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AzTrials

Urinary Bladder NeoplasmsPhase 3NCT03661320

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

A Phase 3 study testing Nivolumab, Gemcitabine and Cisplatin in people with Urinary Bladder Neoplasms and Muscle-Invasive Bladder Cancer, run by Bristol-Myers Squibb at 172 sites in 28 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 compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab, Gemcitabine and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
855 participants
Where
172 sitesin 28 countries
Study dates
6 Nov 2018to 14 Apr 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Participant must be deemed eligible for Radial Cystectomy (RC) by his/her oncologist and/or urologist, and must agree to undergo Radial Cystectomy (RC) after completion of neoadjuvant therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Who cannot join

  • Clinical evidence of positive lymph node(s) (LN) (≥ 10 mm in short axis) or metastatic bladder cancer
  • Prior systemic therapy, radiation therapy, or surgery for bladder cancer other than trans urethral resection of bladder tumor (TURBT) or biopsies is also not permitted

Trial locations and contacts

172 sites in 28 countries.

172 sites in 28 countries

United States26 sites

  • Local Institution - 0029

    Albany, New York, 12208

  • Local Institution - 0144

    Atlanta, Georgia, 30342

  • Local Institution - 0030

    Austin, Texas, 78731

  • Local Institution - 0009

    Boston, Massachusetts, 02114

  • Local Institution - 0166

    Boston, Massachusetts, 02215

  • Local Institution - 0209

    Boston, Massachusetts, 02215

  • Local Institution - 0189

    Charleston, South Carolina, 29425

  • Local Institution - 0005

    Chicago, Illinois, 60637

  • Local Institution - 0191

    Cleveland, Ohio, 44195

  • Local Institution - 0181

    Columbia, Maryland, 21044

  • Local Institution - 0069

    Lake Success, New York, 11042

  • Local Institution - 0024

    Las Vegas, Nevada, 89169

  • Local Institution - 0021

    Littleton, Colorado, 80120-4413

  • Local Institution - 0025

    Minneapolis, Minnesota, 55404

  • Local Institution - 0129

    Minneapolis, Minnesota, 55455

  • Local Institution - 0007

    Nashville, Tennessee, 37232

  • Local Institution - 0047

    New York, New York, 10065

  • Local Institution - 0023

    Norfolk, Virginia, 23502

  • Local Institution - 0183

    Omaha, Nebraska, 68130

  • Local Institution - 0001

    Omaha, Nebraska, 68198-6840

  • Local Institution - 0036

    Pensacola, Florida, 32503

  • Local Institution - 0006

    Peoria, Illinois, 61615

  • UC Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Local Institution - 0004

