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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)

Primary Purpose

Urinary Bladder Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
nivolumab
Placebo
Bacillus Calmette-Guérin (BCG)
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University Of Chicago
  • Local Institution - 0084
  • Local Institution - 0009
  • Local Institution - 0088
  • Local Institution - 0016
  • Local Institution - 0081
  • Local Institution - 0008
  • Local Institution - 0080
  • Local Institution - 0107
  • Local Institution - 0002
  • Local Institution - 0001
  • Local Institution - 0114
  • Local Institution - 0097
  • Local Institution - 0104
  • Local Institution - 0098
  • Local Institution - 0099
  • Local Institution - 0050
  • Local Institution - 0048
  • Local Institution - 0047
  • Local Institution - 0049
  • Local Institution - 0017
  • Local Institution - 0038
  • Local Institution - 0037
  • Local Institution - 0012
  • Local Institution - 0011
  • Local Institution - 0010
  • Local Institution - 0072
  • Local Institution - 0042
  • Local Institution - 0106
  • Local Institution - 0045
  • Local Institution - 0108
  • Local Institution - 0103
  • Local Institution - 0111
  • Local Institution - 0041
  • Local Institution - 0040
  • Local Institution - 0094
  • Local Institution - 0093
  • Local Institution - 0105
  • Local Institution - 0095
  • Local Institution - 0031
  • Local Institution - 0032
  • Local Institution - 0075
  • Local Institution - 0073
  • Local Institution - 0074
  • Local Institution - 0067
  • Local Institution - 0062
  • Local Institution - 0063
  • Local Institution - 0064
  • Local Institution - 0065
  • Local Institution - 0066
  • Local Institution - 0147
  • Local Institution - 0158
  • Local Institution - 0161
  • Local Institution - 0155
  • Local Institution - 0149
  • Local Institution - 0146
  • Local Institution - 0153
  • Local Institution - 0164
  • Local Institution - 0151
  • Local Institution - 0165
  • Local Institution - 0156
  • Local Institution - 0157
  • Local Institution - 0154
  • Local Institution - 0160
  • Local Institution - 0159
  • Local Institution - 0162
  • Local Institution - 0150
  • Local Institution - 0145
  • Local Institution - 0054
  • Local Institution
  • Local Institution - 0051
  • Local Institution - 0052
  • Local Institution - 0096
  • Local Institution - 0061
  • Local Institution - 0060
  • Local Institution - 0055
  • Local Institution - 0059
  • Local Institution - 0057
  • Local Institution - 0058
  • Local Institution - 0087
  • Local Institution - 0083

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Arm B: placebo +BCG

Arm Description

Outcomes

Primary Outcome Measures

Event Free Survival (EFS)

Secondary Outcome Measures

Worsening- Free Survival (WFS)
Overall Survival (OS)
Complete Response Rate (CRR)
Duration of Response (DOR)
Number of participants with laboratory abnormalities
Number of participants with laboratory changes from baseline
Number of participants with Adverse Events (AEs)
Number of Deaths

