A Study Comparing the Efficacy and Safety of Nivolumab in Combination With Bacillus Calmette-Guerin (BCG) Versus BCG Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC)

NCT04149574 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: CA209-7G8
• Study Type: interventional
• Target: 13
• Locations: 15 countries
• Sites: 59

Brief Summary

A study comparing nivolumab and bacterial drugs given to help the body's immune system in the bladder versus bacterial drugs alone in high risk bladder cancer participants.

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

• Part 2: Event Free Survival

  The time between the date of randomization and the date of first documented event or death due to any cause, whichever occurs first. Events include recurrence of disease (TaHG, T1, or CIS) and progression of disease. Data Not Collected (DNC)

  Approximately 44 Months and 1 Week

Secondary Outcomes (7)

• Part 2: Worsening-Free Survival

  Approximately 44 months and 1 week

• Part 2: Overall Survival

  Approximately 44 months and 1 week

• Part 2: Complete Response Rate at 13 Weeks

  13 Weeks

• Part 2: Duration of Response

  Approximately 44 months and 1 week

• All-causality Adverse Events Leading to Discontinuation

  24.6 months

Study Arms (2)

Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)

EXPERIMENTAL

Drug: nivolumab; Biological: Bacillus Calmette-Guérin (BCG)

Arm B: placebo +BCG

PLACEBO COMPARATOR

Other: Placebo; Biological: Bacillus Calmette-Guérin (BCG)

Interventions

nivolumab DRUG

Specified Dose on Specified Days

Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)

Placebo OTHER

Specified Dose on Specified Days

Arm B: placebo +BCG

Bacillus Calmette-Guérin (BCG) BIOLOGICAL

Specified Dose on Specified Days

Arm A: nivolumab + Bacillus Calmette-Guérin (BCG); Arm B: placebo +BCG

Eligibility Criteria

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

You may qualify if:

• Persistent or recurrent disease ≤ 24 months of last BCG dose, but not classified as BCG unresponsive
• Histologically confirmed persistent or recurrent high-risk non-muscle-invasive urothelial carcinoma (UC)
• Treated with at least 1 adequate course of induction BCG therapy (at least 5 out of 6 doses)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

You may not qualify if:

• Previous or concurrent muscle invasive, locally advanced, or disseminated/metastatic UC
• UC in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within 24 months of enrollment
• UC and/or CIS in the prostatic urethra within 12 months of enrollment

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (63)

The University Of Chicago

Chicago, Illinois, 60637, United States

Location

Local Institution - 0084

The Bronx, New York, 10461, United States

Location

Local Institution - 0009

Caba, Buenos Aires, 1426, Argentina

Location

Local Institution - 0088

Capital Federal, Buenos Aires, 1419, Argentina

Location

Local Institution - 0016

Ciudad Autonoma Beunos Aires, Buenos Aires, 1431, Argentina

Location

Local Institution - 0081

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Local Institution - 0008

Viedma, Río Negro Province, 8500, Argentina

Location

Local Institution - 0080

Buenos Aires, 1120, Argentina

Location

Local Institution - 0107

Córdoba, 5000, Argentina

Location

Local Institution - 0002

Sydney, New South Wales, 2050, Australia

Location

Local Institution - 0001

Woolloongabba, Queensland, 4012, Australia

Location

Local Institution - 0114

Bowral, 2576, Australia

Location

Local Institution - 0097

Linz, 4010, Austria

Location

Local Institution - 0104

Salzburger, 5020, Austria

Location

Local Institution - 0099

Vienna, 1090, Austria

Location

Local Institution - 0098

Wels, 4600, Austria

Location

Local Institution - 0050

Uberlândia, Minas Gerais, 38408-150, Brazil

Location

Local Institution - 0048

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

Location

Local Institution - 0047

Itajaí, Santa Catarina, 88301-220, Brazil

Location

Local Institution - 0049

Rio de Janeiro, 22793-080, Brazil

Location

Local Institution - 0017

Toronto, Ontario, M5G 1Z5, Canada

Location

Local Institution - 0038

Montreal, Quebec, H2X 0C2, Canada

Location

Local Institution - 0037

Montreal, Quebec, H3T 1E2, Canada

Location

Local Institution - 0012

Rimouski, Quebec, G5L 5T1, Canada

Location

Local Institution - 0011

La Serena, Coquimbo Region, 1720430, Chile

Location

Local Institution - 0072

Viña del Mar, Región de Valparaíso, 2520598, Chile

Location

Local Institution - 0010

Recoleta, Santiago Metropolitan, 0, Chile

Location

Local Institution - 0042

Angers, 49933, France

Location

Local Institution - 0106

Dijon, 21079, France

Location

Local Institution - 0045

Lille, 59000, France

Location

Local Institution - 0108

Marseille, 13385, France

Location

Local Institution - 0111

Paris, 75018, France

Location

Local Institution - 0103

Paris, 75679, France

Location

Local Institution - 0041

Strasbourg, FR-67091, France

Location

Local Institution - 0040

Villejuif, 94800, France

Location

Local Institution - 0105

Cologne, 50968, Germany

Location

Local Institution - 0094

Herne, 44625, Germany

Location

Local Institution - 0093

Jena, 07747, Germany

Location

Local Institution - 0095

Trier, 54292, Germany

Location

Local Institution - 0031

Haidari, 12462, Greece

Location

Local Institution - 0032

Thessaloniki, 57001, Greece

Location

Local Institution - 0075

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Local Institution - 0073

Jerusalem, 9103102, Israel

Location

Local Institution - 0074

Ramat Gan, 52621, Israel

Location

Local Institution - 0067

Torino, TO, 10126, Italy

Location

Local Institution - 0062

Milan, 20133, Italy

Location

Local Institution - 0063

Modena, 41124, Italy

Location

Local Institution - 0064

Napoli, 80131, Italy

Location

Local Institution - 0065

Reggio Emilia, 42100, Italy

Location

Local Institution - 0066

Roma, 00168, Italy

Location

Local Institution - 0054

Arnhem, 6815 AD, Netherlands

Location

Local Institution

Rotterdam, 3015 GD, Netherlands

Location

Local Institution - 0051

Moscow, 121309, Russia

Location

Local Institution - 0052

Saint Petersburg, 199034, Russia

Location

Local Institution - 0096

Pamplona, Navarre, 31008, Spain

Location

Local Institution - 0061

Badajoz, 06006, Spain

Location

Local Institution - 0060

Badalona-barcelona, 08916, Spain

Location

Local Institution - 0055

Madrid, 28041, Spain

Location

Local Institution - 0059

Sabadell, 08208, Spain

Location

Local Institution - 0057

Santander, 39008, Spain

Location

Local Institution - 0058

Valencia, 46010, Spain

Location

Local Institution - 0087

Norrköping, 601 82, Sweden

Location

Local Institution - 0083

Umeå, 901 85, Sweden

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Nivolumab

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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

1-855-907-3286

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: January 15, 2020
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: September 16, 2025
• Results First Posted: September 16, 2025

Record last verified: 2025-08

Locations

DE (4); IL (3); AR (7); NL (2); RU (2); FR (8); AU (3); GR (2); SE (2); IT (6); CA (4); ES (7); US (2); BR (4); CL (3)