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NCT03854474 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma
A Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 20
- Study locations
NCT03854474: Active Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03854474 is a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 30 participants, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03854474, a Phase 1 study of Metastatic Urothelial Carcinoma and Locally Advanced Urothelial Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase I/II trial studies the side effects and best dose of tazemetostat and how well it works when given together with pembrolizumab in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced ) or from where it first started (primary site) to other places in the body (metastatic). Tazemetostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving tazemetostat and pembrolizumab may work better in treating patients with urothelial carcinoma compared to pembrolizumab without tazemetostat.
Primary Outcome
The 3+3 rule will be used to define the RP2D, such that for each cohort, the highest level in which =\< 1 out of 6 patients experienced dose limiting toxicity (DLT), at or below the maximum administered dose, would constitute the RP2D. If =\< 1 of 6 patients experienced DLTs at the maximum administered dose, then the maximum administered dose will be declared RP2D for that cohort.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Tazemetostat
Study Locations (20)
Connecticut
- Smilow Cancer Hospital-Derby Care Center - Derby
- Smilow Cancer Hospital Care Center-Fairfield - Fairfield
- Smilow Cancer Hospital Care Center - Guilford - Guilford
- Smilow Cancer Hospital Care Center at Saint Francis - Hartford
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
- Yale-New Haven Hospital North Haven Medical Center - North Haven
- Smilow Cancer Hospital-Orange Care Center - Orange
- Smilow Cancer Hospital-Torrington Care Center - Torrington
- Smilow Cancer Hospital Care Center-Trumbull - Trumbull
- Smilow Cancer Hospital-Waterbury Care Center - Waterbury
- Smilow Cancer Hospital Care Center - Waterford - Waterford
Kansas
- University of Kansas Clinical Research Center - Fairway
- HaysMed - Hays
- Lawrence Memorial Hospital - Lawrence
- The University of Kansas Cancer Center - Olathe - Olathe
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-11-18 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT03854474 still lists
NCT03854474 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 130-participant average among 30 other Metastatic Urothelial Carcinoma trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with Metastatic Urothelial Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT03854474 names 20 study sites across 5 states, led by Connecticut, Kansas, Arizona.
Frequently Asked Questions
What is clinical trial NCT03854474 about?
NCT03854474 is a clinical study titled "Testing the Addition of Tazemetostat to the Immunotherapy Drug, Pembrolizumab (MK-3475), in Advanced Urothelial Carcinoma". This phase I/II trial studies the side effects and best dose of tazemetostat and how well it works when given together with pembrolizumab in treating patients with urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced ) or from where it first started (primary site) t...
What is the current status of trial NCT03854474?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-11-18. Estimated completion is 2026-06-30.
What conditions does trial NCT03854474 study?
This clinical trial studies the following conditions: Metastatic Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Stage IV Bladder Cancer AJCC v8, Stage III Bladder Cancer AJCC v8.
What interventions are being tested in trial NCT03854474?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Tazemetostat (DRUG).
Who is sponsoring clinical trial NCT03854474?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03854474 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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