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

NCT02743494 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: CA209-5772015-005556-10
• Study Type: interventional
• Target: 794
• Locations: 31 countries
• Sites: 204

Brief Summary

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

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Overall Survival (OS)

  From randomization to the date of death (up to approximately 60 months)

• Overall Survival Rates at 12-, 24-, and 36-months

  At 12-, 24- and 36-months post first dose.

Study Arms (2)

Nivolumab

EXPERIMENTAL

Drug: Nivolumab

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Nivolumab DRUG

Specified dose on specified days

Nivolumab

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (204)

Local Institution - 0250

Tucson, Arizona, 85711, United States

Location

Local Institution - 0026

Los Angeles, California, 90033, United States

Location

Local Institution - 0023

San Francisco, California, 94115, United States

Location

Local Institution - 0068

San Francisco, California, 94158, United States

Location

Local Institution - 0151

Aurora, Colorado, 80045, United States

Location

Local Institution - 0247

Denver, Colorado, 80218, United States

Location

Local Institution - 0054

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 0113

Fort Myers, Florida, 33901, United States

Location

Local Institution - 0131

Jacksonville, Florida, 32256, United States

Location

Local Institution - 0226

Miami, Florida, 33136, United States

Location

Local Institution - 0022

Pensacola, Florida, 32504, United States

Location

Local Institution - 0114

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 0153

Chicago, Illinois, 60637, United States

Location

Local Institution - 0025

Baltimore, Maryland, 21202, United States

Location

Local Institution - 0055

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0170

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0171

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0217

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0027

St Louis, Missouri, 63110, United States

Location

Local Institution - 0058

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0066

Neptune City, New Jersey, 07753, United States

Location

Local Institution - 0032

New York, New York, 10016, United States

Location

Local Institution - 0205

The Bronx, New York, 10461, United States

Location

Local Institution - 0033

Charlotte, North Carolina, 28262, United States

Location

Local Institution - 0024

Durham, North Carolina, 27710, United States

Location

Local Institution - 0056

Cleveland, Ohio, 44106, United States

Location

Local Institution - 0165

Portland, Oregon, 97239, United States

Location

Local Institution - 0101

Allentown, Pennsylvania, 18103, United States

Location

Local Institution - 0048

Philadelphia, Pennsylvania, 19111, United States

Location

Local Institution - 0116

Pittsburgh, Pennsylvania, 15212, United States

Location

Local Institution - 0111

Nashville, Tennessee, 37203, United States

Location

Local Institution - 0130

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0216

Dallas, Texas, 75216, United States

Location

Local Institution - 0248

Dallas, Texas, 75246, United States

Location

Local Institution - 0012

Houston, Texas, 77030-4009, United States

Location

Local Institution - 0241

Seattle, Washington, 98101, United States

Location

Local Institution - 0067

Seattle, Washington, 98109, United States

Location

Local Institution - 0069

Madison, Wisconsin, 53792, United States

Location

Local Institution - 0050

Capital Federal, Buenos Aires, 1264, Argentina

Location

Local Institution - 0152

Capital Federal, Buenos Aires, 1280, Argentina

Location

Local Institution - 0164

Ciudad Autonoma Buenos Aires, Distrito Federal, 1118, Argentina

