NCT07064863View on ClinicalTrials.gov

A Tumor Immune Biomarker Guided Approach for Improving Response to BCG in Patients With High-risk NMIBC.

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

August 1, 2025

Primary Completion Date

July 31, 2027

Study Completion Date

July 31, 2027

Conditions
NMIBCNon-Muscle Invasive Bladder Urothelial CarcinomaBladder (Urothelial, Transitional Cell) CancerUrothelial Carcinoma Bladder
Interventions
DRUG

Gemcitabine + BCG

Patients will receive a single intravesical instillation of gemcitabine (2000 mg) at week 0 followed by weekly BCG (50 mg of TICE strain) for a total of 5 instillations. Biopsy will be conducted within three months of completing the induction phase.

DRUG

BCG (TICE strain)

Patients will receive intravesical BCG (50 mg, TICE strain) at weekly intervals for a total of 6 instillations. Biopsy will be performed within 3 months of completing the induction phase.

Trial Locations (1)

K7L3N6

Kingston Health Sciences Center, Kingston

All Listed Sponsors
collaborator

Queen's University, Kingston, Ontario

OTHER

lead

Queen's University

OTHER