Actively Recruiting
Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Led by Noah Hahn, M.D. · Updated on 2026-04-15
55
Participants Needed
12
Research Sites
527 weeks
Total Duration
On this page
Sponsors
N
Noah Hahn, M.D.
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Upon successful screening and registration, enrollment to durvalumab monotherapy (cohort 1) will begin. If DLT criteria outlined in the protocol are exceeded with durvalumab monotherapy (cohort 1), the study will close. Provided the safety of durvalumab monotherapy is established, enrollment to combination regimen cohorts will proceed. Cohorts will simultaneously enroll in parallel to each other with patients assigned to cohorts based on patient slot availability and study site choice of radiation arm participation. Patient assignment to future phase 1 arms would proceed similarly. Within BCG-containing cohorts, treatment will begin at full-dose BCG. If DLT criteria outlined in Section 5.1.4 are exceeded with full-dose BCG, a one level dose reduction of BCG will be implemented. If DLT criteria outlined in Section 5.1.4 are exceeded with reduced-dose BCG, the BCG-containing cohort will not proceed to Phase 2 of the study. Similarly, if DLT criteria outlined in Section 5.1.4 are exceeded within non-BCG containing cohorts, the non-BCG containing cohort will not proceed to phase 2 of the study. Due to the prolonged half-life of antibody therapies, no dose adjustments are planned for durvalumab in any of the cohorts.
CONDITIONS
Official Title
Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed non-muscle invasive urothelial carcinoma of the bladder (Ta, T1, or Tis) on TURBT within 60 days of registration
- ECOG performance status 0 or 1
- Age 18 years or older at consent
- Adequate blood counts and organ function as defined by lab values
- Written informed consent according to local guidelines
- For Phase 1: BCG-unresponsive disease meeting specific criteria, including persistent/recurrent CIS or high-grade tumors within defined timeframes
- For Phase 1: Prostatic urethra involvement of NMIBC permitted
- For Phase 2: High-risk NMIBC defined by modified EORTC criteria, with at least half of subjects having CIS
- For Phase 2: Separate cohorts for BCG-unresponsive, BCG-relapsing/persistent, and high-risk BCG-naive NMIBC
- Patients with mixed histologies allowed if urothelial carcinoma component present
- Patients with prior non-muscle invasive tumors in prostatic urethra permitted in Phase 1 and 2
- Adequate BCG therapy as defined by at least 5 of 6 doses induction plus maintenance or second induction course
You will not qualify if you...
- Muscle-invasive (T2 or greater), locally advanced unresectable, or metastatic urothelial carcinoma
- Another active second malignancy except non-melanoma skin cancer and low-risk biochemical relapsed prostate cancer
- Recent anti-cancer therapy within 4 weeks or unresolved side effects from prior therapy
- Unresolved toxicity grade 2 or higher from prior cancer treatment (with some exceptions)
- Prior therapy with PD-1, PD-L1, or CTLA-4 agents
- Prior radiation to prostate or pelvis for radiation-containing regimens
- Recent major surgery or significant injury within 4 weeks or minor procedures within 1 week before study drug
- Severe uncontrolled medical conditions including significant cardiac diseases, cirrhosis, active infections (e.g., active tuberculosis, hepatitis B with positive surface antigen, active hepatitis C, known HIV infection)
- Active or prior autoimmune or inflammatory disorders with some exceptions
- Use of immunosuppressive medication within 14 days before first dose with some exceptions
- Pregnant or breastfeeding women; women of child-bearing potential must have negative pregnancy test and use contraception
- Fertile males unwilling to use contraception
- Unwilling or unable to comply with protocol
- Receipt of live attenuated vaccine within 30 days prior to first dose
- Known allergy or hypersensitivity to study drugs or excipients
- For Cohorts 4 and 5: prior intravesical therapy with both gemcitabine and docetaxel
- For Phase 2: concurrent high-grade upper urinary tract urothelial carcinoma (ureter, renal pelvis)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
BCG Oncology
Phoenix, Arizona, United States, 85032
Terminated
2
Stanford University
Stanford, California, United States, 94305
Withdrawn
3
Rush University Medical Cneter
Chicago, Illinois, United States, 60612
Withdrawn
4
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
6
Johns Hopkins University: Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231
Actively Recruiting
7
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Withdrawn
8
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
9
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
10
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
11
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Active, Not Recruiting
12
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
N
Noah Hahn, MD
CONTACT
L
LeaEtta Hyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
7
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