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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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)

  • Clinicaltrials.gov identifier

    NCT04149574

  • Recruitment Status

    Recruiting

  • First Posted

    November 4, 2019

  • Last update posted

    August 2, 2021

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:Bladder Cancer
  • Intervention/Treatment: Drug: nivolumab
    Other: Placebo
    Biological: Bacillus Calmette-Guérin (BCG)
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 700 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • 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: December 2019
  • Estimated Primary Completion Date: November 2022
  • Estimated Study Completion Date: August 2030

Arms and interventions

Arm Intervention/treatment
Experimental: Arm A: nivolumab
Drug: nivolumab
Specified Dose on Specific Days

Biological: Bacillus Calmette-Guérin (BCG)
Intravesicular
Placebo Comparator: Arm B: placebo +BCG
Other: Placebo
Specified Dose on Specific Days

Biological: Bacillus Calmette-Guérin (BCG)
Intravesicular

Outcome Measures

  • Primary Outcome Measures: 1. Event Free Survival (EFS) [ Time Frame: approximately 3 years ]
  • Secondary Outcome Measures: 1. Worsening- Free Survival (WFS) [ Time Frame: approximately 7 years ]
  • 2. Overall Survival (OS) [ Time Frame: approximately 10 years ]
  • 3. Complete Response Rate (CRR) [ Time Frame: approximately 3 years ]
  • 4. Duration of Response (DOR) [ Time Frame: approximately 3 years ]
  • 5. Number of laboratory abnormalities [ Time Frame: approximately 3 years ]
  • 6. Number of Laboratory changes from baseline [ Time Frame: approximately 3 years ]
  • 7. Incidence of Adverse Events (AEs) [ Time Frame: approximately 3 years ]
  • 8. Incidence of serious adverse Events (SAEs) [ Time Frame: approximately 3 years ]
  • 9. Incidence of adverse events leading to discontinuation [ Time Frame: approximately 3 years ]
  • 10. Incidence of immune-medicated adverse events (IMAEs) [ Time Frame: approximately 3 years ]
  • 11. Incidence of Deaths [ Time Frame: approximately 3 years ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion: - Predominant histologic component (> 50%) must be urothelial (transitional cell) carcinoma - 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) - Sufficient tissue for both biomarker analysis and central pathology review committee (PRC) confirmation of diagnosis - Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 - Women of child bearing potential (WOCBP) and men with WOCBP partners must agree to follow contraceptive requirements 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 - Prior surgery (other than transurethral resection of the bladder tumor (TURBT)/biopsies) for bladder cancer; prior radiation therapy, or systemic chemotherapy or immunotherapy for bladder cancer or UC Other inclusion/exclusion criteria apply.

Contacts and Locations

Contacts

Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com

Contact: First line of the email MUST contain NCT # and Site #

Locations

Argentina
Local Institution
Caba

Argentina, Buenos Aires
Instituto Alexander Fleming
Caba

Argentina, Buenos Aires
Hospital Sirio Libanes
Capital Federal

Argentina, Buenos Aires
Cemic
Ciudad Autonoma Beunos Aires

Argentina, Buenos Aires
Local Institution
Mar Del Plata

Argentina, RIO Negro
Clinica Viedma S.A.
Viedma

Argentina
Local Institution
Buenos Aires

Argentina
Instituto Oncologico De Cordoba
Cordoba

United States, Arizona
Local Institution
Tucson

United States, Colorado
University Of Colorado Cancer Center
Aurora

United States, Connecticut
Local Institution
New Haven

United States, Delaware
Local Institution
Newark

United States, District of Columbia
Local Institution
Washington

United States, Idaho
Local Institution
Boise

United States, Illinois
The University Of Chicago
Chicago

United States, Maryland
Local Institution
Baltimore

United States, New York
Montefiore Medical Center - Bronx
Bronx

United States, Texas
Local Institution
Fort Worth

United States, Texas
Local Institution
Temple

United States, Washington
Local Institution
Seattle

United States, Washington
Local Institution
Tacoma

Australia, New South Wales
Local Institution
Kogarah

Australia, New South Wales
Local Institution
St Leonards

Australia, New South Wales
Local Institution
Sydney

Australia, Queensland
Local Institution
Woolloongabba

Australia
Local Institution
Bowral

Austria
Krankenhaus der Elisabethinen Linz GmbH
Linz

Austria
Universitatsklinikun Salzburg-Salzburger Landeskliniken
Salzburger

Austria
Klinikum Wels-Grieskirchen Gmbh
Wels

Austria
Medizinische Universitaet Wien
Wien

Brazil, Minas Gerais
Local Institution
Uberlandia

Brazil, RIO Grande DO SUL
Local Institution
Porto Alegre

Brazil, Santa Catarina
Local Institution
Itajai

Brazil
Local Institution
Rio de Janeiro

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Levis

Canada, Quebec
Local Institution
Montreal

Canada, Quebec
Local Institution
Montreal

Canada, Quebec
Local Institution
Rimouski

Chile, Coquimbo
IC La Serena Research
La Serena

Chile, Metropolitana
Bradfordhill
Recoleta

Chile, Valparaiso
Oncocentro Apys
Vina del Mar

China, Beijing
Local Institution
Beijing Shi

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Beijing
Local Institution
Beijing

