    • Koto-ku, Tokyo, Japan, 1358550
      • Local Institution - 0190
    • Minato-ku, Tokyo, Japan, 1058470
      • Local Institution - 0174
    • Shinjuku-ku, Tokyo, Japan, 1600023
      • Local Institution - 0193
    • Shinjuuku-ku, Tokyo, Japan, 1608582
      • Local Institution - 0204
• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Local Institution - 0176
  • Seoul, Korea, Republic of, 05505
    • Local Institution - 0175
• Mexico
  • Aguascalientes, Mexico, 20230
    • Local Institution - 0154
  • Ciudad de Mexico, Mexico, 06760
    • Local Institution - 0168
  • Distrito Federal, Mexico, 14080
    • Local Institution - 0084
  • Chiapas
    • Tuxtla Gutierrez, Chiapas, Mexico, 29038
      • Local Institution - 0212
  • Distrito Federal C.p.
    • Tlalpan, Distrito Federal C.p., Mexico, 14000
      • Local Institution - 0085
  • Guanajuato
    • Leon, Guanajato, Guanajuato, Mexico, 37000
      • Local Institution - 0127
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Local Institution - 0089
  • Groningen, Netherlands, 9713 AP
    • Local Institution - 0042
  • Maastrict, Netherlands, 6229 HX
    • Local Institution - 0043
• Peru
  • Callao, Peru, 02
    • Local Institution - 0195
  • Lima, Peru, 34
    • Local Institution - 0162
  • Lima, Peru, LIMA 31
    • Local Institution - 0141
  • Lima, Peru, LIMA 41
    • Local Institution - 0088
• Poland
  • Gliwice, Poland, 44-101
    • Local Institution - 0083
  • Krakow, Poland, 31-202
    • Local Institution - 0138
  • Lublin, Poland, 20-081
    • Local Institution - 0139
  • Warszawa, Poland, 02-781
    • Local Institution - 0081
  • Wielkopolskie
    • Poznan, Wielkopolskie, Poland, 60-780
      • Local Institution - 0082
• Puerto Rico
  • San Juan, Puerto Rico, 00927
    • Local Institution - 0097
• Romania
  • Baia Mare, Romania, 430295
    • Local Institution - 0167
  • Bucharest, Romania, 022328
    • Local Institution - 0163
  • Bucuresti, Romania, 021389
    • Local Institution - 0197
  • Cluj-napoca, Romania, 400352
    • Local Institution - 0103
  • Craiova, Romania, 200347
    • Local Institution - 0028
  • Floresti, Romania, 407280
    • Local Institution - 0135
• Russian Federation
  • Cheboksary, Russian Federation, 428020
    • Local Institution - 0213
  • Moscow, Russian Federation, 115478
    • Local Institution - 0125
  • Saint-Petersburg, Russian Federation, 197022
    • Local Institution - 0209
  • St. Petersburg, Russian Federation, 197758
    • Local Institution - 0136
• Singapore
  • Singapore, Singapore, 119228
    • Local Institution - 0218
  • Singapore, Singapore, 169610
    • Local Institution - 0219
• Spain
  • Barcelona, Spain, 08035
    • Local Institution - 0078
  • Cordoba, Spain, 14004
    • Local Institution - 0079
  • Madrid, Spain, 28007
    • Local Institution - 0080
  • Madrid, Spain, 28050
    • Local Institution - 0077
• Switzerland
  • Basel, Switzerland, 4031
    • Local Institution - 0018
  • St Gallen, Switzerland, 9007
    • Local Institution - 0047
• Taiwan
  • Taichung, Taiwan, 40447
    • Local Institution - 0177
  • Tainan, Taiwan, 70403
    • Local Institution - 0178
  • Taipei, Taiwan, 100
    • Local Institution - 0179
• Turkey
  • Adana, Turkey, 01250
    • Local Institution - 0160
  • Erzurum, Turkey, 25240
    • Local Institution - 0161
  • Istanbul, Turkey, 34300
    • Local Institution - 0157
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Local Institution - 0243
  • London, United Kingdom, SE1 9RT
    • Local Institution - 0202
  • Greater London
    • London, Greater London, United Kingdom, SW3 6JJ
      • Local Institution - 0045
    • London, Greater London, United Kingdom, NW1 2PG
      • Local Institution - 0203
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Local Institution - 0046
  • Manchester
    • Withington, Manchester, United Kingdom, M20 4BX
      • Local Institution - 0049
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Local Institution - 0169
• United States
  • Arizona
    • Tucson, Arizona, United States, 85711
      • Local Institution - 0250
  • California
    • Los Angeles, California, United States, 90033
      • Local Institution - 0026
    • San Francisco, California, United States, 94115
      • Pacific Hematology Oncology Associates
    • San Francisco, California, United States, 94158
      • Local Institution - 0068
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Local Institution - 0151