    Tampa, Florida, 33612

  • Local Institution - 0028

    Tigard, Oregon, 97223

  • Local Institution - 0022

    Tucson, Arizona, 85711

Other trials in United States

France16 sites

  • Local Institution - 0205

    Amiens, 80054

  • Local Institution - 0198

    Angers, 49100

  • Local Institution - 0101

    Besançon, 25000

  • Local Institution - 0217

    Bordeaux, 33076

  • Local Institution - 0202

    Brest, Finistère, 29609

  • Local Institution - 0199

    Clermont-Ferrand, 63000

  • Local Institution - 0204

    Créteil, Val-de-Marne, 94010

  • Local Institution - 0206

    La Tronche, 38043

  • Local Institution - 0075

    Marseille, 13273

  • Local Institution - 0200

    Montpellier, 34298

  • Local Institution - 0074

    Nice, 06189

  • Local Institution - 0163

    Paris, 75014

  • Local Institution - 0020

    Pierre Benite Cedax, 69495

  • Local Institution - 0188

    Saint-Herblain, 44805

  • Local Institution - 0002

    Strasbourg, 67091

  • Local Institution - 0003

    Toulouse, 31059

Other trials in France

Japan16 sites

  • Local Institution - 0174

    Fukuoka, 812-8582

  • Local Institution - 0170

    Hamamatasu, Shizuoka, 431-3192

  • Local Institution - 0176

    Hidaka-shi, Saitama, 3501298

  • Local Institution - 0171

    Kita-gun, Kagawa-ken, 761-0793

  • Local Institution - 0186

    Komaki, Aichi-ken, 485-8520

  • Local Institution - 0180

    Kyoto, 606-8507

  • Local Institution - 0178

    Minato-ku, Tokyo, 1058470

  • Local Institution - 0168

    Niigata, Niigata, 9518520

  • Local Institution - 0184

    Sapporo, Hokkaido, 0030804

  • Local Institution - 0177

    Sapporo, Hokkaido, 060-8543

  • Local Institution - 0185

    Sapporo, Hokkaido, 0608604

  • Local Institution - 0173

    Sayama, Osaka, 589-8511

  • Local Institution - 0172

    Shinjuku-ku, Tokyo, 160-8582

  • Local Institution - 0175

    Takatsuki, Osaka, 569-8686

  • Local Institution - 0179

    Tsukuba, Ibaraki, 3058576

  • Local Institution - 0169

    Yokohama, Kanagawa, 222-0036

Other trials in Japan

Germany13 sites

  • Local Institution - 0078

    Aachen, 52074

  • Local Institution - 0015

    Erfurt, 99028

  • Local Institution - 0081

    Essen, 45136

  • Local Institution - 0086

    Frankfurt am Main, 60590

  • Local Institution - 0080

    Göttingen, 37075

  • Local Institution - 0013

    Herne, 44625

  • Local Institution - 0010

    Jena, 07747

  • Local Institution - 0084

    Lübeck, 23538

  • Local Institution - 0079

    Magdeburg, 39120

  • Local Institution - 0100

    Mainz, Rhineland-Palatinate, 55131

  • Local Institution - 0082

    München, 81675

  • Local Institution - 0016

    Nuremberg, 90419

  • Local Institution - 0085

    Trier, 54292

Other trials in Germany

Brazil10 sites

  • Local Institution - 0098

    Barretos, São Paulo, 14780-070

  • Local Institution - 0094

    Fortaleza, Ceará, 60130-241

  • Local Institution - 0092

    Ijuí, Rio Grande do Sul, 98700-000

  • Local Institution - 0099

    Ipatinga, Minas Gerais, 35160-158

  • Local Institution - 0095

    Jaú, São Paulo, 17210-080

  • Local Institution - 0212

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Local Institution - 0097

    Porto Alegre, Rio Grande do Sul, 90610000

  • Local Institution - 0164

    Rio de Janeiro, 20231-050

  • Local Institution - 0093

    São José do Rio Preto, São Paulo, 15090-000

  • Local Institution - 0214

    São Paulo, 01221-020

Other trials in Brazil

South Korea10 sites

  • Local Institution - 0220

    Busan, 48108

  • Local Institution - 0218

    Daegu, 41404

  • Local Institution - 0137

    Goyang-si, Gyeonggi-do, 10408

  • Local Institution - 0208

    Gyeongsangnam-do, 50612

  • Local Institution - 0203

    Seongnam-si, Kyǒnggi-do, 13620

  • Local Institution - 0215

    Seongnam-si, 13496

  • Local Institution - 0140

    Seoul, 02841

  • Local Institution - 0136

    Seoul, 03080

  • Local Institution - 0211

    Seoul, 05505

  • Local Institution - 0138

    Seoul, 06351

Other trials in South Korea

Australia7 sites

  • Local Institution - 0131

    Garran, Australian Capital Territory, 2605

  • Local Institution - 0037

    Heidelberg, Victoria, 3084

  • Local Institution - 0130

    Kingswood, New South Wales, 2747

  • Local Institution - 0157

    Macquarie University, New South Wales, 2109

  • Local Institution - 0038

    Murdoch, Western Australia, 6150

  • Local Institution - 0143

    North Adelaide, South Australia, 5006

  • Local Institution - 0043

    St Leonards, New South Wales, 2065

Other trials in Australia

Italy7 sites

  • Local Institution - 0064

    Bari, 70124

  • Local Institution - 0193

    Meldola (FC), 47014

  • Local Institution - 0032

    Milan, 20133

  • Local Institution - 0065

    Modena, 41012

  • Local Institution - 0033

    Padova, 35128

  • Local Institution - 0034

