Study of 2141-V11 in People With Non-muscle Invasive Bladder Cancer That Did Not Respond to Standard Treatment

Must have received: BCG therapy

unresponsive to adequate BCG therapy

Cannot have received: concurrent anti-cancer therapy

Exception: topical therapy (e.g. topical 5-fluorouracil) and neoadjuvant chemotherapy (e.g. cisplatin and gemcitabine) allowed in Cohort C; topical therapy allowed in Cohorts A and B

Concurrent anti-cancer therapy, including investigational agents [excluded]. Exceptions include: Cohorts A and B: topical therapy; Cohort C: topical therapy and neoadjuvant chemotherapy

Cannot have received: intravesical chemotherapy or immunotherapy

Exception: single dose of intravesical treatment given as part of the most recent cystoscopy/TURBT during screening is acceptable

Has undergone any intervening intravesical chemotherapy or immunotherapy from the time of most recent cystoscopy/TURBT to starting trial treatment

Cannot have received: chemotherapy, targeted small molecule therapy, cytokine therapy, or radiation therapy

Exception: Grade ≤2 neuropathy or Grade ≤2 alopecia are an exception

Has had prior chemotherapy, targeted small molecule therapy, cytokine therapy, or radiation therapy within 2 weeks prior to the first dose of trial treatment or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent