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Advanced CancerPhase 3CheckMate 577NCT02743494

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

A Phase 3 study testing Nivolumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 204 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Cancer
What is being tested?
Nivolumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
794 participants
Where
204 sitesin 31 countries
Study dates
14 Jul 2016to 7 Nov 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

204 sites in 31 countries.

204 sites in 31 countries

United States38 sites

  • Local Institution - 0101

    Allentown, Pennsylvania, 18103

  • Local Institution - 0151

    Aurora, Colorado, 80045

  • Local Institution - 0025

    Baltimore, Maryland, 21202

  • Local Institution - 0055

    Boston, Massachusetts, 02215

  • Local Institution - 0170

    Boston, Massachusetts, 02215

  • Local Institution - 0171

    Boston, Massachusetts, 02215

  • Local Institution - 0217

    Boston, Massachusetts, 02215

  • Local Institution - 0033

    Charlotte, North Carolina, 28262

  • Local Institution - 0153

    Chicago, Illinois, 60637

  • Local Institution - 0056

    Cleveland, Ohio, 44106

  • Local Institution - 0216

    Dallas, Texas, 75216

  • Local Institution - 0248

    Dallas, Texas, 75246

  • Local Institution - 0247

    Denver, Colorado, 80218

  • Local Institution - 0024

    Durham, North Carolina, 27710

  • Local Institution - 0113

    Fort Myers, Florida, 33901

  • Local Institution - 0058

    Hackensack, New Jersey, 07601

  • Local Institution - 0012

    Houston, Texas, 77030-4009

  • Local Institution - 0131

    Jacksonville, Florida, 32256

  • Local Institution - 0026

    Los Angeles, California, 90033

  • Local Institution - 0069

    Madison, Wisconsin, 53792

  • Local Institution - 0226

    Miami, Florida, 33136

  • Local Institution - 0111

    Nashville, Tennessee, 37203

  • Local Institution - 0130

    Nashville, Tennessee, 37232

  • Local Institution - 0066

    Neptune City, New Jersey, 07753

  • Local Institution - 0032

    New York, New York, 10016

  • Local Institution - 0022

    Pensacola, Florida, 32504

  • Local Institution - 0048

    Philadelphia, Pennsylvania, 19111

  • Local Institution - 0116

    Pittsburgh, Pennsylvania, 15212

  • Local Institution - 0165

    Portland, Oregon, 97239

  • Local Institution - 0023

    San Francisco, California, 94115

  • Local Institution - 0068

    San Francisco, California, 94158

  • Local Institution - 0241

    Seattle, Washington, 98101

  • Local Institution - 0067

    Seattle, Washington, 98109

  • Local Institution - 0027

    St Louis, Missouri, 63110

  • Local Institution - 0114

    St. Petersburg, Florida, 33705

  • Local Institution - 0205

    The Bronx, New York, 10461

  • Local Institution - 0250

    Tucson, Arizona, 85711

  • Local Institution - 0054

    Washington D.C., District of Columbia, 20007

Other trials in United States

Japan20 sites

  • Local Institution - 0173

    Akita, Akita, 0108543

  • Local Institution - 0180

    Chiba, Chiba, 2608677

  • Local Institution - 0172

    Chuo-ku, Tokyo, 1040045

  • Local Institution - 0187

    Fukuoka, Fukuoka, 8128582

  • Local Institution - 0194

    Fukuoka, 8111395

  • Local Institution - 0189

    Gifu, Gifu, 5011194

  • Local Institution - 0183

    Hiroshima, Hiroshima, 7348551

  • Local Institution - 0191

    Kagoshima, Kagoshima-ken, 8908520

  • Local Institution - 0181

    Kita-gun, 7610793

  • Local Institution - 0186

    Kitaadachi-gun, Saitama, 3620806

  • Local Institution - 0190

    Koto-ku, Tokyo, 1358550

  • Local Institution - 0184

    Kumamoto, Kumamoto, 8608556

  • Local Institution - 0174

    Minato-ku, Tokyo, 1058470

  • Local Institution - 0192

    Sapporo, Hokkaido, 0030027

  • Local Institution - 0196

