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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04149574
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
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 9, 2019
Estimated Primary Completion Date : November 15, 2022
Estimated Study Completion Date : August 16, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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




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 ]


Information from the National Library of Medicine

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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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149574


Contacts
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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
Show Show 85 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04149574    
Other Study ID Numbers: CA209-7G8
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Nivolumab
BCG Vaccine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs