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Various Advanced CancerPhase 3CheckMate 274NCT02632409

An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer

A Phase 3 study testing Nivolumab in people with Various Advanced Cancer, run by Bristol-Myers Squibb at 188 sites in 30 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 purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Various Advanced Cancer
What is being tested?
Nivolumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
709 participants
Where
188 sitesin 30 countries
Study dates
22 Mar 2016to 19 May 2026
Phase
Phase 3

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

  • Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
  • Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
  • Must have disease free status as determined by imaging within 4 weeks of dosing
  • Tumor tissue must be provided for biomarker analysis
  • Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy

Who cannot join

  • Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
  • Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
  • Subjects with active, known or suspected autoimmune disease
  • Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
  • Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
  • Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection

Trial locations and contacts

188 sites in 30 countries.

188 sites in 30 countries

United States33 sites

  • Local Institution - 0176

    Albany, New York, 12208

  • Local Institution - 0074

    Allentown, Pennsylvania, 18103

  • Alaska Urological Institute dba Alaska Clinical Research Center

    Anchorage, Alaska, 99503

  • Local Institution - 0157

    Buffalo, New York, 14263

  • Local Institution - 0051

    Burnsville, Minnesota, 55337

  • Local Institution - 0166

    Chapel Hill, North Carolina, 27599-7305

  • Local Institution - 0009

    Chattanooga, Tennessee, 37404

  • Local Institution - 0061

    Clovis, California, 93611

  • Local Institution

    Durham, North Carolina, 27708

  • Local Institution - 0094

    Fort Wayne, Indiana, 46804

  • Local Institution - 0167

    Gainesville, Florida, 32610

  • Local Institution - 0173

    Grand Rapids, Michigan, 49503

  • Local Institution - 0178

    Lakewood, Colorado, 80228

  • Local Institution - 0177

    Las Vegas, Nevada, 89148

  • Local Institution - 0168

    Maywood, Illinois, 60153

  • Local Institution - 0030

    Miami Beach, Florida, 33140

  • Local Institution - 0007

    Mineola, New York, 11501

  • Local Institution - 0169

    Myrtle Beach, South Carolina, 29572

  • Local Institution - 0171

    New Orleans, Louisiana, 70112

  • Local Institution - 0001

    New York, New York, 10021

  • Local Institution - 0006

    New York, New York, 10029

  • Local Institution - 0234

    Norfolk, Virginia, 23502

  • Local Institution - 0003

    Omaha, Nebraska, 68130

  • Local Institution - 0011

    Pittsburgh, Pennsylvania, 15212

  • Local Institution - 0040

    Pittsburgh, Pennsylvania, 15232

  • Local Institution - 0044

    Portland, Oregon, 97213

  • Local Institution - 0010

    Portland, Oregon, 97239

  • Local Institution - 0004

    Rochester, Minnesota, 55905

  • Local Institution - 0172

    Sacramento, California, 95817

  • Local Institution - 0005

    San Francisco, California, 94115

  • Local Institution - 0008

    Tampa, Florida, 33612

  • Local Institution - 0180

    Tigard, Oregon, 97223

  • Local Institution - 0179

    Tucson, Arizona, 85704

Other trials in United States

China23 sites

  • Local Institution - 0191

    Beijing, Beijing Municipality, 100001

  • Local Institution - 0206

    Beijing, Beijing Municipality, 100034

  • Local Institution - 0192

    Beijing, Beijing Municipality, 100050

  • Local Institution - 0229

    Chengdu, Sichuan, 610041

  • Local Institution - 0219

    Chengdu, Sichuan, 610072

  • Local Institution - 0210

    Chongqing, Chongqing Municipality, 400030

  • Local Institution - 0198

    Fuzhou, Fujian, 350001

  • Local Institution - 0222

    Guangzhou, Guangdong, 510230

  • Local Institution - 0203

    Guangzhou, Guangdong, 510288

  • Local Institution - 0221

    Hangzhou, Zhejiang, 310009

  • Local Institution - 0195

    Hangzhou, Zhejiang, 310014

  • Local Institution - 0223

    Nanchang, Jiangxi, 330006

  • Local Institution - 0220

    Nanjing, Jiangsu, 210008

  • Local Institution - 0204

    Nanjing, Jiangsu, 210029

  • Local Institution - 0227

    Nanning, Guangxi, 530021

  • Local Institution - 0193

