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

Phase 3

Completed

Conditions: Bladder cancer
10038364

Registration Number: NL-OMON50043

Lead Sponsor: Bristol-Myers Squibb

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

_Signed Written Informed Consent;
_Histologically confirmed persistent or recurrent high-risk non-muscle-invasive
UC (TaHG and/or T1 and/or CIS);
_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;
_Males and females, ages 18 or age of majority, and older;

Exclusion Criteria

_Prior malignancy active within the previous 3 years except for locally curable
cancers that have been apparently cured or not requiring treatment;
_Patients with serious or uncontrolled medical disorders;
_Participants with an active, known, or suspected autoimmune disease;
_Recurrent high-risk NMIBC that is classified as BCG unresponsive;
_Has any contraindication to intravesical BCG therapy, including evidence of
active tuberculosis;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* To compare the EFS per PRC of nivolumab plus BCG vs BCG alone in all<br /><br>randomized participants.<br /><br><br /><br>EFS, defined as the time from randomization until any of the following events:<br /><br>recurrence (TaHG, T1 or CIS) or progression of disease, or death from any<br /><br>cause. For participants with CIS (+/- papillary disease) at study entry, a lack<br /><br>of complete response of the CIS component at the 13-week assessment will be<br /><br>considered an event.</p><br>

Secondary Outcome Measures