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.
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)
Categories
Completion Date
Completion Date Type
Actual
Conditions
Urinary Bladder Neoplasms
Eligibility 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
* 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
Inclusion 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
inclusion/
* 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
inclusion/
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04149574
Org Class
Industry
Org Full Name
Bristol-Myers Squibb
Org Study Id
CA209-7G8
Overall Status
Terminated
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Measure
Event Free Survival (EFS)
Outcome Time Frame
approximately 3 years
Secondary Outcomes
Outcome Time Frame
approximately 3 years
Outcome Measure
Worsening- Free Survival (WFS)
Outcome Time Frame
approximately 3 years
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
approximately 3 years
Outcome Measure
Complete Response Rate (CRR)
Outcome Time Frame
approximately 3 years
Outcome Measure
Duration of Response (DOR)
Outcome Time Frame
approximately 3 years
Outcome Measure
Number of participants with laboratory abnormalities
Outcome Time Frame
approximately 3 years
Outcome Measure
Number of participants with laboratory changes from baseline
Outcome Time Frame
approximately 3 years
Outcome Measure
Number of participants with Adverse Events (AEs)
Outcome Time Frame
approximately 3 years
Outcome Measure
Number of Deaths
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Benjamin Gartrell
Investigator Email
bgartrel@montefiore.org
Investigator Phone
718-405-8404