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

Queen's University

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Urothelial Carcinoma Bladder; Non-Muscle Invasive Bladder Urothelial Carcinoma; NMIBC; Bladder (Urothelial, Transitional Cell) Cancer

Treatments: Drug: BCG (TICE strain); Drug: Gemcitabine + BCG

Study type: Interventional

Funder types: Other

Identifiers

NCT07064863

6043613

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Intravesical Gemcitabine + BCG

Experimental group

Description:

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.

Treatment:

Drug: Gemcitabine + BCG

Intravesical Bacillus Calmette-Guérin (BCG)

Active Comparator group

Description:

6 intravesical instillations of BCG (50 mg, TICE strain) at weekly intervals.

Treatment:

Drug: BCG (TICE strain)