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NCT04164082 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer
A Phase 2 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 161
- Enrollment target
- 20
- Study locations
NCT04164082 is a Phase 2 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 161 participants, below the 223-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 6 states.
The verdict
NCT04164082, a Phase 2 study of Stage 0a Bladder Cancer AJCC v8 and Stage I Bladder Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 161 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy Procedure
- PROCEDURE Cystoscopy
- DRUG Gemcitabine Hydrochloride
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Cedars Sinai Medical Center - Los Angeles
- University of California Davis Comprehensive Cancer Center - Sacramento
Colorado
- Rocky Mountain Cancer Centers-Aurora - Aurora
- The Medical Center of Aurora - Aurora
- Boulder Community Foothills Hospital - Boulder
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 161 participants |
| Start Date | 2020-03-18 |
| Est. Completion | 2026-12-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04164082
The ClinicalTrials.gov registry entry for NCT04164082 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 161 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 223-participant average among 7 other Stage 0a Bladder Cancer AJCC v8 trials with a reported enrollment target (28% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Stage 0a Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04164082 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Alaska, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT04164082 about?
NCT04164082 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer". This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of ...
What is the current status of trial NCT04164082?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 161 participants. The study started on 2020-03-18. Estimated completion is 2026-12-09.
What conditions does trial NCT04164082 study?
This clinical trial studies the following conditions: Stage 0a Bladder Cancer AJCC v8, Stage I Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Non-Muscle Invasive Bladder Urothelial Carcinoma, Bladder Flat Urothelial Carcinoma In Situ.
What interventions are being tested in trial NCT04164082?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Cystoscopy (PROCEDURE), Gemcitabine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04164082?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04164082 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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