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NCT04557956 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment
A Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 17
- Study locations
NCT04557956 is a Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 16 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (81% lower). The trial reports 17 study locations across 8 states.
The verdict
NCT04557956, a Phase 1 study of Metastatic Melanoma and Clinical Stage IV Cutaneous Melanoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 17
- Study locations
Study Summary
This phase I/II trial investigates the best dose, possible benefits and/or side effects of tazemetostat in combination with dabrafenib and trametinib in treating patients with melanoma that has a specific mutation in the BRAF gene (BRAFV600) and that has spread from where it first started (primary site) to other places in the body (metastatic). Tazemetostat, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving tazemetostat in combination with dabrafenib and trametinib may stabilize BRAFV600 mutated melanoma.
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- PROCEDURE Echocardiography Test
- DRUG Dabrafenib Mesylate
Study Locations (17)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Missouri
- Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
- Siteman Cancer Center at West County Hospital - Creve Coeur
- Washington University School of Medicine - St Louis
- Siteman Cancer Center-South County - St Louis
- Siteman Cancer Center at Christian Hospital - St Louis
Wisconsin
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center - Madison
- University of Wisconsin Carbone Cancer Center - University Hospital - Madison
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Illinois
- Northwestern University - Chicago
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Utah
- Huntsman Cancer Institute/University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2021-08-19 |
| Est. Completion | 2027-03-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04557956
The ClinicalTrials.gov registry entry for NCT04557956 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (81% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT04557956 reports 17 study locations spanning 8 distinct geographic areas - top geographies include Florida, Missouri, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04557956 about?
NCT04557956 is a clinical study titled "Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment". This phase I/II trial investigates the best dose, possible benefits and/or side effects of tazemetostat in combination with dabrafenib and trametinib in treating patients with melanoma that has a specific mutation in the BRAF gene (BRAFV600) and that has spread from where it first started (primary s...
What is the current status of trial NCT04557956?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2021-08-19. Estimated completion is 2027-03-11.
What conditions does trial NCT04557956 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Clinical Stage IV Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT04557956?
The interventions under investigation include: Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE), Dabrafenib Mesylate (DRUG).
Who is sponsoring clinical trial NCT04557956?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04557956 being conducted?
This trial has 17 study locations across Florida, Georgia, Illinois, Missouri, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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