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

NCT03661320 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CA017-0782024-512158-12
• Study Type: interventional
• Target: 855
• Locations: 27 countries
• Sites: 168

Brief 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).

Conditions

Urinary Bladder Neoplasms; Muscle-Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (2)

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

  Arm B vs. Arm A

  Approximately 43 months

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

  Arm B vs. Arm A

  Approximately 36 months

Secondary Outcomes (8)

• Overall Survival (OS) in all randomized participants

  Approximately 60 months

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

  Approximately 60 months

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

  Approximately 60 months

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

  Approximately 60 months

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

  Approximately 60 months

Study Arms (2)

Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy

ACTIVE COMPARATOR

Drug: Gemcitabine; Drug: Cisplatin

Arm B: Nivolumab + GC Chemotherapy

EXPERIMENTAL

Biological: Nivolumab; Drug: Gemcitabine; Drug: Cisplatin

Interventions

Gemcitabine DRUG

Specified dose on specified days

Also known as: Chemotherapy

Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy; Arm B: Nivolumab + GC Chemotherapy

Cisplatin DRUG

Specified dose on specified days

Also known as: Chemotherapy

Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy; Arm B: Nivolumab + GC Chemotherapy

Nivolumab BIOLOGICAL

Specified dose on specified days

Also known as: Opdivo, BMS-936558

Arm B: Nivolumab + GC Chemotherapy

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (172)

Local Institution - 0022

Tucson, Arizona, 85711, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Local Institution - 0021