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0182

    Sayama, Osaka, 589-8511

  • Local Institution - 0188

    Sendai, Miyagi, 9808574

  • Local Institution - 0193

    Shinjuku-ku, Tokyo, 1600023

  • Local Institution - 0204

    Shinjuuku-ku, Tokyo, 1608582

  • Local Institution - 0185

    Suita-shi, Osaka, 565-0871

Other trials in Japan

Brazil12 sites

  • Local Institution - 0061

    Barretos, São Paulo, 14780-070

  • Local Institution - 0096

    Belo Horizonte, Minas Gerais, 30130-090

  • Local Institution - 0095

    Brasília, Federal District, 70200-730

  • Local Institution - 0221

    Curitiba, Paraná, 81520-060

  • Local Institution - 0059

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0223

    Itacorubi, Florianopolis, Santa Catarina, 88034

  • Local Institution - 0060

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Local Institution - 0065

    Rio de Janeiro, 22793-080

  • Local Institution - 0064

    Salvador, 0

  • Local Institution - 0222

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

  • Local Institution - 0062

    São Paulo, 01246-000

  • Local Institution - 0063

    São Paulo, 01308-050

Other trials in Brazil

Australia10 sites

  • Local Institution - 0123

    Adelaide, South Australia, 5000

  • Local Institution - 0200

    Blacktown, New South Wales, 2148

  • Local Institution - 0237

    Brisbane, Queensland, 4102

  • Local Institution - 0072

    Clayton, Victoria, 3168

  • Local Institution - 0098

    Gosford, New South Wales, 2250

  • Local Institution - 0099

    Hobart, 7000

  • Local Institution - 0140

    Kanwal, New South Wales, 2263

  • Local Institution - 0156

    Perth, Western Australia, 6150

  • Local Institution - 0074

    St Leonards, New South Wales, 2065

  • Local Institution - 0075

    Tamworth, New South Wales, 2340

Other trials in Australia

Argentina9 sites

  • Local Institution - 0198

    Buenos Aires, 1093 AAS

  • Local Institution - 0133

    CABA, 1426

  • Local Institution - 0050

    Capital Federal, Buenos Aires, 1264

  • Local Institution - 0152

    Capital Federal, Buenos Aires, 1280

  • Local Institution - 0164

    Ciudad Autonoma Buenos Aires, Distrito Federal, 1118

  • Local Institution - 0112

    Córdoba, X5006HBF

  • Local Institution - 0208

    Rosario, Santa Fe Province, 2000

  • Local Institution - 0051

    San Miguel de Tucumán, Tucumán Province, 4000

  • Local Institution - 0207

    Viedma, Río Negro Province, 8500

Other trials in Argentina

Canada9 sites

  • Local Institution - 0129

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0092

    Halifax, Nova Scotia, B3H 1V7

  • Local Institution - 0094

    London, Ontario, N6A 4L6

  • Local Institution - 0134

    Montreal, Quebec, H4A 3J1

  • Local Institution - 0091

    Ottawa, Ontario, K1H 8L6

  • Local Institution - 0109

    Québec, Quebec, G1R 2J6

  • Local Institution - 0110

    Toronto, Ontario, M5G 2M9

  • Local Institution - 0214

    Trois-Rivières, Quebec, G8Z 3R9

  • Local Institution - 0093

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

China9 sites

  • Local Institution - 0240

    Beijing, Beijing Municipality, 100142

  • Local Institution - 0234

    Fuzhou, Fujian, 350014

  • Local Institution - 0230

    Hangzhou, Zhejiang, 310003

  • Local Institution - 0238

    Hangzhou, Zhejiang, 310022

  • Local Institution - 0233

    Linhai, Zhejiang, 317000

  • Local Institution - 0227

    Shanghai, Shanghai Municipality, 200030

  • Local Institution - 0239

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0232

    Shanghai, 200032

  • Local Institution - 0228

    Tianjin, 300060

Other trials in China

France9 sites

  • Local Institution - 0215

    Avignon Cedes 9, 84918

  • Local Institution - 0121

    Dijon, 21079

  • Local Institution - 0117

    Lille, 59037

  • Local Institution - 0119

