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

NCT07064863 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 6043613
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

BCG; NMIBC; Gemcitabine; Tumor Immune MicroEnvironment; Systemic immunity; Mucosal immune response; Immune Biomarker

Outcome Measures

Primary Outcomes (1)

• BCG ImmunoScore

  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.

  3 months

Secondary Outcomes (1)

• Recurrence free survival

  12 months

Study Arms (2)

Intravesical Gemcitabine + BCG

EXPERIMENTAL

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.

Drug: Gemcitabine + BCG

Intravesical Bacillus Calmette-Guérin (BCG)

ACTIVE COMPARATOR

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

Drug: BCG (TICE strain)

Interventions

Gemcitabine + BCG DRUG

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.

Intravesical Gemcitabine + BCG

BCG (TICE strain) DRUG

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.

Intravesical Bacillus Calmette-Guérin (BCG)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Queen's University: lead
• Queen's University, Kingston, Ontario: collaborator

Study Sites (1)

Kingston Health Sciences Center

Kingston, Ontario, K7L3N6, Canada

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms; Neoplasms

Interventions

Gemcitabine; BCG Vaccine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

David Robert Siemens, MD

CONTACT

(613) 548-2411; robert.siemens@kingstonhsc.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 15, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)