    Pisa, 56126

  • Local Institution - 0035

    Roma, 00168

Other trials in Italy

Spain6 sites

  • Local Institution - 0113

    Lugo, 27003

  • Local Institution - 0111

    Madrid, 28007

  • Local Institution - 0112

    Madrid, 28033

  • Local Institution - 0114

    Madrid, 28041

  • Local Institution - 0156

    Málaga, 29010

  • Local Institution - 0109

    Seville, 41013

Other trials in Spain

United Kingdom6 sites

  • Local Institution - 0128

    Chelmsford, Essex, CM1 7ET

  • Local Institution - 0122

    Glasgow, G12 0YN

  • Local Institution - 0117

    Lancaster, LA1 4RP

  • Local Institution - 0121

    London, SE1 9RT

  • Local Institution - 0124

    Oxford, OX3 7LE

  • Local Institution - 0127

    York, Yorkshire, YO31 8HE

Other trials in United Kingdom

Austria4 sites

  • Local Institution - 0090

    Klagenfurt, 9020

  • Local Institution - 0091

    Krems, 3500

  • Local Institution - 0011

    Linz, 4020

  • Local Institution - 0012

    Vienna, 1090

Other trials in Austria

Canada4 sites

  • Local Institution - 0192

    Chicoutimi, Quebec, G7H 5H6

  • Local Institution - 0159

    Kelowna, British Columbia, V1Y 5L3

  • Local Institution - 0190

    Montreal, Quebec, H3T 1M5

  • Local Institution - 0182

    North York, Ontario, M2K 1E1

Other trials in Canada

Chile4 sites

  • Local Institution - 0053

    Santiago, Santiago Metropolitan, 8330024

  • Local Institution - 0052

    Santiago, Santiago Metropolitan, 8380456

  • Local Institution - 0210

    Santiago, Santiago Metropolitan, 8420383

  • Local Institution - 0054

    Santiago, Santiago Metropolitan

Other trials in Chile

Israel4 sites

  • Local Institution - 0068

    Beersheba, 84101

  • Local Institution - 0066

    Haifa, 3109601

  • Local Institution - 0067

    Ramat Gan, 52621

  • Local Institution - 0196

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Mexico4 sites

  • Local Institution - 0105

    Colima, 28017

  • Local Institution - 0160

    La Paz, BAJA Californa SUR, 23040

  • Local Institution - 0056

    Monterrey, Nuevo León, 64460

  • Local Institution - 0102

    Zapopan, Jalisco, 45050

Other trials in Mexico

Taiwan4 sites

  • Local Institution - 0135

    Kaohsiung City, 833401

  • Local Institution - 0165

    Taichung, 407219

  • Local Institution - 0141

    Taipei, 100229

  • Local Institution - 0139

    Taipei, 11217

Other trials in Taiwan

Argentina3 sites

  • Local Institution - 0051

    Capital Federal, Buenos Aires, 1426

  • Local Institution - 0151

    Ciudad Autonoma Buenos Aires, Distrito Federal, 1118

  • Local Institution - 0049

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280

Other trials in Argentina

Belgium3 sites

  • Local Institution - 0060

    Brussels, 1200

  • Local Institution - 0063

    Ghent, 9000

  • Local Institution - 0062

    Wilrijk, 2610

Other trials in Belgium

Colombia3 sites

  • Local Institution - 0104

    Bucaramanga, 681004

  • Local Institution - 0201

    Colombia, Bogota D.C., 0

  • Local Institution - 0103

    Montería, 230003

Other trials in Colombia

Finland3 sites

  • Local Institution - 0148

    Helsinki, 00029

  • Local Institution - 0145

    Tampere, 33521

  • Local Institution - 0146

    Turku, 20251

Other trials in Finland

Greece3 sites

  • Local Institution - 0195

    Athens, Attikí, 155 62

  • Local Institution - 0194

    Chaïdári, 12462

  • Local Institution - 0031

    Larissa, Thessalía, 411 10

Other trials in Greece

Netherlands3 sites

  • Local Institution - 0070

    Amsterdam, 1066 CX

  • Local Institution - 0072

    Groningen, 9713 GZ

  • Local Institution - 0073

    Sittard-Geleen, 6162 BG

Other trials in Netherlands

Norway3 sites

  • Local Institution - 0158

    Grålum, 1714

  • Local Institution - 0132

    Lorenskog, 1478

  • Local Institution - 0133

    Oslo, 0379

Other trials in Norway

Romania3 sites

  • Local Institution - 0219

    Cluj-Napoca, 400015

  • Local Institution - 0076

    Craiova, 200542

  • Local Institution - 0058

    Sector 2, 022328

Other trials in Romania

New Zealand2 sites

  • Local Institution - 0087

    Auckland, 1023

  • Local Institution - 0089

    Christchurch, 8011

Other trials in New Zealand

Portugal2 sites

  • Local Institution - 0153

    Lisbon, 1649-035

  • Local Institution - 0152

    Porto, 4200-072

Other trials in Portugal

Russia2 sites

  • Local Institution

    Saint Petersburg, 194044

  • Local Institution

    Saint Petersburg, 197758

Other trials in Russia

Singapore1 site

  • Local Institution - 0154

    Singapore, 168583

Other trials in Singapore

About this study

Official title: A Phase 3, Randomized, Study of Neoadjuvant Chemotherapy Alone Versus Neoadjuvant Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Post- Surgery Therapy With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle- Invasive Bladder Cancer

