A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
Status:
Unknown status
Trial end date:
2018-03-01
Target enrollment:
Participant gender:
Summary
This is a Phase Ib/II, open-label, multi-center and competitive enrollment study of ALT-801
combined with gemcitabine for patients who have BCG failure (defined as refractory, relapsing
or intolerant), non-muscle invasive bladder cancer and refuse or are not medically fit to
undergo a radical cystectomy recommended by the participating urologist as the standard next
therapy per urologic guidelines. The purpose of this study is to confirm the safety and
tolerability of a well-tolerated dose level of ALT-801, to determine the Recommended Dose
level (RD) and characterize the immunogenicity of ALT-801 combined with gemcitabine in
treated patients. The anti-tumor responses will also be assessed.