Full Information

First Posted
October 31, 2019
Last Updated
October 11, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04149574
Brief Title
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)
Acronym
CheckMate 7G8
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
October 19, 2023 (Anticipated)
Study Completion Date
October 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: nivolumab + Bacillus Calmette-Guérin (BCG)
Arm Type
Experimental
Arm Title
Arm B: placebo +BCG
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
nivolumab
Intervention Description
Specified Dose on Specified Days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified Dose on Specified Days
Intervention Type
Biological
Intervention Name(s)
Bacillus Calmette-Guérin (BCG)
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Event Free Survival (EFS)
Time Frame
approximately 3 years
Secondary Outcome Measure Information:
Title
Worsening- Free Survival (WFS)
Time Frame
approximately 3 years
Title
Overall Survival (OS)
Time Frame
approximately 3 years
Title
Complete Response Rate (CRR)
Time Frame
approximately 3 years
Title
Duration of Response (DOR)
Time Frame
approximately 3 years
Title
Number of participants with laboratory abnormalities
Time Frame
approximately 3 years
Title
Number of participants with laboratory changes from baseline
Time Frame
approximately 3 years
Title
Number of participants with Adverse Events (AEs)
Time Frame
approximately 3 years
Title
Number of Deaths
Time Frame
approximately 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
The University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Local Institution - 0084
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Local Institution - 0009
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0088
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1419
Country
Argentina
Facility Name
Local Institution - 0016
City
Ciudad Autonoma Beunos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Local Institution - 0081
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Local Institution - 0008
City
Viedma
State/Province
RIO Negro
ZIP/Postal Code
8500
Country
Argentina
Facility Name
Local Institution - 0080
City
Buenos Aires
ZIP/Postal Code
1120
Country
Argentina
Facility Name
Local Institution - 0107
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0002
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution - 0001
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4012
Country
Australia
Facility Name
Local Institution - 0114
City
Bowral
ZIP/Postal Code
2576
Country
Australia
Facility Name
Local Institution - 0097
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Local Institution - 0104
City
Salzburger
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution - 0098
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
Local Institution - 0099
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0050
City
Uberlandia
State/Province
Minas Gerais
ZIP/Postal Code
38408-150
Country
Brazil
Facility Name
Local Institution - 0048
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-001
Country
Brazil
Facility Name
Local Institution - 0047
City
Itajai
State/Province
Santa Catarina
ZIP/Postal Code
88301-220
Country
Brazil
Facility Name
Local Institution - 0049
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Local Institution - 0017
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
Local Institution - 0038
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C2
Country
Canada
Facility Name
Local Institution - 0037
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution - 0012
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Local Institution - 0011
City
La Serena
State/Province
Coquimbo
ZIP/Postal Code
1720430
Country
Chile
Facility Name
Local Institution - 0010
City
Recoleta
State/Province
Metropolitana
ZIP/Postal Code
0
Country
Chile
Facility Name
Local Institution - 0072
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2520598
Country
Chile
Facility Name
Local Institution - 0042
City
Angers Cedex 10
ZIP/Postal Code
49933
Country
France
Facility Name
Local Institution - 0106
City
DIJON Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Local Institution - 0045
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Local Institution - 0108
City
Marseille Cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution - 0103
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Local Institution - 0111
City
Paris Cedex 18
ZIP/Postal Code
75018
Country
France
Facility Name
Local Institution - 0041
City
Strasbourg
ZIP/Postal Code
FR-67091
Country
France
Facility Name
Local Institution - 0040
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
Local Institution - 0094
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Local Institution - 0093
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Local Institution - 0105
City
Koeln
ZIP/Postal Code
50968
Country
Germany
Facility Name
Local Institution - 0095
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Local Institution - 0031
City
Haidari
ZIP/Postal Code
12462
Country
Greece
Facility Name
Local Institution - 0032
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
Local Institution - 0075
City
Tel Aviv
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Local Institution - 0073
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Local Institution - 0074
City
Ramat-gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution - 0067
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution - 0062
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution - 0063
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Local Institution - 0064
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution - 0065
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Local Institution - 0066
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution - 0147
City
Nagakute-shi
State/Province
Aichi
ZIP/Postal Code
4801195
Country
Japan
Facility Name
Local Institution - 0158
City
Hirosaki-shi
State/Province
Aomori
ZIP/Postal Code
0368563
Country
Japan
Facility Name
Local Institution - 0161
City
Sapporo-city
State/Province
Hokkaido
ZIP/Postal Code
0608543
Country
Japan
Facility Name
Local Institution - 0155
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution - 0149
City
Tsukuba-shi
State/Province
Ibaraki
ZIP/Postal Code
3058576
Country
Japan
Facility Name
Local Institution - 0146
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
2168511
Country
Japan
Facility Name
Local Institution - 0153
City
Yokohama City
State/Province
Kanagawa
ZIP/Postal Code
2220036
Country
Japan
Facility Name
Local Institution - 0164
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
8528501
Country
Japan
Facility Name
Local Institution - 0151
City
Kashihara-shi
State/Province
Nara
ZIP/Postal Code
6348522
Country
Japan
Facility Name
Local Institution - 0165
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
9518520
Country
Japan
Facility Name
Local Institution - 0156
City
Kurashiki-shi
State/Province
Okayama
ZIP/Postal Code
7108602
Country
Japan
Facility Name
Local Institution - 0157
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
5731191
Country
Japan
Facility Name
Local Institution - 0154
City
Osakasayamashi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Local Institution - 0160
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
5698686
Country
Japan
Facility Name
Local Institution - 0159
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
4313192
Country
Japan
Facility Name
Local Institution - 0162
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138603
Country
Japan
Facility Name
Local Institution - 0150
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Local Institution - 0145
City
Wakayama
ZIP/Postal Code
641-8509
Country
Japan
Facility Name
Local Institution - 0054
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Local Institution - 0051
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Local Institution - 0052
City
Saint-Petersburg
ZIP/Postal Code
199034
Country
Russian Federation
Facility Name
Local Institution - 0096
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Local Institution - 0061
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Facility Name
Local Institution - 0060
City
Badalona-barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution - 0055
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0059
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Local Institution - 0057
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 0058
City
València
ZIP/Postal Code
46010
Country
Spain
Facility Name
Local Institution - 0087
City
Norrkoping
ZIP/Postal Code
601 82
Country
Sweden
Facility Name
Local Institution - 0083
City
Umea
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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)

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