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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravesical 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.

Group Type EXPERIMENTAL

Gemcitabine + BCG

Intervention Type 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 Bacillus Calmette-Guérin (BCG)

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

Group Type ACTIVE_COMPARATOR

BCG (TICE strain)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.