Gemcitabine + BCG for Bladder Cancer

(BCG-TIME Trial)

Overseen By David Robert Siemens, MD

Age: 65+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Queen's University

Must not be taking: Steroids

Disqualifiers: Prior BCG, Immunosuppressed, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to evaluate treatment effectiveness for individuals with high-risk non-muscle invasive bladder cancer. Researchers are assessing whether adding the chemotherapy drug gemcitabine to BCG therapy (Bacillus Calmette-Guérin, a type of immunotherapy) offers more benefits than using BCG alone. They aim to identify early bodily indicators of treatment efficacy. Individuals who have not previously received BCG and have specific types of bladder cancer (Ta or T1 high grade, with or without CIS) may qualify for this study. As a Phase 1, Phase 2 trial, this research seeks to understand the treatment's function in participants and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive drugs like steroids, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that combining gemcitabine with BCG may offer a promising treatment for non-muscle invasive bladder cancer. Studies have found this combination effective and safe for patients who have undergone previous treatments. In one past study involving patients with high-grade cancer, the treatment was well-tolerated, with most patients experiencing no severe side effects.

Gemcitabine with BCG has shown strong early results, indicating effectiveness with minimal unwanted effects. Safety data from these studies support further testing in clinical trials. For those considering joining a clinical trial for this treatment, existing research suggests it is generally safe based on earlier studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination treatment of Gemcitabine and Bacillus Calmette-Guérin (BCG) for bladder cancer because it aims to enhance the effectiveness of existing BCG therapy, which is a standard treatment. BCG is an immunotherapy that helps the body's immune system attack cancer cells, but by adding Gemcitabine, a chemotherapy drug, directly into the bladder, the treatment may work more effectively by targeting cancer cells in multiple ways. This dual approach could potentially improve patient outcomes by reducing cancer recurrence more effectively than BCG alone.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

Research shows that using gemcitabine with BCG holds promise for treating a type of bladder cancer that hasn't spread to the muscle. In this trial, some participants will receive the combination of gemcitabine and BCG, which has proven effective and safe for patients previously treated with BCG. Another group will receive BCG alone. Gemcitabine alone is usually less effective than BCG for patients who have never had BCG treatment. However, for those who have already received BCG, the combined treatment might be a strong option. Studies suggest that using gemcitabine and BCG together could improve the treatment response compared to using each one separately. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with high-risk non-muscle invasive bladder cancer (NMIBC). Participants should be suitable for BCG immunotherapy. Specific eligibility criteria are not provided, but typically include factors like age, health status, and cancer stage.

Inclusion Criteria

I am older than 65.

I have bladder cancer and have never received BCG treatment.

My bladder cancer is non-muscle invasive and high grade.

Exclusion Criteria

I am on immunosuppressants, such as steroids or after a transplant.

I have previously received BCG immunotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravesical Gemcitabine + BCG or intravesical BCG alone, with weekly instillations

5-6 weeks

5-6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3 months for complete response and 12 months for recurrence-free survival

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• BCG
• Gemcitabine

Trial Overview The study compares standard BCG therapy to a combination of Gemcitabine and BCG in treating NMIBC. It aims to develop biomarker tests for early response to these treatments by analyzing tumor tissue and blood samples.

How Is the Trial Designed?

Group I: Intravesical Gemcitabine + BCG Experimental Treatment 1 Intervention

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 II: Intravesical Bacillus Calmette-Guérin (BCG) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Queen's University, Kingston, Ontario

Collaborator

Trials

9

Recruited

83,900+

Citations

1. urotoday.com urotoday.com/conference-highlights/suo-2024/suo-2024-bladder-cancer/156743-suo-2024-initial-results-of-a-multicenter-phase-ii-trial-of-intravesical-gemcitabine-plus-bcg-for-patients-with-bcg-exposed-non-muscle-invasive-bladder-cancer.html

SUO 2024: Initial Results of a Multicenter Phase II trial ... What about BCG compared to gemcitabine? In the BCG-naïve setting, BCG has been shown to be more effective than gemcitabine. In the BCG refractory setting, the ...

2. targetedonc.com targetedonc.com/view/gemcitabine-bcg-shows-early-promise-in-bcg-exposed-nmibc

Gemcitabine-BCG Shows Early Promise in BCG-Exposed ... BCG with gemcitabine was linked to strong early oncological efficacy and safety in previously treated patients with non–muscle-invasive bladder cancer.

3. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-471942

New Treatment Options for Non–Muscle-Invasive Bladder ... In a multi-institutional retrospective analysis, sequential gemcitabine and docetaxel demonstrated favorable efficacy and safety as a salvage ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38653234/

A Phase 2 Trial of Intravesical Gemcitabine and Docetaxel ... In this single-arm phase 2 trial, GemDoce was well tolerated with promising efficacy for patients with BCG-naïve high-risk NMIBC.

5. auajournals.org auajournals.org/doi/10.1097/JU.0000000000004472

Gemcitabine vs Bacillus Calmette-Guérin for Intravesical ... Gemcitabine is associated with a higher risk of recurrence than BCG in treatment-naïve patients with IR-NMIBC. However, both treatments show comparable ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39797535/

Gemcitabine and docetaxel for high-risk non-muscle- ... The intravesical Gem/Doce regimen demonstrated promising short-term oncological outcomes and was well tolerated in this cohort of patients ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-01651

TAR-200 for Bacillus Calmette-Guérin–Unresponsive High- ... Many patients with high-risk non–muscle-invasive bladder cancer (NMIBC) experience disease recurrence (12%-60%) or progression (2%-15%) within 1 ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1558767325001454

A Systematic Review and Meta-Analysis of the ... Our analysis showed CR rates of 36%, 25%, and 18% at 3, 6, and 12 months, respectively. Although BCG remains an established treatment for NMIBC, ...