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NCT04221438 · ClinicalTrials.gov registry record · Phase 2
Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement
A Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04221438: Clinical Trial Phase 2 study, sponsored by ECOG-ACRIN Cancer Research Group.
NCT04221438 is a Phase 2 study that was terminated before completion, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04221438, a Phase 2 study, was terminated before completion, sponsored by ECOG-ACRIN Cancer Research Group.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase II trial studies how well encorafenib and binimetinib work before surgery in treating patients with BRAF V600-mutated stage IIIB-D melanoma that has spread to the lymph nodes. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial also studies how well 18F-FLT positron emission tomography (PET)/computed tomography (CT) works in predicting the response of melanoma to encorafenib and binimetinib. 18F-FLT is an imaging agent, sometimes called a tracer. PET and CT are types of imaging scans. Using 18F-FLT PET/CT together with encorafenib and binimetinib may provide more information on melanoma over time.
Primary Outcome
Pathologic complete response (pCR) is defined as complete absence of viable tumor in the treated tumor bed. Partial pathologic response (pPR) is defined as less than or equal to 50% of the treated tumor bed is occupied by viable tumor cells. Pathologic non-response is defined as great than 50% of the treated tumor bed is occupied by viable tumor cells.
Interventions
- PROCEDURE Conventional Surgery
- DRUG Binimetinib
- DRUG Encorafenib
- OTHER Fluorothymidine F-18
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-09-22 |
| Est. Completion | 2025-01-31 |
| Phase | Phase 2 |
Why NCT04221438 stopped before completion
NCT04221438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Conventional Surgery is the first listed.
NCT04221438 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04221438 about?
NCT04221438 is a clinical study titled "Testing Treatment With Encorafenib and Binimetinib Before Surgery for Melanoma With Lymph Node Involvement". This phase II trial studies how well encorafenib and binimetinib work before surgery in treating patients with BRAF V600-mutated stage IIIB-D melanoma that has spread to the lymph nodes. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell gr...
What is the current status of trial NCT04221438?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2021-09-22. Estimated completion is 2025-01-31.
What interventions are being tested in trial NCT04221438?
The interventions under investigation include: Conventional Surgery (PROCEDURE), Binimetinib (DRUG), Encorafenib (DRUG), Fluorothymidine F-18 (OTHER).
Who is sponsoring clinical trial NCT04221438?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04221438's enrollment target sits among peer trials
3 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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