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

Not Applicable

Not yet recruiting

• Conditions: NMIBC; Non-Muscle Invasive Bladder Urothelial Carcinoma; Bladder (Urothelial, Transitional Cell) Cancer; Urothelial Carcinoma Bladder
• Interventions: Drug: Gemcitabine + BCG; Drug: BCG (TICE strain)

• Registration Number: NCT07064863
• Lead Sponsor: Queen's University

Brief Summary

This study is being conducted to establish a novel tumor tissue- and blood-based biomarker test to assess early systemic and local response to immunomodulation by BCG immunotherapy in patients with high-risk non-muscle invasive bladder cancer. Responses will be compared between patients with high-risk NMIBC who are being treated with standard of care BCG therapy and those treated with combination chemotherapy. Local and systemic immune monitoring assays will allow early identification of patients who will not benefit from BCG immunotherapy.

Detailed Description

BCG immunotherapy is the current gold standard for NMIBC. However, \~50% of patients will eventually experience recurrence or progression. Pre-treatment immune competence of the patient, the bladder microenvironment and systemic immune responses to immunomodulation by BCG govern effectiveness. The investigators intend to utilize a novel tumor tissue and blood based biomarker test to assess early systemic responses to standard of care BCG based immunotherapy as well as alternate strategies to enhance immune responses as measured systemically as well as based on early response rates (3 month complete response or 3 month recurrence). The goal of this study is to develop strategies to identify novel more effective anti-tumor immune responses for NMIBC.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-07
• Study First Submitted QC: 2025-07-07
• Last Update Submitted: 2025-07-14
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-17
• Study Start: 2025-08-01
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Patients with an initial diagnosis of NMIBC without previous exposure to BCG immunotherapy (BCG-naive).
• Patients with pathologic diagnosis of Ta or T1 high grade NMIBC with or without CIS.
• Participants older than 65 years of age.

Exclusion Criteria

• Patients with prior exposure to BCG immunotherapy.
• Immunosuppressed patients on steroids, transplants etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravesical Gemcitabine + BCG	Gemcitabine + BCG	Patients will be recruited to treatment with gemcitabine at week 0 following which BCG (50 mg, TICE strain) will be administered once every week for a total of 5 instillations.
Intravesical Bacillus Calmette-Guérin (BCG)	BCG (TICE strain)	6 intravesical instillations of BCG (50 mg, TICE strain) at weekly intervals.

Primary Outcome Measures

Name	Time	Method
BCG ImmunoScore	3 months	Complete response at 3 months with no evidence of tumor recurrence as assessed by biopsy. Demonstrable immunological responses measured at weeks 2, and 5 post-treatment, based on a novel tissue and blood based immune biomarker.

Secondary Outcome Measures

Name	Time	Method
Recurrence free survival	12 months	Recurrence free survival at 12 months post treatment initiation.

Trial Locations

Locations (1)

Kingston Health Sciences Center; 🇨🇦 Kingston, Ontario, Canada