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NCT04375527 · ClinicalTrials.gov registry record · Phase 2
Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma
A Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT04375527: Clinical Trial Phase 2 study, sponsored by Jonsson Comprehensive Cancer Center.
NCT04375527 is a Phase 2 study that was terminated before completion, run by Jonsson Comprehensive Cancer Center. 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
NCT04375527, a Phase 2 study, was terminated before completion, sponsored by Jonsson Comprehensive Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This phase II trial studies how well binimetinib and nivolumab work in treating patients with BRAF V600 wildtype melanoma that has spread to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced unresectable) or has spread to other places in the body (metastatic). Binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving binimetinib and nivolumab together may work better in treating patients with melanoma compared to nivolumab alone.
Primary Outcome
Will be defined as the total number of patients with confirmed responses of either complete response or partial response divided by the total number of subjects in the enrolled population per Response Evaluation Criteria in Solid Tumors 1.1 by investigator assessment. Will be calculated along with the corresponding exact one-sided 95% Clopper-Pearson confidence interval.
Interventions
- OTHER Questionnaire Administration
- BIOLOGICAL Nivolumab
- DRUG Binimetinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2020-12-03 |
| Est. Completion | 2024-11-22 |
| Phase | Phase 2 |
Why NCT04375527 stopped before completion
NCT04375527 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 3 interventions - of which Questionnaire Administration is the first listed.
NCT04375527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04375527 about?
NCT04375527 is a clinical study titled "Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma". This phase II trial studies how well binimetinib and nivolumab work in treating patients with BRAF V600 wildtype melanoma that has spread to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced unresectable) or has spread to other places in the body (metastatic). Binimeti...
What is the current status of trial NCT04375527?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2020-12-03. Estimated completion is 2024-11-22.
What interventions are being tested in trial NCT04375527?
The interventions under investigation include: Questionnaire Administration (OTHER), Nivolumab (BIOLOGICAL), Binimetinib (DRUG).
Who is sponsoring clinical trial NCT04375527?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04375527'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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