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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)

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ClinicalTrials.gov Identifier: NCT04149574
Recruitment Status : Active, not recruiting
First Posted : November 4, 2019
Last Update Posted : September 1, 2022
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
Urinary Bladder Neoplasms Drug: nivolumab Other: Placebo Biological: Bacillus Calmette-Guérin (BCG) Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
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 : January 15, 2020
Estimated Primary Completion Date : October 19, 2023
Estimated Study Completion Date : October 27, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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




Primary Outcome Measures :
  1. Event Free Survival (EFS) [ Time Frame: approximately 3 years ]

Secondary Outcome Measures :
  1. Worsening- Free Survival (WFS) [ Time Frame: approximately 3 years ]
  2. Overall Survival (OS) [ Time Frame: approximately 3 years ]
  3. Complete Response Rate (CRR) [ Time Frame: approximately 3 years ]
  4. Duration of Response (DOR) [ Time Frame: approximately 3 years ]
  5. Number of participants with laboratory abnormalities [ Time Frame: approximately 3 years ]
  6. Number of participants with laboratory changes from baseline [ Time Frame: approximately 3 years ]
  7. Number of participants with Adverse Events (AEs) [ Time Frame: approximately 3 years ]
  8. Number 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

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


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


Locations
Show Show 68 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 1, 2022
Last Verified: August 2022

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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
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs