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) (CheckMate 7G8)

A Phase 3, Randomized, Double-blind Trial of Nivolumab in Combination With Intravesical BCG Versus Standard of Care BCG Alone in Participants With High-risk Non-muscle Invasive Bladder Cancer That Is Persistent or Recurrent After Treatment With BCG

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Bladder Neoplasms
• Intervention / Treatment: Other: Placebo; Drug: nivolumab; Biological: Bacillus Calmette-Guérin (BCG)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1120
    • Local Institution - 0080
  • Córdoba, Argentina, 5000
    • Local Institution - 0107
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, 1426
      • Local Institution - 0009
    • Capital Federal, Buenos Aires, Argentina, 1419
      • Local Institution - 0088
    • Ciudad Autonoma Beunos Aires, Buenos Aires, Argentina, 1431
      • Local Institution - 0016
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Local Institution - 0081
  • Río Negro Province
    • Viedma, Río Negro Province, Argentina, 8500
      • Local Institution - 0008
• Australia
  • Bowral, Australia, 2576
    • Local Institution - 0114
  • New South Wales
    • Sydney, New South Wales, Australia, 2050
      • Local Institution - 0002
  • Queensland
    • Woolloongabba, Queensland, Australia, 4012
      • Local Institution - 0001
• Austria
  • Linz, Austria, 4010
    • Local Institution - 0097
  • Salzburger, Austria, 5020
    • Local Institution - 0104
  • Vienna, Austria, 1090
    • Local Institution - 0099
  • Wels, Austria, 4600
    • Local Institution - 0098
• Brazil
  • Rio de Janeiro, Brazil, 22793-080
    • Local Institution - 0049
  • Minas Gerais
    • Uberlândia, Minas Gerais, Brazil, 38408-150
      • Local Institution - 0050
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
      • Local Institution - 0048
  • Santa Catarina
    • Itajaí, Santa Catarina, Brazil, 88301-220
      • Local Institution - 0047
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1Z5
      • Local Institution - 0017
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C2
      • Local Institution - 0038
    • Montreal, Quebec, Canada, H3T 1E2
      • Local Institution - 0037
    • Rimouski, Quebec, Canada, G5L 5T1
      • Local Institution - 0012
• Chile
  • Coquimbo Region
    • La Serena, Coquimbo Region, Chile, 1720430
      • Local Institution - 0011
  • Región de Valparaíso
    • Viña del Mar, Región de Valparaíso, Chile, 2520598
      • Local Institution - 0072
  • Santiago Metropolitan
    • Recoleta, Santiago Metropolitan, Chile
      • Local Institution - 0010
• France
  • Angers, France, 49933
    • Local Institution - 0042
  • Dijon, France, 21079
    • Local Institution - 0106
  • Lille, France, 59000
    • Local Institution - 0045
  • Marseille, France, 13385
    • Local Institution - 0108
  • Paris, France, 75018
    • Local Institution - 0111
  • Paris, France, 75679
    • Local Institution - 0103
  • Strasbourg, France, FR-67091
    • Local Institution - 0041
  • Villejuif, France, 94800
    • Local Institution - 0040
• Germany
  • Cologne, Germany, 50968
    • Local Institution - 0105
  • Herne, Germany, 44625
    • Local Institution - 0094
  • Jena, Germany, 07747
    • Local Institution - 0093
  • Trier, Germany, 54292
    • Local Institution - 0095
• Greece
  • Haidari, Greece, 12462
    • Local Institution - 0031
  • Thessaloniki, Greece, 57001
    • Local Institution - 0032
• Israel
  • Jerusalem, Israel, 9103102
    • Local Institution - 0073
  • Ramat Gan, Israel, 52621
    • Local Institution - 0074
  • Tel Aviv
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Local Institution - 0075
• Italy
  • Milan, Italy, 20133
    • Local Institution - 0062
  • Modena, Italy, 41124
    • Local Institution - 0063
  • Napoli, Italy, 80131
    • Local Institution - 0064
  • Reggio Emilia, Italy, 42100
    • Local Institution - 0065
  • Roma, Italy, 00168
    • Local Institution - 0066
  • TO
    • Torino, TO, Italy, 10126
      • Local Institution - 0067
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Local Institution - 0054
  • Rotterdam, Netherlands, 3015 GD
    • Local Institution
• Russia
  • Moscow, Russia, 121309
    • Local Institution - 0051
  • Saint Petersburg, Russia, 199034
    • Local Institution - 0052
• Spain
  • Badajoz, Spain, 06006
    • Local Institution - 0061
  • Badalona-barcelona, Spain, 08916
    • Local Institution - 0060
  • Madrid, Spain, 28041
    • Local Institution - 0055
  • Sabadell, Spain, 08208
    • Local Institution - 0059
  • Santander, Spain, 39008
    • Local Institution - 0057
  • Valencia, Spain, 46010
    • Local Institution - 0058
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Local Institution - 0096
• Sweden
  • Norrköping, Sweden, 601 82
    • Local Institution - 0087
  • Umeå, Sweden, 901 85
    • Local Institution - 0083
• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
  • New York
    • The Bronx, New York, United States, 10461
      • Local Institution - 0084

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)	Drug: nivolumab; Specified Dose on Specified Days; Biological: Bacillus Calmette-Guérin (BCG); Specified Dose on Specified Days
Placebo Comparator: Arm B: placebo +BCG	Other: Placebo; Specified Dose on Specified Days; Biological: Bacillus Calmette-Guérin (BCG); Specified Dose on Specified Days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 2: Worsening-Free Survival	The time from randomization to progression to muscle-invasive disease (ie, T2), cystectomy, systemic chemotherapy, radiotherapy, or death from any cause. Data Not Collected (DNC)	Approximately 44 months and 1 week
Part 2: Overall Survival	The time between the date of randomization and the date of death due to any cause. For participants still alive, OS is censored at the last date the participant is known to be alive. Data Not Collected (DNC)	Approximately 44 months and 1 week
Part 2: Complete Response Rate at 13 Weeks	CRR is defined as the proportion of participants with CIS (+/- TaHG/T1) per PRC at randomization who are disease free at the first disease assessment (Week 13) Data Not Collected (DNC)	13 Weeks
Part 2: Duration of Response	the time between the date of the first CR to the date of first documented recurrence, progression, or death due to any cause. Data Not Collected (DNC)	Approximately 44 months and 1 week
All-causality Adverse Events Leading to Discontinuation	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria.	24.6 months
All-causality Adverse Events	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria.	24.6 months
Drug-related Adverse Events	An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be based on NCI CTCAE version 5.0 criteria.	24.6 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Substandard Drugs; Pharmaceutical Preparations; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; Counterfeit Drugs
• Other Study ID Numbers: CA209-7G8

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No