ADAPT-BLADDER: Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder

Summary

Participation Requirements

Description

Patient Assignment in Phase 1 Prior to commencing accrual, each study site will be required to self-identify their site as a site with (EBRT+) or without (EBRT-) the capacity to provide radiation therapy as specified in the durvalumab + EBRT arm. The radiation therapy status of each site will remain...

Patient Assignment in Phase 1 Prior to commencing accrual, each study site will be required to self-identify their site as a site with (EBRT+) or without (EBRT-) the capacity to provide radiation therapy as specified in the durvalumab + EBRT arm. The radiation therapy status of each site will remain fixed throughout the course of the trial. In phase 1 of the protocol, patients will be assigned to study treatment cohorts based on patient slot availability and study site choice of radiation therapy arm participation. Patient Randomization in Phase 2 In phase 2 of the protocol, subjects registered at self-identified EBRT+ study sites will be randomized 1:1 between all actively accruing study arms while subjects registered at self-identified EBRT- study sites will be randomized 1:1 between all actively accruing study arms except the durvalumab + EBRT arm. Papillary Subgroup Enrollment Cap As described further in the Section 12 enrollment in Phase 2 of patients with papillary only (Ta or T1) tumors with no evidence of concurrent CIS within each experimental study arm will be capped to ensure adequate representation of patients with CIS for planned efficacy analyses.

Tracking Information