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Vaccine

Gemcitabine + Docetaxel vs BCG for Bladder Cancer (BRIDGE Trial)

Phase 3
Recruiting
Research Sponsored by Eastern Cooperative Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must be > 18 years of age.
Patient must have ECOG Performance Status 0-2.
Must not have
Patients with a history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e., either cytology, biopsy, or imaging) that demonstrates no evidence of residual disease are eligible.
Patient must not have any prior or current history of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 90 days prior to randomization. The radiographic imaging includes a CT Scan OR MRI of the abdomen/pelvis with intravenous contrast.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial tests if a new treatment, Gemcitabine + Docetaxel, is better or worse than the usual BCG therapy for bladder cancer. Primary goal is to measure event free survival, secondary objectives include changes in cancer-specific QOL, cystectomy free survival, progression free survival, and safety/toxicity.

Who is the study for?
This trial is for adults over 18 with high-grade non-muscle invasive bladder cancer who haven't had previous intravesical therapy, except perioperative chemo at TURBT time. They must have good performance status (able to carry out daily activities), no severe heart disease, and adequate organ function. Pregnant or breastfeeding individuals are excluded, as well as those with a history of muscle-invasive or advanced urothelial carcinoma.Check my eligibility
What is being tested?
The study compares the effectiveness of Gemcitabine + Docetaxel (GEMDOCE) versus Bacillus Calmette-Guerin (BCG) in treating patients new to BCG treatment for bladder cancer. It measures how long patients remain free from cancer events after these treatments and assesses quality of life, cystectomy-free survival, progression-free survival, safety, and toxicity.See study design
What are the potential side effects?
Potential side effects include allergic reactions to docetaxel or drugs containing polysorbate 80. Both GEMDOCE and BCG can cause immune system impacts leading to infection risks; GEMDOCE may also affect blood cell counts and liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I am able to care for myself and perform daily activities.
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I had hepatitis C but am cured, or I'm being treated with an undetectable viral load.
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My hepatitis B virus is under control with treatment.
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My visible bladder tumors have been surgically removed before joining this study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had non-invasive bladder cancer, treated and confirmed clear on follow-up tests.
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I have never had advanced or spreading bladder cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-Free Survival
Secondary outcome measures
Cystectomy free survival
Progression Free Survival
Quality of Life EORTC NMIBC-24
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment1 Intervention
BCG
Group II: Arm AExperimental Treatment2 Interventions
Gemcitabine + Docetaxel
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Docetaxel
1995
Completed Phase 4
~5620

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
Gemcitabine and Docetaxel are chemotherapeutic agents used in the treatment of bladder cancer, often administered intravesically. Gemcitabine works by inhibiting DNA synthesis, leading to cell death, while Docetaxel stabilizes microtubules, preventing cell division. These mechanisms are crucial as they target rapidly dividing cancer cells, reducing tumor growth. For bladder cancer patients, these treatments offer a non-surgical option that can preserve bladder function and improve quality of life. Additionally, BCG therapy, an immunotherapy, stimulates the immune system to attack cancer cells, and newer immunotherapies target specific pathways to enhance immune response. Understanding these mechanisms helps in selecting the most appropriate treatment based on individual patient needs and tumor characteristics.
[The role of immunotherapy in the modern treatment of urothelial carcinoma].Emerging drugs for urothelial carcinoma.

Find a Location

Who is running the clinical trial?

Eastern Cooperative Oncology GroupLead Sponsor
268 Previous Clinical Trials
150,725 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,052 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,531 Total Patients Enrolled

Media Library

Bacillus Calmette Guerin (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05538663 — Phase 3
Bladder Cancer Research Study Groups: Arm B, Arm A
Bladder Cancer Clinical Trial 2023: Bacillus Calmette Guerin Highlights & Side Effects. Trial Name: NCT05538663 — Phase 3
Bacillus Calmette Guerin (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05538663 — Phase 3
~580 spots leftby Nov 2029