    Paris, 75012

  • Local Institution - 0120

    Pessac, 33604

  • Local Institution - 0118

    Pierre-Bénite, 69495

  • Local Institution - 0132

    Rennes, 35033

  • Local Institution - 0149

    Rouen, 76000

  • Local Institution - 0148

    Toulouse, 31403

Other trials in France

Germany8 sites

  • Local Institution - 0006

    Berlin, D-13353

  • Local Institution - 0003

    Cologne, 50937

  • Local Institution - 0008

    Essen, 45136

  • Local Institution - 0007

    Hamburg, 20251

  • Local Institution - 0001

    Mainz, Rhineland-Palatinate, 55131

  • Local Institution - 0017

    Marburg, 35043

  • Local Institution - 0005

    Munich, 81675

  • Local Institution - 0011

    Tübingen, 72076

Other trials in Germany

United Kingdom7 sites

  • Local Institution - 0243

    Cardiff, CF14 2TL

  • Local Institution - 0203

    London, Greater London, NW1 2PG

  • Local Institution - 0045

    London, Greater London, SW3 6JJ

  • Local Institution - 0202

    London, SE1 9RT

  • Local Institution - 0046

    Southampton, Hampshire, SO16 6YD

  • Local Institution - 0169

    Sutton, Surrey, SM2 5PT

  • Local Institution - 0049

    Withington, Manchester, M20 4BX

Other trials in United Kingdom

Belgium6 sites

  • Local Institution - 0035

    Brussels, 1200

  • Local Institution - 0037

    Edegem, 2650

  • Local Institution - 0086

    Ghent, 9000

  • Local Institution - 0034

    Leuven, 3000

  • Local Institution - 0036

    Liège, 4000

  • Local Institution - 0087

    Namur, 5000

Other trials in Belgium

Mexico6 sites

  • Local Institution - 0154

    Aguascalientes, 20230

  • Local Institution - 0084

    Distrito Federal, 14080

  • Local Institution - 0127

    Leon, Guanajato, Guanajuato, 37000

  • Local Institution - 0168

    Mexico City, 06760

  • Local Institution - 0085

    Tlalpan, Distrito Federal C.p., 14000

  • Local Institution - 0212

    Tuxtla Gutiérrez, Chiapas, 29038

Other trials in Mexico

Romania6 sites

  • Local Institution - 0167

    Baia Mare, 430295

  • Local Institution - 0197

    Bucharest, 021389

  • Local Institution - 0163

    Bucharest, 022328

  • Local Institution - 0103

    Cluj-Napoca, 400352

  • Local Institution - 0028

    Craiova, 200347

  • Local Institution - 0135

    Floreşti, 407280

Other trials in Romania

Israel5 sites

  • Local Institution - 0146

    Haifa, 31096

  • Local Institution - 0144

    Jerusalem, 91120

  • Local Institution - 0143

    Petah Tikva, 49100

  • Local Institution - 0145

    Ramat Gan, 52621

  • Local Institution - 0142

    Tel Aviv, 64239

Other trials in Israel

Italy5 sites

  • Local Institution - 0105

    Bergamo, 24127

  • Local Institution - 0137

    Milan, 20097

  • Local Institution - 0104

    Milan, 20133

  • Local Institution - 0106

    Reggio Emilia, 42100

  • Local Institution - 0107

    Roma, 00168

Other trials in Italy

Poland5 sites

  • Local Institution - 0083

    Gliwice, 44-101

  • Local Institution - 0138

    Krakow, 31-202

  • Local Institution - 0139

    Lublin, 20-081

  • Local Institution - 0082

    Poznan, 60-780

  • Local Institution - 0081

    Warsaw, 02-781

Other trials in Poland

Hungary4 sites

  • Local Institution - 0053

    Budapest, 1097

  • Local Institution - 0224

    Budapest, 1122

  • Local Institution - 0052

    Debrecen, 0

  • Local Institution - 0057

    Kaposvár, 7400

Other trials in Hungary

Peru4 sites

  • Local Institution - 0195

    Callao, 02

  • Local Institution - 0162

    Lima, 34

  • Local Institution - 0141

    Lima, LIMA 31

  • Local Institution - 0088

    Lima, LIMA 41

Other trials in Peru

Russia4 sites

  • Local Institution - 0213

    Cheboksary, 428020

  • Local Institution - 0125

    Moscow, 115478

  • Local Institution - 0209

    Saint Petersburg, 197022

  • Local Institution - 0136