Littleton, Colorado, 80120-4413, United States

Location

Local Institution - 0036

Pensacola, Florida, 32503, United States

Location

Local Institution - 0004

Tampa, Florida, 33612, United States

Location

Local Institution - 0144

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0005

Chicago, Illinois, 60637, United States

Location

Local Institution - 0006

Peoria, Illinois, 61615, United States

Location

Local Institution - 0181

Columbia, Maryland, 21044, United States

Location

Local Institution - 0009

Boston, Massachusetts, 02114, United States

Location

Local Institution - 0166

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0209

Boston, Massachusetts, 02215, United States

Location

Local Institution - 0025

Minneapolis, Minnesota, 55404, United States

Location

Local Institution - 0129

Minneapolis, Minnesota, 55455, United States

Location

Local Institution - 0183

Omaha, Nebraska, 68130, United States

Location

Local Institution - 0001

Omaha, Nebraska, 68198-6840, United States

Location

Local Institution - 0024

Las Vegas, Nevada, 89169, United States

Location

Local Institution - 0029

Albany, New York, 12208, United States

Location

Local Institution - 0069

Lake Success, New York, 11042, United States

Location

Local Institution - 0047

New York, New York, 10065, United States

Location

Local Institution - 0191

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0028

Tigard, Oregon, 97223, United States

Location

Local Institution - 0189

Charleston, South Carolina, 29425, United States

Location

Local Institution - 0007

Nashville, Tennessee, 37232, United States

Location

Local Institution - 0030

Austin, Texas, 78731, United States

Location

Local Institution - 0023

Norfolk, Virginia, 23502, United States

Location

Local Institution - 0051

Capital Federal, Buenos Aires, 1426, Argentina

Location

Local Institution - 0049

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280, Argentina

Location

Local Institution - 0151

Ciudad Autonoma Buenos Aires, Distrito Federal, 1118, Argentina

Location

Local Institution - 0131

Garran, Australian Capital Territory, 2605, Australia

Location

Local Institution - 0130

Kingswood, New South Wales, 2747, Australia

Location

Local Institution - 0157

Macquarie University, New South Wales, 2109, Australia

Location

Local Institution - 0043

St Leonards, New South Wales, 2065, Australia

Location

Local Institution - 0143

North Adelaide, South Australia, 5006, Australia

Location

Local Institution - 0037

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 0038

Murdoch, Western Australia, 6150, Australia

Location

Local Institution - 0090

Klagenfurt, 9020, Austria

Location

Local Institution - 0091

Krems, 3500, Austria

Location

Local Institution - 0011

Linz, 4020, Austria

Location

Local Institution - 0012

Vienna, 1090, Austria

Location

Local Institution - 0060

Brussels, 1200, Belgium

Location

Local Institution - 0063

Ghent, 9000, Belgium

Location

Local Institution - 0062

Wilrijk, 2610, Belgium

Location

Local Institution - 0094

Fortaleza, Ceará, 60130-241, Brazil

Location

Local Institution - 0099

Ipatinga, Minas Gerais, 35160-158, Brazil

Location

Local Institution - 0092

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

Location

Local Institution - 0212

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Local Institution - 0097

Porto Alegre, Rio Grande do Sul, 90610000, Brazil

Location

Local Institution - 0098

Barretos, São Paulo, 14780-070, Brazil

Location

Local Institution - 0095

Jaú, São Paulo, 17210-080, Brazil

Location

Local Institution - 0093

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

Location

Local Institution - 0164

Rio de Janeiro, 20231-050, Brazil

Location

Local Institution - 0214

São Paulo, 01221-020, Brazil

Location

Local Institution - 0159

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Local Institution - 0182

North York, Ontario, M2K 1E1, Canada

Location

Local Institution - 0192

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Local Institution - 0190

Montreal, Quebec, H3T 1M5, Canada

Location

Local Institution - 0053

Santiago, Santiago Metropolitan, 8330024, Chile

Location

Local Institution - 0052

Santiago, Santiago Metropolitan, 8380456, Chile

Location

Local Institution - 0210

Santiago, Santiago Metropolitan, 8420383, Chile

Location

Local Institution - 0054

Santiago, Santiago Metropolitan, Chile

Location

Local Institution - 0201

Colombia, Bogota D.C., 0, Colombia

Location

Local Institution - 0104

Bucaramanga, 681004, Colombia

Location

Local Institution - 0103

Montería, 230003, Colombia

Location

Local Institution - 0148

Helsinki, 00029, Finland

Location

Local Institution - 0145

Tampere, 33521, Finland

Location

Local Institution - 0146

Turku, 20251, Finland

Location

Local Institution - 0202

Brest, Finistère, 29609, France

Location

Local Institution - 0204

Créteil, Val-de-Marne, 94010, France

Location

Local Institution - 0205

Amiens, 80054, France

Location

Local Institution - 0198

Angers, 49100, France

Location

Local Institution - 0101

Besançon, 25000, France

Location

Local Institution - 0217

Bordeaux, 33076, France

Location

Local Institution - 0199

Clermont-Ferrand, 63000, France

Location

Local Institution - 0206

La Tronche, 38043, France

Location

Local Institution - 0075

Marseille, 13273, France

Location

Local Institution - 0200

Montpellier, 34298, France

Location

Local Institution - 0074

Nice, 06189, France

Location

Local Institution - 0163

Paris, 75014, France

Location

Local Institution - 0020

Pierre Benite Cedax, 69495, France

Location

Local Institution - 0188

Saint-Herblain, 44805, France

Location

Local Institution - 0002

Strasbourg, 67091, France

Location

Local Institution - 0003

Toulouse, 31059, France

Location

Local Institution - 0100

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Local Institution - 0078

Aachen, 52074, Germany

Location

Local Institution - 0015

Erfurt, 99028, Germany

Location

Local Institution - 0081

Essen, 45136, Germany

Location

Local Institution - 0086

