CheckMate 7G8: 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)

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04149574
• Collaborator: (none)
• Enrollment: 13
• Locations: 68
• Arms: 2
• Anticipated Duration (Months): 57.7
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Neoplasms	Drug: nivolumab; Other: Placebo; Biological: Bacillus Calmette-Guérin (BCG)	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 15, 2020
• Anticipated Primary Completion Date: Oct 19, 2023
• Anticipated Study Completion Date: Nov 4, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Event Free Survival (EFS) [approximately 3 years]

Secondary Outcome Measures

1. Worsening- Free Survival (WFS) [approximately 3 years]

2. Overall Survival (OS) [approximately 3 years]

3. Complete Response Rate (CRR) [approximately 3 years]

4. Duration of Response (DOR) [approximately 3 years]

5. Number of participants with laboratory abnormalities [approximately 3 years]

6. Number of participants with laboratory changes from baseline [approximately 3 years]

7. Number of participants with Adverse Events (AEs) [approximately 3 years]

8. Number of Deaths [approximately 3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Colorado Cancer Center	Aurora	Colorado	United States	80045
2	The University Of Chicago	Chicago	Illinois	United States	60637
3	Local Institution - 0084	Bronx	New York	United States	10461
4	Local Institution - 0009	Caba	Buenos Aires	Argentina	1426
5	Local Institution - 0088	Capital Federal	Buenos Aires	Argentina	1419
6	Local Institution - 0016	Ciudad Autonoma Beunos Aires	Buenos Aires	Argentina	1431
7	Local Institution	Mar Del Plata	Buenos Aires	Argentina	7600
8	Clinica Viedma S.A.	Viedma	RIO Negro	Argentina	8500
9	Local Institution - 0080	Buenos Aires		Argentina	1120
10	Instituto Oncologico De Cordoba	Cordoba		Argentina	5000
11	Local Institution - 0002	Sydney	New South Wales	Australia	2050
12	Local Institution - 0001	Woolloongabba	Queensland	Australia	4012
13	Local Institution	Bowral		Australia	2576
14	Krankenhaus der Elisabethinen Linz GmbH	Linz		Austria	4010
15	Universitatsklinikun Salzburg-Salzburger Landeskliniken	Salzburger		Austria	5020
16	Klinikum Wels-Grieskirchen Gmbh	Wels		Austria	4600
17	Medizinische Universitaet Wien	Wien		Austria	1090
18	Local Institution	Uberlandia	Minas Gerais	Brazil	38408-150
19	Local Institution - 0048	Porto Alegre	RIO Grande DO SUL	Brazil	90035-000
20	Local Institution	Itajai	Santa Catarina	Brazil	88301-220
21	Local Institution	Rio de Janeiro		Brazil	22793-080
22	Local Institution	Toronto	Ontario	Canada	M5G 1Z5
23	Local Institution	Montreal	Quebec	Canada	H2X 0C2
24	Local Institution	Montreal	Quebec	Canada	H3T 1E2
25	Local Institution - 0012	Rimouski	Quebec	Canada	G5L 5T1
26	Local Institution - 0011	La Serena	Coquimbo	Chile	1720430
27	Bradfordhill	Recoleta	Metropolitana	Chile
28	Oncocentro Apys	Vina del Mar	Valparaiso	Chile	2520598
29	Local Institution - 0117	Beijing	Beijing	China	100142
30	Local Institution - 0120	Changsha	Hunan	China	410013
31	Local Institution - 0129	Zhejiang	Zhejiang	China	310022
32	Chu Angers	Angers Cedex 10		France	49933
33	Local Institution - 0106	DIJON Cedex		France	21079
34	Local Institution - 0045	Lille		France	59000
35	Hopital De La Conception	Marseille Cedex 05		France	13385
36	Hopital Cochin	Paris Cedex 14		France	75679
37	Local Institution - 0111	Paris Cedex 18		France	75018
38	Local Institution - 0041	Strasbourg		France	FR-67091
39	Institut Gustave Roussy	Villejuif		France	94800
40	Local Institution - 0094	Herne		Germany	44625
41	Universitaetsklinikum Jena	Jena		Germany	07747
42	Urologie Bayenthal	Koeln		Germany	50968
43	Local Institution - 0095	Trier		Germany	54292
44	Local Institution - 0031	Haidari		Greece	12462
45	Local Institution - 0032	Thessaloniki		Greece	57001
46	Local Institution - 0075	Tel Aviv	Tel-Aviv	Israel	6423906
47	Local Institution - 0073	Jerusalem		Israel	9103102
48	Local Institution - 0074	Ramat-gan		Israel	52621
49	Local Institution - 0067	Torino	TO	Italy	10126
50	Local Institution - 0062	Milano		Italy	20133
51	Local Institution - 0063	Modena		Italy	41124
52	Local Institution - 0064	Napoli		Italy	80131
53	Local Institution - 0065	Reggio Emilia		Italy	42100
54	Local Institution - 0066	Roma		Italy	00168
55	Local Institution - 0161	Sapporo-city	Hokkaido	Japan	0608543
56	Local Institution	Arnhem		Netherlands	6815 AD
57	Local Institution	Rotterdam		Netherlands	3015 GD
58	Local Institution	Moscow		Russian Federation	121309
59	Local Institution - 0052	Saint-Petersburg		Russian Federation	199034
60	Local Institution - 0096	Pamplona	Navarra	Spain	31008
61	Local Institution	Badajoz		Spain	06006
62	Local Institution - 0060	Badalona-barcelona		Spain	08916
63	Local Institution - 0055	Madrid		Spain	28041
64	Local Institution - 0059	Sabadell		Spain	08208
65	Local Institution	Santander		Spain	39008
66	Local Institution	València		Spain	46010
67	Local Institution	Norrkoping		Sweden	601 82
68	Local Institution	Umea		Sweden	901 85

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls
• Investigator Inquiry Form

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04149574
• Other Study ID Numbers: CA209-7G8
• First Posted: Nov 4, 2019
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Bladder Neoplasms; Nivolumab; BCG Vaccine

Study Results

No Results Posted as of Jul 19, 2022