Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07064863

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

NMIBC Bladder (Urothelial, Transitional Cell) Cancer Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-Muscle Invasive Bladder Neoplasms Non-Muscle Invasive Bladder Urothelial Carcinoma Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Bladder

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kingston Health Sciences Center

Kingston, Ontario, K7L3N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. BCG ImmunoScore

    Time frame: 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 outcomes

  1. Recurrence free survival

    Time frame: 12 months

    Recurrence free survival at 12 months post treatment initiation.

Study contacts

Contact information is provided by the study sponsor or research team.

David Robert Siemens, MD

CONTACT

[email protected]

(613) 548-2411

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Queen's University, Kingston, Ontario

Registry information

Official study title

BCG-TIME: Improving Response to Bacillus Calmette Guerin Immunotherapy in High-risk Non-muscle Invasive Bladder Cancer Via a Tumor Immune MicroEnvironment Based Biomarker.

Acronym: BCG-TIME

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.