Location

Local Institution - 0207

Viedma, Río Negro Province, 8500, Argentina

Location

Local Institution - 0208

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution - 0051

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution - 0198

Buenos Aires, 1093 AAS, Argentina

Location

Local Institution - 0133

CABA, 1426, Argentina

Location

Local Institution - 0112

Córdoba, X5006HBF, Argentina

Location

Local Institution - 0200

Blacktown, New South Wales, 2148, Australia

Location

Local Institution - 0098

Gosford, New South Wales, 2250, Australia

Location

Local Institution - 0140

Kanwal, New South Wales, 2263, Australia

Location

Local Institution - 0074

St Leonards, New South Wales, 2065, Australia

Location

Local Institution - 0075

Tamworth, New South Wales, 2340, Australia

Location

Local Institution - 0237

Brisbane, Queensland, 4102, Australia

Location

Local Institution - 0123

Adelaide, South Australia, 5000, Australia

Location

Local Institution - 0072

Clayton, Victoria, 3168, Australia

Location

Local Institution - 0156

Perth, Western Australia, 6150, Australia

Location

Local Institution - 0099

Hobart, 7000, Australia

Location

Local Institution - 0035

Brussels, 1200, Belgium

Location

Local Institution - 0037

Edegem, 2650, Belgium

Location

Local Institution - 0086

Ghent, 9000, Belgium

Location

Local Institution - 0034

Leuven, 3000, Belgium

Location

Local Institution - 0036

Liège, 4000, Belgium

Location

Local Institution - 0087

Namur, 5000, Belgium

Location

Local Institution - 0095

Brasília, Federal District, 70200-730, Brazil

Location

Local Institution - 0096

Belo Horizonte, Minas Gerais, 30130-090, Brazil

Location

Local Institution - 0221

Curitiba, Paraná, 81520-060, Brazil

Location

Local Institution - 0059

Ijuí, Rio Grande do Sul, 98700-000, Brazil

Location

Local Institution - 0060

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Local Institution - 0223

Itacorubi, Florianopolis, Santa Catarina, 88034, Brazil

Location

Local Institution - 0061

Barretos, São Paulo, 14780-070, Brazil

Location

Local Institution - 0222

Sao Jose de Rio Preto, São Paulo, 15091-000, Brazil

Location

Local Institution - 0065

Rio de Janeiro, 22793-080, Brazil

Location

Local Institution - 0064

Salvador, 0, Brazil

Location

Local Institution - 0062

São Paulo, 01246-000, Brazil

Location

Local Institution - 0063

São Paulo, 01308-050, Brazil

Location

Local Institution - 0129

Edmonton, Alberta, T6G 1Z2, Canada

Location

Local Institution - 0093

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Local Institution - 0092

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Local Institution - 0094

London, Ontario, N6A 4L6, Canada

Location

Local Institution - 0091

Ottawa, Ontario, K1H 8L6, Canada

Location

Local Institution - 0110

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0134

Montreal, Quebec, H4A 3J1, Canada

Location

Local Institution - 0109

Québec, Quebec, G1R 2J6, Canada

Location

Local Institution - 0214

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

Local Institution - 0240

Beijing, Beijing Municipality, 100142, China

Location

Local Institution - 0234

Fuzhou, Fujian, 350014, China

Location

Local Institution - 0227

Shanghai, Shanghai Municipality, 200030, China

Location

Local Institution - 0239

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution - 0230

Hangzhou, Zhejiang, 310003, China

Location

Local Institution - 0238

Hangzhou, Zhejiang, 310022, China

Location

Local Institution - 0233

Linhai, Zhejiang, 317000, China

Location

Local Institution - 0232

Shanghai, 200032, China

Location

Local Institution - 0228

Tianjin, 300060, China

Location

Local Institution - 0031

Brno, 656 53, Czechia

Location

Local Institution - 0029

Hradec Králové, 500 05, Czechia

Location