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0202

    Shanghai, Shanghai Municipality, 200032

  • Local Institution - 0199

    Shanghai, Shanghai Municipality, 200040

  • Local Institution - 0217

    Shanghai, Shanghai Municipality, 200040

  • Local Institution - 0230

    Wenzhou, Zhejiang, 32500

  • Local Institution - 0196

    Wuhan, Hubei, 430030

  • Local Institution

    Xi'an, Shan3xi, 710061

  • Local Institution - 0212

    Yantai, Shandong, 264000

Other trials in China

Japan16 sites

  • Local Institution - 0142

    Akita, Akita, 0108543

  • Local Institution - 0146

    Bunkyo-ku, Tokyo, 1138603

  • Local Institution - 0143

    Chiba, Chiba, 260-8717

  • Local Institution - 0162

    Fukuoka, Fukuoka, 8128582

  • Local Institution - 0151

    Hamamatasu, Shizuoka, 431-3192

  • Local Institution - 0144

    Hirosaki, Aomori, 0368563

  • Local Institution - 0163

    Nagasaki, Nagasaki, 8528501

  • Local Institution - 0150

    Niigata, Niigata, 9518520

  • Local Institution - 0141

    Okayama, Okayama-ken, 700-8558

  • Local Institution - 0164

    Osaka, Osaka, 5418567

  • Local Institution - 0160

    Sapporo, Hokkaido, 060-8543

  • Local Institution - 0161

    Sapporo, Hokkaido, 0608648

  • Local Institution - 0149

    Sayama, Osaka, 589-8511

  • Local Institution - 0147

    Shinjuku-ku, Tokyo, 1628666

  • Local Institution - 0145

    Shinjuku-Ku, Tokyo, 1608582

  • Local Institution - 0148

    Tsukuba, Ibaraki, 3058576

Other trials in Japan

Germany12 sites

  • Local Institution - 0131

    Chemnitz, 09130

  • Local Institution - 0125

    Essen, 45136

  • Local Institution - 0127

    Greifswald, 17475

  • Local Institution - 0126

    Hamburg, 20246

  • Local Institution - 0124

    Heidelberg, 69126

  • Local Institution - 0123

    Jena, 07747

  • Local Institution - 0188

    Marburg, 35043

  • Local Institution - 0122

    Munich, 81675

  • Local Institution - 0128

    Münster, 48149

  • Local Institution - 0185

    Nuremberg, 90419

  • Local Institution - 0130

    Regensburg, 93053

  • Local Institution - 0129

    Stuttgart, 70174

Other trials in Germany

Italy8 sites

  • Local Institution - 0088

    Arezzo, 52100

  • Local Institution - 0197

    Bergamo, 24127

  • Local Institution - 0082

    Milan, 20133

  • Local Institution - 0084

    Pisa, 56126

  • Local Institution - 0189

    Reggio Emilia, 42100

  • Local Institution - 0085

    Roma, 00144

  • Local Institution - 0086

    Roma, 00152

  • Local Institution - 0083

    Siena, 53100

Other trials in Italy

France7 sites

  • Local Institution - 0233

    Clermont-Ferrand, 63000

  • Local Institution - 0115

    La Roche-sur-Yon, 85000

  • Local Institution - 0080

    Marseille, 13273

  • Local Institution - 0081

    Paris, 75475

  • Local Institution - 0113

    Strasbourg, 67200

  • Local Institution - 0097

    Suresnes, 92151

  • Local Institution - 0098

    Villejuif, 94800

Other trials in France

Spain7 sites

  • Local Institution - 0067

    Badalona-barcelona, 08916

  • Local Institution - 0066

    Barcelona, 08035

  • Local Institution - 0064

    Madrid, 28007

  • Local Institution - 0062

    Madrid, 28034

  • Local Institution - 0063

    Madrid, 28041

  • Local Institution - 0232

    Santander, 39008

  • Local Institution - 0065

    Seville, 41013

Other trials in Spain

Argentina6 sites

  • Local Institution - 0021

    Berazategui, Buenos Aires, 1880

  • Local Institution - 0090

    Capital Federal, Buenos Aires, 1426

  • Local Institution - 0089

    Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181

  • Local Institution - 0022

    Ciudad Autónoma de BuenosAires, Buenos Aires, C1280AEB

  • Local Institution - 0020

    San Miguel de Tucumán, Tucumán Province, 4000

  • Local Institution - 0102

    Viedma, 8500

Other trials in Argentina

Australia6 sites

  • Local Institution - 0050

    Elizabeth Vale, South Australia, 5112

  • Local Institution - 0184

    Frankston, Victoria, 3199

  • Local Institution - 0048

    Liverpool, New South Wales, 2170

  • Local Institution - 0175

    Perth, Western Australia, 6150

  • Local Institution - 0047

    St Leonards, New South Wales, 2065

  • Local Institution - 0046

    Waratah, New South Wales, 2298

Other trials in Australia

Brazil6 sites

  • Local Institution - 0070

    Barretos, São Paulo, 14780-070

  • Local Institution - 0073

    Cerqueira César, São Paulo, 01246-000

  • Local Institution - 0071

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0072