    Saint Petersburg, 197758

Other trials in Russia

Spain4 sites

  • Local Institution - 0078

    Barcelona, 08035

  • Local Institution - 0079

    Córdoba, 14004

  • Local Institution - 0080

    Madrid, 28007

  • Local Institution - 0077

    Madrid, 28050

Other trials in Spain

Czechia3 sites

  • Local Institution - 0031

    Brno, 656 53

  • Local Institution - 0029

    Hradec Králové, 500 05

  • Local Institution - 0030

    Olomouc, 779 00

Other trials in Czechia

Ireland3 sites

  • Local Institution - 0040

    Dublin, 9

  • Local Institution - 0038

    Galway

  • Local Institution - 0039

    Wilton, CORK, 0

Other trials in Ireland

Netherlands3 sites

  • Local Institution - 0089

    Amsterdam, North Holland, 1066 CX

  • Local Institution - 0042

    Groningen, 9713 AP

  • Local Institution - 0043

    Maastrict, 6229 HX

Other trials in Netherlands

Taiwan3 sites

  • Local Institution - 0177

    Taichung, 40447

  • Local Institution - 0178

    Tainan, 70403

  • Local Institution - 0179

    Taipei, 100

Other trials in Taiwan

Turkey (Türkiye)3 sites

  • Local Institution - 0160

    Adana, 01250

  • Local Institution - 0161

    Erzurum, 25240

  • Local Institution - 0157

    Istanbul, 34300

Other trials in Turkey (Türkiye)

Singapore2 sites

  • Local Institution - 0219

    Singapore, Central Singapore, 168583

  • Local Institution - 0218

    Singapore, 119228

Other trials in Singapore

South Korea2 sites

  • Local Institution - 0176

    Seoul, 120-752

  • Local Institution - 0175

    Songpa-gu, Seoul, 05505

Other trials in South Korea

Switzerland2 sites

  • Local Institution - 0018

    Basel, 4031

  • Local Institution - 0047

    Sankt Gallen, 9007

Other trials in Switzerland

Denmark1 site

  • Local Institution - 0166

    Aarhus N, Central Jutland, 8200

Other trials in Denmark

Hong Kong1 site

  • Local Institution - 0225

    Hong Kong, 0

Other trials in Hong Kong

Puerto Rico1 site

  • Local Institution - 0097

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Advanced Cancer
Being tested
Nivolumab, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Specified dose on specified days

  • PlaceboOther

    Specified dose on specified days

Study groups in NCT02743494
Study groupRoleWhat they receive
NivolumabExperimentalNot described
Receives: Drug: Nivolumab
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From randomization to the date of recurrence or death (up to approximately 46 months)

Secondary outcomes (2)

  1. 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.

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

  2. Overall Survival Rates at 12-, 24-, and 36-months

    Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following randomization

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2016 (estimated)
  2. Study start14 Jul 2016
  3. Primary completion12 May 2020
  4. Study completion7 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
794 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02743494
Sponsor's protocol ID
CA209-577
Other IDs
2015-005556-10, 2015
Acronym
CheckMate 577
Status last verified
Nov 2025
First submitted
15 Apr 2016
Last updated
18 Nov 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

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.

    PubMed 33789008

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab in people with Advanced Cancer, run by Bristol-Myers Squibb at 204 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 204 sites in United States, Japan, Brazil, Australia, Argentina and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (DFS) (time frame: From randomization to the date of recurrence or death (up to approximately 46 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02743494, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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