Local Institution - 0030

Olomouc, 779 00, Czechia

Location

Local Institution - 0166

Aarhus N, Central Jutland, 8200, Denmark

Location

Local Institution - 0215

Avignon Cedes 9, 84918, France

Location

Local Institution - 0121

Dijon, 21079, France

Location

Local Institution - 0117

Lille, 59037, France

Location

Local Institution - 0119

Paris, 75012, France

Location

Local Institution - 0120

Pessac, 33604, France

Location

Local Institution - 0118

Pierre-Bénite, 69495, France

Location

Local Institution - 0132

Rennes, 35033, France

Location

Local Institution - 0149

Rouen, 76000, France

Location

Local Institution - 0148

Toulouse, 31403, France

Location

Local Institution - 0001

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Local Institution - 0006

Berlin, D-13353, Germany

Location

Local Institution - 0003

Cologne, 50937, Germany

Location

Local Institution - 0008

Essen, 45136, Germany

Location

Local Institution - 0007

Hamburg, 20251, Germany

Location

Local Institution - 0017

Marburg, 35043, Germany

Location

Local Institution - 0005

Munich, 81675, Germany

Location

Local Institution - 0011

Tübingen, 72076, Germany

Location

Local Institution - 0225

Hong Kong, 0, Hong Kong

Location

Local Institution - 0053

Budapest, 1097, Hungary

Location

Local Institution - 0224

Budapest, 1122, Hungary

Location

Local Institution - 0052

Debrecen, 0, Hungary

Location

Local Institution - 0057

Kaposvár, 7400, Hungary

Location

Local Institution - 0039

Wilton, CORK, 0, Ireland

Location

Local Institution - 0040

Dublin, 9, Ireland

Location

Local Institution - 0038

Galway, Ireland

Location

Local Institution - 0146

Haifa, 31096, Israel

Location

Local Institution - 0144

Jerusalem, 91120, Israel

Location

Local Institution - 0143

Petah Tikva, 49100, Israel

Location

Local Institution - 0145

Ramat Gan, 52621, Israel

Location

Local Institution - 0142

Tel Aviv, 64239, Israel

Location

Local Institution - 0105

Bergamo, 24127, Italy

Location

Local Institution - 0137

Milan, 20097, Italy

Location

Local Institution - 0104

Milan, 20133, Italy

Location

Local Institution - 0106

Reggio Emilia, 42100, Italy

Location

Local Institution - 0107

Roma, 00168, Italy

Location

Local Institution - 0173

Akita, Akita, 0108543, Japan

Location

Local Institution - 0180

Chiba, Chiba, 2608677, Japan

Location

Local Institution - 0187

Fukuoka, Fukuoka, 8128582, Japan

Location

Local Institution - 0189

Gifu, Gifu, 5011194, Japan

Location

Local Institution - 0183

Hiroshima, Hiroshima, 7348551, Japan

Location

Local Institution - 0192

Sapporo, Hokkaido, 0030027, Japan

Location

Local Institution - 0196

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution - 0191

Kagoshima, Kagoshima-ken, 8908520, Japan

Location

Local Institution - 0184

Kumamoto, Kumamoto, 8608556, Japan

Location

Local Institution - 0188

Sendai, Miyagi, 9808574, Japan

Location

Local Institution - 0182

Sayama, Osaka, 589-8511, Japan

Location

Local Institution - 0185

Suita-shi, Osaka, 565-0871, Japan

Location

Local Institution - 0186

Kitaadachi-gun, Saitama, 3620806, Japan

Location

Local Institution - 0172

Chuo-ku, Tokyo, 1040045, Japan

Location

Local Institution - 0190

Koto-ku, Tokyo, 1358550, Japan

Location

Local Institution - 0174

Minato-ku, Tokyo, 1058470, Japan

Location

Local Institution - 0193

Shinjuku-ku, Tokyo, 1600023, Japan

Location

Local Institution - 0204

Shinjuuku-ku, Tokyo, 1608582, Japan

Location

Local Institution - 0194

Fukuoka, 8111395, Japan

Location

Local Institution - 0181

Kita-gun, 7610793, Japan

Location

Local Institution - 0212

Tuxtla Gutiérrez, Chiapas, 29038, Mexico

Location

Local Institution - 0085

Tlalpan, Distrito Federal C.p., 14000, Mexico

Location

Local Institution - 0127

Leon, Guanajato, Guanajuato, 37000, Mexico

Location

Local Institution - 0154

Aguascalientes, 20230, Mexico

Location

Local Institution - 0084

Distrito Federal, 14080, Mexico

Location

Local Institution - 0168

Mexico City, 06760, Mexico

Location

Local Institution - 0089

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Local Institution - 0042

Groningen, 9713 AP, Netherlands

Location

Local Institution - 0043

Maastrict, 6229 HX, Netherlands

Location

Local Institution - 0195

Callao, 02, Peru

Location

Local Institution - 0162

Lima, 34, Peru

Location

Local Institution - 0141

Lima, LIMA 31, Peru

Location

Local Institution - 0088

Lima, LIMA 41, Peru

Location

Local Institution - 0083

Gliwice, 44-101, Poland

Location

Local Institution - 0138

Krakow, 31-202, Poland

Location

Local Institution - 0139

Lublin, 20-081, Poland

Location

Local Institution - 0082

Poznan, 60-780, Poland

Location

Local Institution - 0081

Warsaw, 02-781, Poland

Location

Local Institution - 0097

San Juan, 00927, Puerto Rico

Location

Local Institution - 0167

Baia Mare, 430295, Romania

Location

Local Institution - 0197

Bucharest, 021389, Romania

Location

Local Institution - 0163

Bucharest, 022328, Romania

Location

Local Institution - 0103

Cluj-Napoca, 400352, Romania

Location

Local Institution - 0028

Craiova, 200347, Romania

Location

Local Institution - 0135

Floreşti, 407280, Romania

Location

Local Institution - 0213

Cheboksary, 428020, Russia

Location

Local Institution - 0125

Moscow, 115478, Russia

Location

Local Institution - 0209

Saint Petersburg, 197022, Russia

Location

Local Institution - 0136

Saint Petersburg, 197758, Russia

Location

Local Institution - 0219

Singapore, Central Singapore, 168583, Singapore

Location

Local Institution - 0218

Singapore, 119228, Singapore

Location

Local Institution - 0175

Songpa-gu, Seoul, 05505, South Korea

Location

Local Institution - 0176

Seoul, 120-752, South Korea

Location

Local Institution - 0078

Barcelona, 08035, Spain

Location

Local Institution - 0079

Córdoba, 14004, Spain

Location

Local Institution - 0080

Madrid, 28007, Spain

Location

Local Institution - 0077

Madrid, 28050, Spain

Location

Local Institution - 0018

Basel, 4031, Switzerland

Location

Local Institution - 0047

Sankt Gallen, 9007, Switzerland

Location

Local Institution - 0177

Taichung, 40447, Taiwan

Location

Local Institution - 0178

Tainan, 70403, Taiwan

Location

Local Institution - 0179

Taipei, 100, Taiwan

Location

Local Institution - 0160

Adana, 01250, Turkey (Türkiye)

Location

Local Institution - 0161

Erzurum, 25240, Turkey (Türkiye)

Location

Local Institution - 0157

Istanbul, 34300, Turkey (Türkiye)

Location

Local Institution - 0203

London, Greater London, NW1 2PG, United Kingdom

Location

Local Institution - 0045

London, Greater London, SW3 6JJ, United Kingdom

Location

Local Institution - 0046

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Local Institution - 0049

Withington, Manchester, M20 4BX, United Kingdom

Location

Local Institution - 0169

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Local Institution - 0243

Cardiff, CF14 2TL, United Kingdom

Location

Local Institution - 0202

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

• 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. doi: 10.1056/NEJMx220014.

  PMID: 33789008 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 19, 2016
• Study Start: July 14, 2016
• Primary Completion: May 12, 2020
• Study Completion: November 7, 2024
• Last Updated: November 18, 2025
• Results First Posted: June 22, 2021

Record last verified: 2025-11

Locations

HU (4); PE (4); ME (6); PL (5); SG (2); JP (20); IE (3); PR (1); IT (5); CZ (3); HK (1); IL (5); TW (3); GB (7); AU (10); DK (1); RO (6); TU (3); KR (2); CH (2); BR (12); US (38); NL (3); RU (4); FR (9); DE (8); AR (9); ES (4); CA (9); CN (9); BE (6)