    Porto Alegre, Rio Grande do Sul, 90610000

  • Local Institution - 0231

    Rio de Janeiro, Rio de Janeiro, 20231-050

  • Local Institution - 0100

    São Paulo, São Paulo, 04014-002

Other trials in Brazil

Mexico6 sites

  • Local Institution - 0138

    Df, Mexico City, 06720

  • Local Institution - 0035

    Guadalajara, Jalisco, 44270

  • Local Institution - 0116

    México, 06700

  • Local Institution - 0039

    México, 14080

  • Local Institution - 0034

    Mexico City, Mexico City, 14080

  • Local Institution - 0032

    Monterrey, Nuevo León, 64460

Other trials in Mexico

United Kingdom6 sites

  • Local Institution - 0076

    Edinburgh, Midlothian, EH4 2XU

  • Local Institution - 0114

    London, London, SW3 6JJ

  • Local Institution - 0036

    London, SE1 9RT

  • Local Institution - 0025

    Manchester, Greater Manchester, M20 4BX

  • Local Institution - 0059

    Sheffield, Yorkshire, S10 2SJ

  • Local Institution - 0024

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Poland5 sites

  • Local Institution - 0055

    Gdansk, 80-214

  • Local Institution - 0057

    Lodz, 93-513

  • Local Institution - 0187

    Warsaw, 02-797

  • Local Institution - 0058

    Wroclaw, 50-556

  • Local Institution - 0186

    Wroclaw, 53-413

Other trials in Poland

Austria4 sites

  • Local Institution - 0133

    Linz, 4010

  • Local Institution - 0136

    Salzburg, 5020

  • Local Institution - 0132

    Vienna, 1090

  • Local Institution - 0183

    Vienna, 1090

Other trials in Austria

Canada4 sites

  • Local Institution - 0139

    Edmonton, Alberta, T6G 1Z2

  • Local Institution - 0101

    Montreal, Quebec, H2X 0A9

  • Local Institution - 0109

    Montreal, Quebec, H4A 3J1

  • Local Institution - 0112

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Israel4 sites

  • Local Institution - 0118

    Haifa, 3109601

  • Local Institution - 0121

    Jerusalem, 91120

  • Local Institution - 0120

    Ramat Gan, 5262100

  • Local Institution - 0119

    Ẕerifin, 70300

Other trials in Israel

Romania4 sites

  • Local Institution - 0182

    Bucharest, 021389

  • Local Institution - 0096

    Craiova, 200347

  • Local Institution - 0078

    Floreşti, 407280

  • Local Institution - 0181

    Timisoara, Timis, 300239

Other trials in Romania

South Korea4 sites

  • Local Institution - 0155

    Seongnam-si, 13620

  • Local Institution - 0154

    Seoul, 03722

  • Local Institution - 0152

    Seoul, 05505

  • Local Institution - 0156

    Seoul, 06351

Other trials in South Korea

Chile3 sites

  • Local Institution - 0099

    Santiago, Santiago Metropolitan

  • Local Institution - 0137

    Temuco, 4810297

  • Local Institution - 0038

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Colombia3 sites

  • Local Institution - 0092

    Bogotá, 0

  • Local Institution - 0093

    Floridablanca, 681004

  • Local Institution - 0091

    Medellín, 050034

Other trials in Colombia

Denmark3 sites

  • Local Institution - 0108

    Aalborg, 9100

  • Local Institution - 0106

    Aarhus N, 8200

  • Local Institution - 0107

    Copenhagen, 2100

Other trials in Denmark

Netherlands3 sites

  • Local Institution - 0069

    Amsterdam, North Holland, 1081 HV

  • Local Institution - 0068

    Maastrict, 6229 HX

  • Local Institution - 0041

    Nijmegen, 6500 HB

Other trials in Netherlands

Taiwan3 sites

  • Local Institution - 0158

    Kaohsiung City, 807

  • Local Institution - 0159

    Taichung, 404

  • Local Institution - 0153

    Taipei, 100

Other trials in Taiwan

Belgium2 sites

  • Local Institution - 0029

    Hasselt, 3500

  • Local Institution - 0027

    Liège, 4000

Other trials in Belgium

Greece2 sites

  • Local Institution - 0110

    Athens, 115 28

  • Local Institution - 0111

    Thessaloniki, 54007

Other trials in Greece

Ireland2 sites

  • Local Institution - 0052

    Dublin, Dublin

  • Local Institution - 0054

    Wilton, CORK, 0

Other trials in Ireland

Russia2 sites

  • Local Institution - 0140

    Moscow, 125284

  • Local Institution - 0031

    Saint Petersburg, 197758

Other trials in Russia

Switzerland2 sites

  • Local Institution - 0134

    Basel, 4031

  • Local Institution - 0135

    Zurich, 8038

Other trials in Switzerland

Peru1 site

  • Local Institution - 0043

    Lima, Lima 41

Other trials in Peru

Sweden1 site

  • Local Institution - 0105

    Lund, 221 85

Other trials in Sweden

About this study

Official title: A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)

The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.

