ADAPT-BLADDER: Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
A multi-arm multi-stage (MAMS) phase 1/2 study. Phase 1 will be conducted in BCG-unresponsive
NMIBC patients to establish the safety of durvalumab monotherapy (cohort 1) and durvalumab in
combination with BCG (cohort 2a) and external beam radiation therapy (EBRT) (cohort 2b).
Provided safety is demonstrated and recommended phase 2 doses (RP2D) are established in phase
1, the study will proceed to phase 2 testing. Phase 2 will be conducted in the BCG-relapsing
or persistent NMIBC population. In phase 2, BCG-relapsing or persistent NMIBC subjects will
be randomized between treatment arms examining intravesical BCG in combination with novel
immunotherapy agents (durvalumab), novel immunotherapy in combination with radiation
(durvalumab + EBRT), or retreatment with intravesical BCG. In addition to providing
additional safety data on the combination regimens studied, phase 2 will provide preliminary
efficacy profiles for BCG-relapsing or persistent NMIBC subjects with and without CIS treated
with each regimen. For regimens demonstrating a tolerable safety profile and encouraging
clinical activity in this phase 1/2 design, a randomized phase 3 trial of experimental arm
therapy versus re-treatment with intravesical BCG therapy would be considered.