Description:
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.
Title
- 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)
- 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
Clinical Trial IDs
- ORG STUDY ID:
CA209-7G8
- NCT ID:
NCT04149574
Conditions
Interventions
Drug | Synonyms | Arms |
---|
nivolumab | | Arm A: nivolumab |
Bacillus Calmette-Guérin (BCG) | | Arm A: nivolumab |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: nivolumab | Experimental | | - nivolumab
- Bacillus Calmette-Guérin (BCG)
|
Arm B: placebo +BCG | Placebo Comparator | | - Bacillus Calmette-Guérin (BCG)
|
Eligibility 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Event Free Survival (EFS) |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Worsening- Free Survival (WFS) |
Time Frame: | approximately 7 years |
Safety Issue: | |
Description: | |
Measure: | Overall Survival (OS) |
Time Frame: | approximately 10 years |
Safety Issue: | |
Description: | |
Measure: | Complete Response Rate (CRR) |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Duration of Response (DOR) |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Number of laboratory abnormalities |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Number of Laboratory changes from baseline |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of serious adverse Events (SAEs) |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of adverse events leading to discontinuation |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of immune-medicated adverse events (IMAEs) |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of Deaths |
Time Frame: | approximately 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
August 2, 2021