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

Medical subject headings
Urinary Bladder Neoplasms

What participants receive

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

  • NivolumabBiological

    Also called Opdivo, BMS-936558

    Specified dose on specified days

  • GemcitabineDrug

    Also called Chemotherapy

    Specified dose on specified days

  • CisplatinDrug

    Also called Chemotherapy

    Specified dose on specified days

Study groups in NCT03661320
Study groupRoleWhat they receive
Arm A: Gemcitabine/Cisplatin (GC) ChemotherapyActive comparatorNot described
Receives: Drug: Gemcitabine; Drug: Cisplatin
Arm B: Nivolumab + GC ChemotherapyExperimentalNot described
Receives: Biological: Nivolumab; Drug: Gemcitabine; Drug: Cisplatin

What is being measured

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

  1. Pathological Complete Response (pCR) rate, in all randomized participants

    Arm B vs. Arm A

    Measured: Approximately 43 months

  2. Event-Free Survival (EFS), in all randomized participants

    Arm B vs. Arm A

    Measured: Approximately 36 months

Secondary outcomes (8)

  1. Overall Survival (OS) in all randomized participants

    Arm B vs. Arm A

    Measured: Approximately 60 months

  2. Incidence of Adverse Events (AE) in participants who received at least one treatment dose

    Measured: Approximately 60 months

  3. Incidence of Serious Adverse Events (SAE) in participants who received at least one treatment dose

    Measured: Approximately 60 months

  4. Incidence of deaths in participants who received at least one treatment dose

    Measured: Approximately 60 months

  5. Incidence of laboratory abnormalities in participants who received at least one treatment dose

    Measured: Approximately 60 months

  6. pCR rate, descriptively in all concurrently randomized participants

    Arm C vs. Arm B and Arm A

    Measured: Approximately 43 months

  7. EFS, descriptively in all concurrently randomized participants

    Arm C vs. Arm B and Arm A

    Measured: Approximately 36 months

  8. OS, descriptively in all concurrently randomized participants

    Arm C vs. Arm B and Arm A

    Measured: Approximately 60 months

Timeline

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

  1. First posted7 Sep 2018
  2. Study start6 Nov 2018
  3. Primary completion16 Feb 2026
  4. Study completion14 Apr 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
None (open label)
Enrolment
855 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03661320
Sponsor's protocol ID
CA017-078
Other IDs
2024-512158-12
Status last verified
Sep 2026
First submitted
5 Sep 2018
Last updated
10 Sep 2026
Results posted
No
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

  • Grivas P, Koshkin VS, Chu X, Cole S, Jain RK, Dreicer R, Cetnar JP, Sundi D, Gartrell BA, Galsky MD, Woo B, Li-Ning-Tapia E, Hahn NM, Carducci MA. PrECOG PrE0807: A Phase 1b Feasibility Trial of Neoadjuvant Nivolumab Without and with Lirilumab in Patients with Muscle-invasive Bladder Cancer Ineligible for or Refusing Cisplatin-based Neoadjuvant Chemotherapy. Eur Urol Oncol. 2024 Aug;7(4):914-922. doi: 10.1016/j.euo.2023.11.022. Epub 2023 Dec 27.

    PubMed 38155060

  • Sonpavde G, Necchi A, Gupta S, Steinberg GD, Gschwend JE, Van Der Heijden MS, Garzon N, Ibrahim M, Raybold B, Liaw D, Rutstein M, Galsky MD. ENERGIZE: a Phase III study of neoadjuvant chemotherapy alone or with nivolumab with/without linrodostat mesylate for muscle-invasive bladder cancer. Future Oncol. 2020 Jan;16(2):4359-4368. doi: 10.2217/fon-2019-0611. Epub 2019 Dec 11.

    PubMed 31823654

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Gemcitabine and Cisplatin in people with Urinary Bladder Neoplasms and Muscle-Invasive Bladder Cancer, run by Bristol-Myers Squibb at 172 sites in 28 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 2 inclusion and 2 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 172 sites in United States, France, Japan, Germany, Brazil and 23 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pathological Complete Response (pCR) rate, in all randomized participants (time frame: Approximately 43 months). The study lists 2 primary outcomes in all. 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 NCT03661320, which also lists 2 linked publications.

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 10 Sep 2026.

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