Bladder cancer
Conditions
Interventions
The medical interventions include treatment with nivolumab, nivolumab-placebo
and BCG. Nivolumab will be supplied by the sponsor but not placebo nor BCG.
Patients will be randomly assigned to one of
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To compare the EFS per PRC of nivolumab plus BCG vs BCG alone in all randomized participants. EFS, defined as the time from randomization until any of the following events: recurrence (TaHG, T1 or CIS) or progression of disease, or death from any cause. For participants with CIS (+/- papillary disease) at study entry, a lack of complete response of the CIS component at the 13-week assessment will be considered an event. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the WFS of nivolumab plus BCG vs BCG alone in all randomized participants WFS, defined as the time from randomization to progression to muscle invasive disease, cystectomy,systemic chemotherapy, radiotherapy, or death from any cause. 2. To compare the OS of nivolumab plus BCG vs BCG alone in all randomized participants OS, defined as the time from randomization to death from any cause. 3. To evaluate the CRR at first disease assessment (Week 13) in all randomized participants with CIS (+/- papillary disease) at study entry by treatment arm (nivolumab plus BCG and BCG alone) CRR, defined as the proportion of participants with CIS (+/- papillary disease) at study entry who are disease free at the first disease assessment. 4. To evaluate the duration of response (DoR) in all randomized participants with CIS (+/- papillary disease) at study entry who achieved CRR at first disease assessment by treatment arm (nivolumab plus BCG and BCG alone) DoR is restricted to participants with CIS (+/- papillary disease) at study entry who are disease free at the first disease assessment and is defined as the time between the date of the first CR to the date of first documented recurrence, progression, or death due to any cause. 5. To describe the safety and tolerability of nivolumab plus BCG and BCG alone in all treated participants Overall safety and tolerability will be measured by the incidence of AEs, SAEs, AEs leading to discontinuation, IMAEs, deaths, and laboratory abnormalities and changes from baseline. | — |
Countries
Netherlands
Outcome results
None listed