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

NCT ID: NCT03661320

Last Updated: 2026-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

855 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-06

Study Completion Date

2027-12-30

Brief Summary

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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).

Detailed Description

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Conditions

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Urinary Bladder Neoplasms Muscle-Invasive Bladder Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: Gemcitabine/Cisplatin (GC) Chemotherapy

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Arm B: Nivolumab + GC Chemotherapy

Group Type EXPERIMENTAL

Nivolumab

Intervention Type BIOLOGICAL

Specified dose on specified days

Gemcitabine

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Interventions

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Nivolumab

Specified dose on specified days

Intervention Type BIOLOGICAL

Gemcitabine

Specified dose on specified days

Intervention Type DRUG

Cisplatin

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Opdivo BMS-936558 Chemotherapy Chemotherapy

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0022

Tucson, Arizona, United States

Site Status

UC Davis Comprehensive Cancer Center

Sacramento, California, United States

Site Status

Local Institution - 0021

Littleton, Colorado, United States

Site Status

Local Institution - 0036

Pensacola, Florida, United States

Site Status

Local Institution - 0004

Tampa, Florida, United States

Site Status

Local Institution - 0144

Atlanta, Georgia, United States

Site Status

Local Institution - 0005

Chicago, Illinois, United States

Site Status

Local Institution - 0006

Peoria, Illinois, United States

Site Status

Local Institution - 0181

Columbia, Maryland, United States

Site Status

Local Institution - 0009

Boston, Massachusetts, United States

Site Status

Local Institution - 0166

Boston, Massachusetts, United States

Site Status

Local Institution - 0209

Boston, Massachusetts, United States

Site Status

Local Institution - 0025

Minneapolis, Minnesota, United States

Site Status

Local Institution - 0129

Minneapolis, Minnesota, United States

Site Status

Local Institution - 0183

Omaha, Nebraska, United States

Site Status

Local Institution - 0001

Omaha, Nebraska, United States

Site Status

Local Institution - 0024

Las Vegas, Nevada, United States

Site Status

Local Institution - 0029

Albany, New York, United States

Site Status

Local Institution - 0069

Lake Success, New York, United States

Site Status

Local Institution - 0047

New York, New York, United States

Site Status

Local Institution - 0191

Cleveland, Ohio, United States

Site Status

Local Institution - 0028

Tigard, Oregon, United States

Site Status

Local Institution - 0189

Charleston, South Carolina, United States

Site Status

Local Institution - 0007

Nashville, Tennessee, United States

Site Status

Local Institution - 0030

Austin, Texas, United States

Site Status

Local Institution - 0023

Norfolk, Virginia, United States

Site Status

Local Institution - 0051

Capital Federal, Buenos Aires, Argentina

Site Status

Local Institution - 0049

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Local Institution - 0151

Ciudad Autonoma Buenos Aires, Distrito Federal, Argentina

Site Status

Local Institution - 0131

Garran, Australian Capital Territory, Australia

Site Status

Local Institution - 0130

Kingswood, New South Wales, Australia

Site Status

Local Institution - 0157

Macquarie University, New South Wales, Australia

Site Status

Local Institution - 0043

St Leonards, New South Wales, Australia

Site Status

Local Institution - 0143

North Adelaide, South Australia, Australia

Site Status

Local Institution - 0037

Heidelberg, Victoria, Australia

Site Status

Local Institution - 0038

Murdoch, Western Australia, Australia

Site Status

Local Institution - 0090

Klagenfurt, , Austria

Site Status

Local Institution - 0091

Krems, , Austria

Site Status

Local Institution - 0011

Linz, , Austria

Site Status

Local Institution - 0012

Vienna, , Austria

Site Status

Local Institution - 0060

Brussels, , Belgium

Site Status

Local Institution - 0063

Ghent, , Belgium

Site Status

Local Institution - 0062

Wilrijk, , Belgium

Site Status

Local Institution - 0094

Fortaleza, Ceará, Brazil

Site Status

Local Institution - 0099

Ipatinga, Minas Gerais, Brazil

Site Status

Local Institution - 0092

Ijuí, Rio Grande do Sul, Brazil

Site Status

Local Institution - 0212

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Local Institution - 0097

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Local Institution - 0098

Barretos, São Paulo, Brazil

Site Status

Local Institution - 0095

Jaú, São Paulo, Brazil

Site Status

Local Institution - 0093

São José do Rio Preto, São Paulo, Brazil

Site Status

Local Institution - 0164

Rio de Janeiro, , Brazil

Site Status

Local Institution - 0214

São Paulo, , Brazil

Site Status

Local Institution - 0159

Kelowna, British Columbia, Canada

Site Status

Local Institution - 0182

North York, Ontario, Canada

Site Status

Local Institution - 0192

Chicoutimi, Quebec, Canada

Site Status

Local Institution - 0190

Montreal, Quebec, Canada

Site Status

Local Institution - 0053

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0052

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0210

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0054

Santiago, Santiago Metropolitan, Chile

Site Status

Local Institution - 0201

Colombia, Bogota D.C., Colombia

Site Status

Local Institution - 0104

Bucaramanga, , Colombia

Site Status

Local Institution - 0103

Montería, , Colombia

Site Status

Local Institution - 0148

Helsinki, , Finland

Site Status

Local Institution - 0145

Tampere, , Finland

Site Status

Local Institution - 0146

Turku, , Finland

Site Status

Local Institution - 0202

Brest, Finistère, France

Site Status

Local Institution - 0204

Créteil, Val-de-Marne, France

Site Status

Local Institution - 0205

Amiens, , France

Site Status

Local Institution - 0198

Angers, , France

Site Status

Local Institution - 0101

Besançon, , France

Site Status

Local Institution - 0217

Bordeaux, , France

Site Status

Local Institution - 0199

Clermont-Ferrand, , France

Site Status

Local Institution - 0206

La Tronche, , France

Site Status

Local Institution - 0075

Marseille, , France

Site Status

Local Institution - 0200

Montpellier, , France

Site Status

Local Institution - 0074

Nice, , France

Site Status

Local Institution - 0163

Paris, , France

Site Status

Local Institution - 0020

Pierre Benite Cedax, , France

Site Status

Local Institution - 0188

Saint-Herblain, , France

Site Status

Local Institution - 0002

Strasbourg, , France

Site Status

Local Institution - 0003

Toulouse, , France

Site Status

Local Institution - 0100

Mainz, Rhineland-Palatinate, Germany

Site Status

Local Institution - 0078

Aachen, , Germany

Site Status

Local Institution - 0015

Erfurt, , Germany

Site Status

Local Institution - 0081

Essen, , Germany

Site Status

Local Institution - 0086

Frankfurt am Main, , Germany

Site Status

Local Institution - 0080

Göttingen, , Germany

Site Status

Local Institution - 0013

Herne, , Germany

Site Status

Local Institution - 0010

Jena, , Germany

Site Status

Local Institution - 0084

Lübeck, , Germany

Site Status

Local Institution - 0079

Magdeburg, , Germany

Site Status

Local Institution - 0082

München, , Germany

Site Status

Local Institution - 0016

Nuremberg, , Germany

Site Status

Local Institution - 0085

Trier, , Germany

Site Status

Local Institution - 0195

Athens, Attikí, Greece

Site Status

Local Institution - 0031

Larissa, Thessalía, Greece

Site Status

Local Institution - 0194

Chaïdári, , Greece

Site Status

Local Institution - 0196

Tel Aviv, Tel Aviv, Israel

Site Status

Local Institution - 0068

Beersheba, , Israel

Site Status

Local Institution - 0066

Haifa, , Israel

Site Status

Local Institution - 0067

Ramat Gan, , Israel

Site Status

Local Institution - 0064

Bari, , Italy

Site Status

Local Institution - 0193

Meldola (FC), , Italy

Site Status

Local Institution - 0032

Milan, , Italy

Site Status

Local Institution - 0065

Modena, , Italy

Site Status

Local Institution - 0033

Padua, , Italy

Site Status

Local Institution - 0034

Pisa, , Italy

Site Status

Local Institution - 0035

Roma, , Italy

Site Status

Local Institution - 0186

Komaki, Aichi-ken, Japan

Site Status

Local Institution - 0184

Sapporo, Hokkaido, Japan

Site Status

Local Institution - 0177

Sapporo, Hokkaido, Japan

Site Status

Local Institution - 0185

Sapporo, Hokkaido, Japan

Site Status

Local Institution - 0179

Tsukuba, Ibaraki, Japan

Site Status

Local Institution - 0171

Kita-gun, Kagawa-ken, Japan

Site Status

Local Institution - 0169

Yokohama, Kanagawa, Japan

Site Status

Local Institution - 0168

Niigata, Niigata, Japan

Site Status

Local Institution - 0173

Sayama, Osaka, Japan

Site Status

Local Institution - 0175

Takatsuki, Osaka, Japan

Site Status

Local Institution - 0176

Hidaka-shi, Saitama, Japan

Site Status

Local Institution - 0170

Hamamatasu, Shizuoka, Japan

Site Status

Local Institution - 0178

Minato-ku, Tokyo, Japan

Site Status

Local Institution - 0172

Shinjuku-ku, Tokyo, Japan

Site Status

Local Institution - 0174

Fukuoka, , Japan

Site Status

Local Institution - 0180

Kyoto, , Japan

Site Status

Local Institution - 0160

La Paz, BAJA Californa SUR, Mexico

Site Status

Local Institution - 0102

Zapopan, Jalisco, Mexico

Site Status

Local Institution - 0056

Monterrey, Nuevo León, Mexico

Site Status

Local Institution - 0105

Colima, , Mexico

Site Status

Local Institution - 0070

Amsterdam, , Netherlands

Site Status

Local Institution - 0072

Groningen, , Netherlands

Site Status

Local Institution - 0073

Sittard-Geleen, , Netherlands

Site Status

Local Institution - 0087

Auckland, , New Zealand

Site Status

Local Institution - 0089

Christchurch, , New Zealand

Site Status

Local Institution - 0158

Grålum, , Norway

Site Status

Local Institution - 0132

Lorenskog, , Norway

Site Status

Local Institution - 0133

Oslo, , Norway

Site Status

Local Institution - 0153

Lisbon, , Portugal

Site Status

Local Institution - 0152

Porto, , Portugal

Site Status

Local Institution - 0219

Cluj-Napoca, , Romania

Site Status

Local Institution - 0076

Craiova, , Romania

Site Status

Local Institution - 0058

Sector 2, , Romania

Site Status

Local Institution

Saint Petersburg, , Russia

Site Status

Local Institution

Saint Petersburg, , Russia

Site Status

Local Institution - 0154

Singapore, , Singapore

Site Status

Local Institution - 0137

Goyang-si, Gyeonggi-do, South Korea

Site Status

Local Institution - 0203

Seongnam-si, Kyǒnggi-do, South Korea

Site Status

Local Institution - 0220

Busan, , South Korea

Site Status

Local Institution - 0218

Daegu, , South Korea

Site Status

Local Institution - 0208

Gyeongsangnam-do, , South Korea

Site Status

Local Institution - 0215

Seongnam-si, , South Korea

Site Status

Local Institution - 0140

Seoul, , South Korea

Site Status

Local Institution - 0136

Seoul, , South Korea

Site Status

Local Institution - 0211

Seoul, , South Korea

Site Status

Local Institution - 0138

Seoul, , South Korea

Site Status

Local Institution - 0113

Lugo, , Spain

Site Status

Local Institution - 0111

Madrid, , Spain

Site Status

Local Institution - 0112

Madrid, , Spain

Site Status

Local Institution - 0114

Madrid, , Spain

Site Status

Local Institution - 0156

Málaga, , Spain

Site Status

Local Institution - 0109

Seville, , Spain

Site Status

Local Institution - 0135

Kaohsiung City, , Taiwan

Site Status

Local Institution - 0165

Taichung, , Taiwan

Site Status

Local Institution - 0141

Taipei, , Taiwan

Site Status

Local Institution - 0139

Taipei, , Taiwan

Site Status

Local Institution - 0128

Chelmsford, Essex, United Kingdom

Site Status

Local Institution - 0127

York, Yorkshire, United Kingdom

Site Status

Local Institution - 0122

Glasgow, , United Kingdom

Site Status

Local Institution - 0117

Lancaster, , United Kingdom

Site Status

Local Institution - 0121

London, , United Kingdom

Site Status

Local Institution - 0124

Oxford, , United Kingdom

Site Status

Countries

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United States Argentina Australia Austria Belgium Brazil Canada Chile Colombia Finland France Germany Greece Israel Italy Japan Mexico Netherlands New Zealand Norway Portugal Romania Russia Singapore South Korea Spain Taiwan United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38155060 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31823654 (View on PubMed)

Related Links

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Other Identifiers

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2024-512158-12

Identifier Type: OTHER

Identifier Source: secondary_id

CA017-078

Identifier Type: -

Identifier Source: org_study_id

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