Phase 1/2 Study of Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder (ADAPT)
The main purpose of this phase 1 trial is to show that durvalumab is safe when given alone, in combination with BCG treatments, and in combination with radiation therapy. The overall goal of this trial is to see if the risk of your cancer coming back can be decreased with this treatment regimen.
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). In phase 2, BCG-relapsing 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.
Participants will not be paid for their participation.
- IRB Number: 1805554463 (GU16-243)
- Research Study Identifier: TX9021
- Principal Investigator: Nabil Adra, MD