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)

August 25, 2025 updated by: Bristol-Myers Squibb

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Expanded Access

Expanded Access

A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Approved

Approved

  • Available: Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
  • No longer available: Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
  • Temporarily not available: Expanded access is not currently available for this intervention but is expected to be available in the future.
  • Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
 for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 2: Event Free Survival
Time Frame: Approximately 44 Months and 1 Week

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 2: Worsening-Free Survival
Time Frame: Approximately 44 months and 1 week

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
Time Frame: Approximately 44 months and 1 week

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
Time Frame: 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
Time Frame: Approximately 44 months and 1 week

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
Time Frame: 24.6 months

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
Time Frame: 24.6 months

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
Time Frame: 24.6 months

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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