Study Summary
This trial is for a treatment for bladder cancer. It will test different combinations of drugs, some with BCG and some without. If the side effects from a certain combination are too severe, that combination will not be used.
- Bladder Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 14 Secondary · Reporting Duration: 2 years (24 months)
Trial Safety
Safety Progress
Trial Design
10 Treatment Groups
Phase 2: (cohort 2a), (cohort 2b), & (BCG re-treatment)
1 of 10
Phase 1: (cohort 1):
1 of 10
Phase 1: Cohort 4
1 of 10
Phase 1: Cohort 6
1 of 10
Phase 2: Cohort 4 Expansion
1 of 10
Phase 1: Cohort 3
1 of 10
Phase 1: Cohort 2
1 of 10
Phase 1: Cohort 1
1 of 10
Phase 1: Cohort 5
1 of 10
Phase 1: (cohort 2a) & (cohort 2b):
1 of 10
Experimental Treatment
55 Total Participants · 10 Treatment Groups
Primary Treatment: Durvalumab · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
What positive results is this research hoping to achieve?
"This clinical trial, which is slated to run for 6 months or so, has two primary objectives. The first aims to identify the Recommended Phase 2 Dose from BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC). Additionally, associations between Complete Response Rate and 12 Month Relapse Free Survival Rates will be determined by analysing Baseline Tumor Immunohistochemistry Staining Patterns of PD-L1 as well as other pertinent Mechanisms of Action Targets. Lastly, the safety profile of NMIBC patients treated within each regimen studied will be assessed via NCI Common Terminology Criteria for" - Anonymous Online Contributor
Is enrollment still open in this research protocol?
"Affirmative. According to the information stored on clinicaltrials.gov, this medical trial is presently seeking participants; it was originally posted in November 2017 and most recently modified in October 2022. 186 individuals need to be recruited from 7 distinct medical centres." - Anonymous Online Contributor
How widespread is the implementation of this research project in our city?
"There are 7 trial sites recruiting participants. For example, UNC Chapel Hill in North Carolina, Indiana University's Melvin and Bren Simon Cancer Center in Indianapolis, the University of Iowa Hospitals & Clinics located in Iowa City - plus four other venues." - Anonymous Online Contributor
In what clinical scenarios is Durvalumab typically recommended?
"Durvalumab has been approved as a viable treatment for unresectable stage III non-small cell lung cancer, untreated metastatic urothelial carcinoma, and other conditions." - Anonymous Online Contributor
What is the cap on how many participants can join this clinical trial?
"Affirmative. According to clinicaltrials.gov, this study is actively enrolling participants across 7 sites since it was first made available on November 21st 2017 and recently updated October 31st 2022. At present, 186 individuals need to be enrolled in the trial overall." - Anonymous Online Contributor
Could you provide a synopsis of the past experiments done with Durvalumab?
"At present, 333 clinical trials are active for Durvalumab. Of these studies, 52 have progressed to Phase 3. There is a heavy concentration of research sites in Cordoba, Texas; however, the medication is being explored at numerous locations across 12952 cities and towns." - Anonymous Online Contributor