Phase 1/2 Study of Modern Immunotherapy in BCG-Relapsing Urothelial Carcinoma of the Bladder (ADAPT)

N
Nabil Adra, MD

Primary Investigator

Overview

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.

Description

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.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    bladder cancer,urothelial carcinoma of the bladder
  • Age: Between 18 Years - 100 Years
  • Gender: All

Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Histologically confirmed non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis stage) on TURBT obtained within 42 days of registration.
  • Age ≥ 18 years old at time of consent
For a full list of participation criteria, please visit clinicaltrials.gov.
Additional Information:
Participants will not be paid for their participation.

Updated on 09 Mar 2024. Study ID: 1805554463 (GU16-243)
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