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)

April 18, 2024 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

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 3

Expanded Access

Approved 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
      • Cordoba, 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
    • RIO Negro
      • Viedma, RIO Negro, 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
      • Wels, Austria, 4600
        • Local Institution - 0098
      • Wien, Austria, 1090
        • Local Institution - 0099
  • Brazil
      • Rio de Janeiro, Brazil, 22793-080
        • Local Institution - 0049
    • Minas Gerais
      • Uberlandia, 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
      • Itajai, 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
      • La Serena, Coquimbo, Chile, 1720430
        • Local Institution - 0011
    • Metropolitana
      • Recoleta, Metropolitana, Chile
        • Local Institution - 0010
    • Valparaiso
      • Vina del Mar, Valparaiso, Chile, 2520598
        • Local Institution - 0072
  • France
      • Angers Cedex 10, France, 49933
        • Local Institution - 0042
      • DIJON Cedex, France, 21079
        • Local Institution - 0106
      • Lille, France, 59000
        • Local Institution - 0045
      • Marseille Cedex 05, France, 13385
        • Local Institution - 0108
      • Paris Cedex 14, France, 75679
        • Local Institution - 0103
      • Paris Cedex 18, France, 75018
        • Local Institution - 0111
      • Strasbourg, France, FR-67091
        • Local Institution - 0041
      • Villejuif, France, 94800
        • Local Institution - 0040
  • Germany
      • Herne, Germany, 44625
        • Local Institution - 0094
      • Jena, Germany, 07747
        • Local Institution - 0093
      • Koeln, Germany, 50968
        • Local Institution - 0105
      • 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
      • Milano, 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
  • Japan
      • Wakayama, Japan, 641-8509
        • Local Institution - 0145
    • Aichi
      • Nagakute-shi, Aichi, Japan, 4801195
        • Local Institution - 0147
    • Aomori
      • Hirosaki-shi, Aomori, Japan, 0368563
        • Local Institution - 0158
    • Hokkaido
      • Sapporo-city, Hokkaido, Japan, 0608543
        • Local Institution - 0161
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 6500047
        • Local Institution - 0155
    • Ibaraki
      • Tsukuba-shi, Ibaraki, Japan, 3058576
        • Local Institution - 0149
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 2168511
        • Local Institution - 0146
      • Yokohama City, Kanagawa, Japan, 2220036
        • Local Institution - 0153
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan, 8528501
        • Local Institution - 0164
    • Nara
      • Kashihara-shi, Nara, Japan, 6348522
        • Local Institution - 0151
    • Niigata
      • Niigata-shi, Niigata, Japan, 9518520
        • Local Institution - 0165
    • Okayama
      • Kurashiki-shi, Okayama, Japan, 7108602
        • Local Institution - 0156
    • Osaka
      • Hirakata, Osaka, Japan, 5731191
        • Local Institution - 0157
      • Osakasayamashi, Osaka, Japan, 5898511
        • Local Institution - 0154
      • Takatsuki-shi, Osaka, Japan, 5698686
        • Local Institution - 0160
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 4313192
        • Local Institution - 0159
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 1138603
        • Local Institution - 0162
      • Shinjuku-Ku, Tokyo, Japan, 1608582
        • Local Institution - 0150
  • Netherlands
      • Arnhem, Netherlands, 6815 AD
        • Local Institution - 0054
      • Rotterdam, Netherlands, 3015 GD
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 121309
        • Local Institution - 0051
      • Saint-Petersburg, Russian Federation, 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
      • València, Spain, 46010
        • Local Institution - 0058
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Local Institution - 0096
  • Sweden
      • Norrkoping, Sweden, 601 82
        • Local Institution - 0087
      • Umea, Sweden, 901 85
        • Local Institution - 0083
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago
    • New York
      • 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

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
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
Time Frame
Event Free Survival (EFS)
Time Frame: approximately 3 years
approximately 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Worsening- Free Survival (WFS)
Time Frame: approximately 3 years
approximately 3 years
Overall Survival (OS)
Time Frame: approximately 3 years
approximately 3 years
Complete Response Rate (CRR)
Time Frame: approximately 3 years
approximately 3 years
Duration of Response (DOR)
Time Frame: approximately 3 years
approximately 3 years
Number of participants with laboratory abnormalities
Time Frame: approximately 3 years
approximately 3 years
Number of participants with laboratory changes from baseline
Time Frame: approximately 3 years
approximately 3 years
Number of participants with Adverse Events (AEs)
Time Frame: approximately 3 years
approximately 3 years
Number of Deaths
Time Frame: approximately 3 years
approximately 3 years

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • 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)

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 (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

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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