Being tested
Nivolumab, Placebo

What participants receive

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

Study groups in NCT02632409
Study groupRoleWhat they receive
NivolumabExperimentalNivolumab dose as specified
Receives: Biological: Nivolumab
PlaceboPlacebo comparatorPlacebo dose as specified
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)

    The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

    Measured: approximately up to 48 months

  2. Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population

    The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

    Measured: approximately up to 48 months

Secondary outcomes (6)

  1. Non-Urothelial Tract Recurrence Free Survival

    The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

    Measured: up to 53 months

  2. Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population

    The time between the date of randomization and the date of first documented recurrence (local non-urothelial tract or distant), or death due to any cause, whichever occurs first.

    Measured: up to 53 months

  3. Overall Survival

    the time from randomization to the date of death from any cause.

    Measured: on going

  4. Overall Survival in Participants With PD-L1 Expression ≥ 1%

    the time from randomization to the date of death from any cause.

    Measured: on going

  5. Disease Specific Survival

    the time from randomization to the date of death due to disease (urothelial cancer).

    Measured: on going

  6. Disease Specific Survival in Participants With PD-L1 Expression ≥ 1%

    the time from randomization to the date of death due to disease (urothelial cancer).

    Measured: on going

Timeline

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

  1. First posted16 Dec 2015 (estimated)
  2. Study start22 Mar 2016
  3. Primary completion17 Jul 2020
  4. Study completion19 May 2026

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
709 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02632409
Sponsor's protocol ID
CA209-274
Other IDs
2022-500630-29-00
Acronym
CheckMate 274
Status last verified
Jul 2026
First submitted
14 Dec 2015
Last updated
30 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Publications

  • Galsky MD, Bajorin DF, Tomita Y, Ye D, Agerbaek M, Enting D, Peer A, Milowsky M, Kobayashi K, Grimm MO, Stenner F, David JM, Li J, Chasalow SD, Nasroulah F, Apfel A, Unsal-Kacmaz K, Necchi A. Adjuvant nivolumab in muscle-invasive urothelial carcinoma: exploratory biomarker analysis of the randomized phase 3 CheckMate 274 trial. Nat Med. 2025 Sep;31(9):3062-3073. doi: 10.1038/s41591-025-03802-8. Epub 2025 Aug 7.

    PubMed 40775055

  • Geynisman DM, Chepynoga K, Yates G, Tate A, Kurt M, Patel MY, Teitsson S, Mitra S, Mamtani R. Estimating the Impact of Adjuvant Treatment With Nivolumab on Long-Term Survivorship Rates Compared With Surveillance in Muscle Invasive Urothelial Carcinoma: Mixture Cure Modeling Analyses of Disease-Free Survival From the Phase 3 CheckMate 274 Trial. Clin Genitourin Cancer. 2025 Jun;23(3):102335. doi: 10.1016/j.clgc.2025.102335. Epub 2025 Mar 17.

    PubMed 40204616

  • Galsky MD, Witjes JA, Gschwend JE, Milowsky MI, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Agerbaek M, Jha G, Stenner F, Ye D, Giudici F, Dutta S, Askelson M, Nasroulah F, Zhang J, Brophy L, Bajorin DF. Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274. J Clin Oncol. 2025 Jan;43(1):15-21. doi: 10.1200/JCO.24.00340. Epub 2024 Oct 11.

    PubMed 39393026

  • Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Antonio JN Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Treatment of muscle-invasive urothelial cancer with nivolumab (CheckMate 274 study): a plain language summary. Future Oncol. 2023 Feb;19(6):413-426. doi: 10.2217/fon-2022-1294. Epub 2023 Mar 15.

    PubMed 36919916

  • Witjes JA, Galsky MD, Gschwend JE, Broughton E, Braverman J, Nasroulah F, Maira-Arce M, Ye X, Shi L, Guo S, Hamilton M, Bajorin DF. Health-related Quality of Life with Adjuvant Nivolumab After Radical Resection for High-risk Muscle-invasive Urothelial Carcinoma: Results from the Phase 3 CheckMate 274 Trial. Eur Urol Oncol. 2022 Oct;5(5):553-563. doi: 10.1016/j.euo.2022.02.003. Epub 2022 Mar 11.

    PubMed 35288066

  • Bajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Neif Antonio J Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442.

    PubMed 34077643

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