Frankfurt am Main, 60590, Germany

Location

Local Institution - 0080

Göttingen, 37075, Germany

Location

Local Institution - 0013

Herne, 44625, Germany

Location

Local Institution - 0010

Jena, 07747, Germany

Location

Local Institution - 0084

Lübeck, 23538, Germany

Location

Local Institution - 0079

Magdeburg, 39120, Germany

Location

Local Institution - 0082

München, 81675, Germany

Location

Local Institution - 0016

Nuremberg, 90419, Germany

Location

Local Institution - 0085

Trier, 54292, Germany

Location

Local Institution - 0195

Athens, Attikí, 155 62, Greece

Location

Local Institution - 0031

Larissa, Thessalía, 411 10, Greece

Location

Local Institution - 0194

Chaïdári, 12462, Greece

Location

Local Institution - 0196

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Local Institution - 0068

Beersheba, 84101, Israel

Location

Local Institution - 0066

Haifa, 3109601, Israel

Location

Local Institution - 0067

Ramat Gan, 52621, Israel

Location

Local Institution - 0064

Bari, 70124, Italy

Location

Local Institution - 0193

Meldola (FC), 47014, Italy

Location

Local Institution - 0032

Milan, 20133, Italy

Location

Local Institution - 0065

Modena, 41012, Italy

Location

Local Institution - 0033

Padova, 35128, Italy

Location

Local Institution - 0034

Pisa, 56126, Italy

Location

Local Institution - 0035

Roma, 00168, Italy

Location

Local Institution - 0186

Komaki, Aichi-ken, 485-8520, Japan

Location

Local Institution - 0184

Sapporo, Hokkaido, 0030804, Japan

Location

Local Institution - 0177

Sapporo, Hokkaido, 060-8543, Japan

Location

Local Institution - 0185

Sapporo, Hokkaido, 0608604, Japan

Location

Local Institution - 0179

Tsukuba, Ibaraki, 3058576, Japan

Location

Local Institution - 0171

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Local Institution - 0169

Yokohama, Kanagawa, 222-0036, Japan

Location

Local Institution - 0168

Niigata, Niigata, 9518520, Japan

Location

Local Institution - 0173

Sayama, Osaka, 589-8511, Japan

Location

Local Institution - 0175

Takatsuki, Osaka, 569-8686, Japan

Location

Local Institution - 0176

Hidaka-shi, Saitama, 3501298, Japan

Location

Local Institution - 0170

Hamamatasu, Shizuoka, 431-3192, Japan

Location

Local Institution - 0178

Minato-ku, Tokyo, 1058470, Japan

Location

Local Institution - 0172

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Local Institution - 0174

Fukuoka, 812-8582, Japan

Location

Local Institution - 0180

Kyoto, 606-8507, Japan

Location

Local Institution - 0160

La Paz, BAJA Californa SUR, 23040, Mexico

Location

Local Institution - 0102

Zapopan, Jalisco, 45050, Mexico

Location

Local Institution - 0056

Monterrey, Nuevo León, 64460, Mexico

Location

Local Institution - 0105

Colima, 28017, Mexico

Location

Local Institution - 0070

Amsterdam, 1066 CX, Netherlands

Location

Local Institution - 0072

Groningen, 9713 GZ, Netherlands

Location

Local Institution - 0073

Sittard-Geleen, 6162 BG, Netherlands

Location

Local Institution - 0087

Auckland, 1023, New Zealand

Location

Local Institution - 0089

Christchurch, 8011, New Zealand

Location

Local Institution - 0158

Grålum, 1714, Norway

Location

Local Institution - 0132

Lorenskog, 1478, Norway

Location

Local Institution - 0133

Oslo, 0379, Norway

Location

Local Institution - 0153

Lisbon, 1649-035, Portugal

Location

Local Institution - 0152

Porto, 4200-072, Portugal

Location

Local Institution - 0219

Cluj-Napoca, 400015, Romania

Location

Local Institution - 0076

Craiova, 200542, Romania

Location

Local Institution - 0058

Sector 2, 022328, Romania

Location

Local Institution

Saint Petersburg, 194044, Russia

Location

Local Institution

Saint Petersburg, 197758, Russia

Location

Local Institution - 0154

Singapore, 168583, Singapore

Location

Local Institution - 0137

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Local Institution - 0203

Seongnam-si, Kyǒnggi-do, 13620, South Korea

Location

Local Institution - 0220

Busan, 48108, South Korea

Location

Local Institution - 0218

Daegu, 41404, South Korea

Location

Local Institution - 0208

Gyeongsangnam-do, 50612, South Korea

Location

Local Institution - 0215

Seongnam-si, 13496, South Korea

Location

Local Institution - 0140

Seoul, 02841, South Korea

Location

Local Institution - 0136

Seoul, 03080, South Korea

Location

Local Institution - 0211

Seoul, 05505, South Korea

Location

Local Institution - 0138

Seoul, 06351, South Korea

Location

Local Institution - 0113

Lugo, 27003, Spain

Location

Local Institution - 0111

Madrid, 28007, Spain

Location

Local Institution - 0112

Madrid, 28033, Spain

Location

Local Institution - 0114

Madrid, 28041, Spain

Location

Local Institution - 0156

Málaga, 29010, Spain

Location

Local Institution - 0109

Seville, 41013, Spain

Location

Local Institution - 0135

Kaohsiung City, 833401, Taiwan

Location

Local Institution - 0165

Taichung, 407219, Taiwan

Location

Local Institution - 0141

Taipei, 100229, Taiwan

Location

Local Institution - 0139

Taipei, 11217, Taiwan

Location

Local Institution - 0128

Chelmsford, Essex, CM1 7ET, United Kingdom

Location

Local Institution - 0127

York, Yorkshire, YO31 8HE, United Kingdom

Location

Local Institution - 0122

Glasgow, G12 0YN, United Kingdom

Location

Local Institution - 0117

Lancaster, LA1 4RP, United Kingdom

Location

Local Institution - 0121

London, SE1 9RT, United Kingdom

Location

Local Institution - 0124

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 38155060 DERIVED

• 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.

  PMID: 31823654 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Nivolumab; Gemcitabine; Drug Therapy; Cisplatin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 7, 2018
• Study Start: November 6, 2018
• Primary Completion: February 16, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

JP (16); CO (3); RO (3); KR (10); CL (4); CA (4); ES (6); RU (2); IT (7); NO (3); GB (6); NL (3); TW (4); SG (1); US (26); FR (16); DE (13); AU (7); ME (4); AR (3); IL (4); NZ (2); FI (3); BE (3); BR (10); GR (3); PT (2)