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NCT03543969 · ClinicalTrials.gov registry record · Early Phase 1
Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma
A Early Phase 1 study of Melanoma (Skin) and Skin Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Early Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT03543969: Active Early Phase 1 study of Melanoma (Skin) and Skin Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03543969 is a Early Phase 1 study of Melanoma (Skin) and Skin Cancer that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 14 participants, below the 137-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03543969, a Early Phase 1 study of Melanoma (Skin) and Skin Cancer, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This pilot early phase I trial studies how well encorafenib, binimetinib, and nivolumab work in treating patients with BRAF mutant stage IIIC-IV melanoma. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with nivolumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may kill more tumor cells.
Primary Outcome
Number of participants who reach 8 weeks with the prescribed on/off schedule without progression of disease. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Binimetinib
- DRUG Encorafenib
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2026-12 |
| Phase | Early Phase 1 |
What the registry record for NCT03543969 still lists
NCT03543969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 137-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target (90% lower).
The record links to 4 conditions, with Melanoma (Skin) appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03543969 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03543969 about?
NCT03543969 is a clinical study titled "Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma". This pilot early phase I trial studies how well encorafenib, binimetinib, and nivolumab work in treating patients with BRAF mutant stage IIIC-IV melanoma. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with nivolum...
What is the current status of trial NCT03543969?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2018-06-14. Estimated completion is 2026-12.
What conditions does trial NCT03543969 study?
This clinical trial studies the following conditions: Melanoma (Skin), Skin Cancer, Skin Carcinoma, Skin Melanoma.
What interventions are being tested in trial NCT03543969?
The interventions under investigation include: Nivolumab (DRUG), Binimetinib (DRUG), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT03543969?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03543969 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03543969's enrollment target sits among peer trials
14 29th of 30 higher than 1 of 30 other Melanoma (Skin) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma (Skin) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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