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Urinary Bladder NeoplasmsPhase 3CheckMate 7G8NCT04149574

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)

A Phase 3 study testing nivolumab and Bacillus Calmette-Guérin (BCG) in people with Urinary Bladder Neoplasms, run by Bristol-Myers Squibb at 63 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder Neoplasms
What is being tested?
nivolumab and Bacillus Calmette-Guérin (BCG)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
63 sitesin 16 countries
Study dates
15 Jan 2020to 31 Oct 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

63 sites in 16 countries.

63 sites in 16 countries

France8 sites

  • Local Institution - 0042

    Angers, 49933

  • Local Institution - 0106

    Dijon, 21079

  • Local Institution - 0045

    Lille, 59000

  • Local Institution - 0108

    Marseille, 13385

  • Local Institution - 0111

    Paris, 75018

  • Local Institution - 0103

    Paris, 75679

  • Local Institution - 0041

    Strasbourg, FR-67091

  • Local Institution - 0040

    Villejuif, 94800

Other trials in France

Argentina7 sites

  • Local Institution - 0080

    Buenos Aires, 1120

  • Local Institution - 0009

    Caba, Buenos Aires, 1426

  • Local Institution - 0088

    Capital Federal, Buenos Aires, 1419

  • Local Institution - 0016

    Ciudad Autonoma Beunos Aires, Buenos Aires, 1431

  • Local Institution - 0107

    Córdoba, 5000

  • Local Institution - 0081

    Mar del Plata, Buenos Aires, 7600

  • Local Institution - 0008

    Viedma, Río Negro Province, 8500

Other trials in Argentina

Spain7 sites

  • Local Institution - 0061

    Badajoz, 06006

  • Local Institution - 0060

    Badalona-barcelona, 08916

  • Local Institution - 0055

    Madrid, 28041

  • Local Institution - 0096

    Pamplona, Navarre, 31008

  • Local Institution - 0059

    Sabadell, 08208

  • Local Institution - 0057

    Santander, 39008

  • Local Institution - 0058

    Valencia, 46010

Other trials in Spain

Italy6 sites

  • Local Institution - 0062

    Milan, 20133

  • Local Institution - 0063

    Modena, 41124

  • Local Institution - 0064

    Naples, 80131

  • Local Institution - 0065

    Reggio Emilia, 42100

  • Local Institution - 0066

    Roma, 00168

  • Local Institution - 0067

    Torino, TO, 10126

Other trials in Italy

Austria4 sites

  • Local Institution - 0097

    Linz, 4010

  • Local Institution - 0104

    Salzburger, 5020

  • Local Institution - 0099

    Vienna, 1090

  • Local Institution - 0098

    Wels, 4600

Other trials in Austria

Brazil4 sites

  • Local Institution - 0047

    Itajaí, Santa Catarina, 88301-220

  • Local Institution - 0048

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Local Institution - 0049

    Rio de Janeiro, 22793-080

  • Local Institution - 0050

    Uberlândia, Minas Gerais, 38408-150

Other trials in Brazil

Canada4 sites

  • Local Institution - 0038

    Montreal, Quebec, H2X 0C2

  • Local Institution - 0037

    Montreal, Quebec, H3T 1E2

  • Local Institution - 0012

    Rimouski, Quebec, G5L 5T1

  • Local Institution - 0017

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

Germany4 sites

  • Local Institution - 0105

    Cologne, 50968

  • Local Institution - 0094

    Herne, 44625

  • Local Institution - 0093

    Jena, 07747

  • Local Institution - 0095

    Trier, 54292

Other trials in Germany

Australia3 sites

  • Local Institution - 0114

    Bowral, 2576

  • Local Institution - 0002

    Sydney, New South Wales, 2050

  • Local Institution - 0001

    Woolloongabba, Queensland, 4012

Other trials in Australia

Chile3 sites

  • Local Institution - 0011

    La Serena, Coquimbo Region, 1720430

  • Local Institution - 0010

    Recoleta, Santiago Metropolitan, 0

  • Local Institution - 0072

    Viña del Mar, Valparaiso, 2520598

Other trials in Chile

Israel3 sites

  • Local Institution - 0073

    Jerusalem, 9103102

  • Local Institution - 0074

    Ramat Gan, 52621

  • Local Institution - 0075

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

United States2 sites

  • The University Of Chicago

    Chicago, Illinois, 60637

  • Local Institution - 0084

    The Bronx, New York, 10461

Other trials in United States

Greece2 sites

  • Local Institution - 0031

    Haidari, 12462

  • Local Institution - 0032

    Thessaloniki, 57001

Other trials in Greece

Netherlands2 sites

  • Local Institution - 0054

    Arnhem, 6815 AD

  • Local Institution

    Rotterdam, 3015 GD

Other trials in Netherlands

Russia2 sites

  • Local Institution - 0051

    Moscow, 121309

  • Local Institution - 0052

    Saint Petersburg, 199034

Other trials in Russia

Sweden2 sites

  • Local Institution - 0087

    Norrköping, 601 82

  • Local Institution - 0083

    Umeå, 901 85

Other trials in Sweden

About this study

Official title: 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.

Being tested
nivolumab, Placebo, Bacillus Calmette-Guérin (BCG)
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nivolumabDrug

    Specified Dose on Specified Days

  • PlaceboOther

    Specified Dose on Specified Days

  • Bacillus Calmette-Guérin (BCG)Biological

    Specified Dose on Specified Days

Study groups in NCT04149574
Study groupRoleWhat they receive
Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)ExperimentalNot described
Receives: Drug: nivolumab; Biological: Bacillus Calmette-Guérin (BCG)
Arm B: placebo +BCGPlacebo comparatorNot described
Receives: Other: Placebo; Biological: Bacillus Calmette-Guérin (BCG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Approximately 44 Months and 1 Week

Secondary outcomes (7)

  1. 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)

    Measured: Approximately 44 months and 1 week

  2. 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)

    Measured: Approximately 44 months and 1 week

  3. 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)

    Measured: 13 Weeks

  4. 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)

    Measured: Approximately 44 months and 1 week

  5. 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.

    Measured: 24.6 months

  6. 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.

    Measured: 24.6 months

  7. 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.

    Measured: 24.6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start15 Jan 2020
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Why it stopped: Insufficient enrollment, inability to meet protocol objectives, and slow accrual.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04149574
Sponsor's protocol ID
CA209-7G8
Acronym
CheckMate 7G8
Status last verified
Aug 2025
First submitted
31 Oct 2019
Last updated
16 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing nivolumab and Bacillus Calmette-Guérin (BCG) in people with Urinary Bladder Neoplasms, run by Bristol-Myers Squibb at 63 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in France, Argentina, Spain, Italy, Austria and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 2: Event Free Survival (time frame: Approximately 44 Months and 1 Week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04149574.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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