OncoMatch/Clinical Trials/NCT03317158
Modern Immunotherapy in BCG-Unresponsive, BCG-Relapsing and High Risk BCG-Naive Non-Muscle Invasive Urothelial Carcinoma of the Bladder
Is NCT03317158 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments for urothelial carcinoma.
Treatment: Durvalumab (Cohort 1-3) · Bacillus Calmette-Guérin (BCG) · Gemcitabine · Docetaxel · Tremelimumab · Durvalumab (Cohort 4/5) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage TIS
Performance status
ECOG (WHO) 0–1
Prior therapy
Cannot have received: PD-1/PD-L1/CTLA-4 directed agents
Subjects who have received prior therapy with PD-1, PD-L1, or CTLA-4 directed agents.
Cannot have received: radiation therapy to prostate or pelvis
Exception: May be eligible for non-radiation containing regimens after consultation with study chair
Subjects who have had any prior radiation to the prostate or pelvis.
Cannot have received: intravesical gemcitabine and docetaxel (both) (gemcitabine, docetaxel)
Exception: Patients who have received either but not both remain eligible; if both, must be >24 months ago
Subjects who have received prior intravesical therapy with BOTH gemcitabine and docetaxel
Lab requirements
Blood counts
WBC > 3.0 K/mm3; ANC ≥ 1.5 K/mm3; Platelets ≥ 100 K/mm3; Hemoglobin (Hgb) ≥ 9 g/dL
Kidney function
Serum creatinine clearance (CrCl) ≥ 30 mL/min using the modified Cockcroft-Gault equation
Liver function
Serum total bilirubin: ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN
Adequate hematologic, hepatic, and renal function as defined by the following laboratory parameters
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- BCG Oncology · Phoenix, Arizona
- Stanford University · Stanford, California
- Rush University Medical Cneter · Chicago, Illinois
- Indiana University Melvin and Bren Simon Cancer Center · Indianapolis, Indiana
- University of Iowa Hospitals and Clinics · Iowa City, Iowa
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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