What side effects are associated with this type of intervention?

The most common treatment for bladder cancer using immune system stimulation is Bacillus Calmette-Guerin (BCG). Side effects of BCG include local symptoms such as cystitis, dysuria, and hematuria, as well as systemic symptoms like fever, malaise, and, rarely, serious infections. Intravesical chemotherapy agents like mitomycin and gemcitabine are also used, with mitomycin causing chemical cystitis and rash, and gemcitabine having a better toxicity profile but still potentially causing local bladder irritation.

What prior FDA approvals exist?

The FDA has approved several treatments for bladder cancer that focus on stimulating the immune system, similar to the Tokyo-172 strain BCG solution. Bacillus Calmette-Guerin (BCG) is a well-established immunotherapy for non-muscle invasive bladder cancer, working by stimulating the immune system to attack cancer cells. Additionally, immune checkpoint inhibitors such as atezolizumab and pembrolizumab have been approved for advanced urothelial carcinoma, enhancing the body's immune response against cancer cells. These treatments represent significant advancements in leveraging the immune system to combat bladder cancer.

What other types of research exist?

Promising novel alternatives to Tokyo-172 strain BCG solution for bladder cancer patients include: 1) Pembrolizumab, an anti-PD-1 antibody, which has shown efficacy in second-line therapy for advanced urothelial carcinoma. 2) Atezolizumab, an anti-PD-L1 antibody, which has been used in patients with platinum-treated locally advanced or metastatic urothelial carcinoma. 3) Enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4, which has shown positive results in patients after platinum and anti-PD-1/PD-L1 therapy. 4) Sacituzumab govitecan, another antibody-drug conjugate, which has been studied in metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors.

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Cancer Vaccine

BCG Strains +/− Vaccine for Bladder Cancer

Phase 3

Waitlist Available

Led By Robert Svatek

Research Sponsored by SWOG Cancer Research Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with T1 disease must have cross-sectional imaging of abdomen/pelvis demonstrating no evidence of metastatic disease (magnetic resonance imaging [MRI] or computed tomography [CT] scan) within 90 days prior to registration; patients with T1 disease must have re-resection confirming =< T1 disease within 90 days prior to registration

Patients must be >= 18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from randomization to first high grade recurrence assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two versions of a treatment called BCG, which uses bacteria to help the immune system fight bladder cancer. It focuses on patients whose bladder cancer has not spread to the muscle. The treatment aims to prevent the cancer from returning by boosting the body's natural defenses. BCG has been used for a long time as an effective treatment for non-muscle-invasive bladder cancer, helping to prevent recurrences and tumor progression.

Who is the study for?

This trial is for adults with high-grade non-muscle invasive bladder cancer, who've had all visible tumors removed and show no signs of metastatic disease. They must not have received prior BCG therapy or have a history of tuberculosis, and should be in good physical condition (Zubrod status 0-2). Pregnant or nursing individuals are excluded, as well as those unwilling to use contraception.

What is being tested?

The study compares the effectiveness of two BCG treatments for bladder cancer: Tokyo-172 strain solution alone versus combined with a vaccine. The goal is to see which method better prevents the return of cancer after treatment by stimulating the immune system.

What are the potential side effects?

BCG treatment can cause flu-like symptoms, irritation in the bladder area, low-grade fever, and fatigue. Rarely it may lead to more serious side effects like an allergic reaction or impact on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My scans show no signs of cancer spread and recent surgery confirms my cancer is still early stage.

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I am 18 years old or older.

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My bladder cancer is classified as high-grade.

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My cancer is not purely squamous cell or adenocarcinoma.

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My cancer does not have micropapillary features.

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My cancer has not spread to my lymph nodes or other parts of my body.

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I have never had tuberculosis.

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I am not planning to undergo any other cancer treatments while participating in this study.

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I have never had BCG treatment directly into my bladder.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I am not taking oral glucocorticoids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from randomization to first high grade recurrence assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from randomization to first high grade recurrence assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from randomization to first high grade recurrence assessed up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

TTHGR for Arm I compared to Arm II

TTHGR for Arm II compared to Arm III

Secondary study objectives

Disease free rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (Tokyo-172 strain BCG solution with priming)Experimental Treatment3 Interventions

PRIME: Patients receive Tokyo-172 strain BCG vaccine once ID. INDUCTION: Within 21 days, patients receive Tokyo-172 strain BCG solution as in Arm II. MAINTENANCE: Patients receive Tokyo-172 strain BCG solution as in Arm II.

Group II: Arm II (Tokyo-172 strain BCG solution)Experimental Treatment2 Interventions

INDUCTION: Patients receive Tokyo-172 strain BCG solution intravesically once a week for 6 weeks. MAINTENANCE: Patients receive Tokyo-172 strain BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.

Group III: Arm I (BCG solution)Active Control2 Interventions

INDUCTION: Patients receive TICE BCG solution intravesically once a week for 6 weeks. MAINTENANCE: Patients receive TICE BCG solution once a week for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 for up to 7 doses.

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bladder cancer include intravesical BCG therapy, chemotherapy, and radiation therapy. BCG therapy, such as the Tokyo-172 strain, works by stimulating the immune system to attack cancer cells in the bladder. This is achieved by instilling a non-infectious form of bacteria into the bladder, which triggers an immune response that targets and destroys cancer cells. Chemotherapy involves the use of drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to destroy cancer cells. These treatments are crucial for bladder cancer patients as they offer different mechanisms to control or eliminate cancer, potentially preserving bladder function and improving survival rates.

[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.]