    • Denver, Colorado, United States, 80218
      • Local Institution - 0247
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Local Institution - 0054
  • Florida
    • Fort Myers, Florida, United States, 33901
      • Local Institution - 0113
    • Jacksonville, Florida, United States, 32256
      • Local Institution - 0131
    • Miami, Florida, United States, 33136
      • Local Institution - 0226
    • Pensacola, Florida, United States, 32504
      • Local Institution - 0022
    • Saint Petersburg, Florida, United States, 33705
      • Local Institution - 0114
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Local Institution - 0153
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Local Institution - 0025
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0170
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0171
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0055
    • Boston, Massachusetts, United States, 02215
      • Local Institution - 0217
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Local Institution - 0027
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Local Institution - 0058
    • Neptune, New Jersey, United States, 07753
      • Local Institution - 0066
  • New York
    • Bronx, New York, United States, 10461
      • Local Institution - 0205
    • New York, New York, United States, 10016
      • Local Institution - 0032
  • North Carolina
    • Charlotte, North Carolina, United States, 28262
      • Local Institution - 0033
    • Durham, North Carolina, United States, 27710
      • Local Institution - 0024
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Local Institution - 0056
  • Oregon
    • Portland, Oregon, United States, 97239
      • Local Institution - 0165
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Local Institution - 0101
    • Philadelphia, Pennsylvania, United States, 19111
      • Local Institution - 0048
    • Pittsburgh, Pennsylvania, United States, 15224
      • Local Institution - 0116
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Local Institution - 0111
    • Nashville, Tennessee, United States, 37232
      • Local Institution - 0130
  • Texas
    • Dallas, Texas, United States, 75216
      • Local Institution - 0216
    • Dallas, Texas, United States, 75246
      • Local Institution - 0248
    • Houston, Texas, United States, 77030-4009
      • Local Institution - 0012
  • Washington
    • Seattle, Washington, United States, 98101
      • Local Institution - 0241
    • Seattle, Washington, United States, 98109
      • Local Institution - 0067
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Local Institution - 0069

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Participants who have received a live/attenuated vaccine within 30 days of the first treatment

Other protocol defined Inclusion/exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Specified dose on specified days
Experimental: Nivolumab	Drug: Nivolumab; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free Survival (DFS)	Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first. Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment	From randomization to the date of recurrence or death (up to approximately 46 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Overall survival is defined as the time from randomization to the date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date"). Overall survival was censored at the date of randomization for subjects who were randomized but had no follow-up.	From randomization to the date of death (up to approximately 46 months)
Overall Survival Rate	Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization	From randomization to 1, 2 and 3 years later

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharmaceutical Co. Ltd
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

General Publications

• Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125. Erratum In: N Engl J Med. 2023 Feb 16;388(7):672.

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2016
• Primary Completion (Actual): May 12, 2020
• Study Completion (Estimated): October 11, 2025

Study Registration Dates

• First Submitted: April 15, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (Estimated): April 19, 2016

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA209-577; 2015-005556-10 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No