China, Fujian
Local Institution
Ximen

China, Guangdong
Local Institution
Guangzhou

China, Guangdong
Local Institution
Guangzhou

China, Hunan
Local Institution
Changsha

China, Jiangsu
Local Institution
Nanjing

China, Jiangsu
Local Institution
Nanjng

China, Jiangxi
Local Institution
Nanchang

China, Shandong
Local Institution
Jinan

China, Shanghai
Local Institution
Shanghai

China, Shanghai
Local Institution
Shanghai

China, Sichuan
Local Institution
Chengdu

China, Sichuan
Local Institution
Chengdu

China, Tianjin
Local Institution
Tianjin

China, Zhejiang
Local Institution
Ningbo

China, Zhejiang
Local Institution
Zhejiang

France
Chu Angers
Angers Cedex 10

France
Local Institution
DIJON Cedex

France
Hopital Claude Huriez
Lille

France
Local Institution
Lyon Cedex 08

France
Hopital De La Conception
Marseille Cedex 05

France
Local Institution
Nice

France
Hopital Cochin
Paris Cedex 14

France
Hopital Bichat Claude Bernard
Paris Cedex 18

France
ICANS-Institut de cancerologie Strasbourg Europe
Strasbourg

France
Local Institution
Toulouse Cedex 9

France
Institut Gustave Roussy
Villejuif

Germany
Local Institution
Aachen

Germany
Marien Hospital Herne
Herne

Germany
Universitaetsklinikum Jena
Jena

Germany
Urologie Bayenthal
Koeln

Germany
Krankenhaus der Barmherzigen Brueder
Trier

Greece
University General Hospital of Athens Attikon
Haidari

Greece
Interbalkan European Medical Center
Thessaloniki

Ireland, Cork
Local Institution
Wilton

Ireland, Dublin
Local Institution
Tallaght

Israel
Local Institution
Haifa

Israel
Local Institution
Jerusalem

Israel
Local Institution
Ramat-gan

Israel
Local Institution
Tel Aviv

Italy, TO
Local Institution
Torino

Italy
Local Institution
Milano

Italy
Local Institution
Modena

Italy
Local Institution
Napoli

Italy
Local Institution
Reggio Emilia

Italy
Local Institution
Roma

Japan, Aichi
Local Institution
Nagakute-shi

Japan, Aomori
Local Institution
Hirosaki-shi

Japan, Hokkaido
Local Institution
Sapporo-city

Japan, Hyogo
Local Institution
Kobe-shi

Japan, Ibaraki
Local Institution
Tsukuba-shi

Japan, Kanagawa
Local Institution
Kawasaki-shi

Japan, Kanagawa
Local Institution
Yokohama City

Japan, Nagasaki
Local Institution
Nagasaki-shi

Japan, Nara
Local Institution
Kashihara-shi

Japan, Niigata
Local Institution
Niigata-shi

Japan, Okayama
Local Institution
Kurashiki-shi

Japan, Osaka
Local Institution
Hirakata

Japan, Osaka
Local Institution
Osakasayamashi

Japan, Osaka
Local Institution
Takatsuki-shi

Japan, Shizuoka
Local Institution
Hamamatsu-shi

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan, Tokyo
Local Institution
Shinjuku-Ku

Japan
Local Institution
Wakayama

Netherlands
Local Institution
Arnhem

Netherlands
Local Institution
Leeuwarden

Netherlands
Local Institution
Leiden

Netherlands
Local Institution
Rotterdam

Netherlands
Local Institution
Utrecht

Romania
Local Institution
Bucharest

Romania
Local Institution
Cluj-Napoca

Romania
Local Institution
Craiova

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Saint-Petersburg

Singapore
Local Institution
Singapore

Singapore
Local Institution
Singapore

Spain
Local Institution
Badajoz

Spain
Local Institution
Badalona-barcelona

Spain
Local Institution
Madrid

Spain
Local Institution
Malaga

Spain
Local Institution
Pamplona

Spain
Local Institution
Sabadell

Spain
Local Institution
Santander

Spain
Local Institution
València

Sweden
Local Institution
Norrkoping

Sweden
Local Institution
Umea

United Kingdom, Dumfries & Galloway
Local Institution
Glasgow

United Kingdom, Greater Manchester
Local Institution
Manchester

United Kingdom, Warwickshire
Local Institution
Coventry

United Kingdom
Local Institution
Bebington

United Kingdom
Local Institution
Bournemouth

United Kingdom
Local Institution
Guildford

United Kingdom
Local Institution
Manchester

United Kingdom
Local Institution
Sheffield

United Kingdom
Local Institution
Stoke-on-Trent

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT04149574 History of Changes
  • Other Study ID Numbers: CA209-7G8
  • First Posted: November 4, 2019 Key Record Dates
  • Last Update Posted: August 2, 2021
  • Last Verified: July 2021
  • 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