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NCT04655157 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma
A Phase 1 study, sponsored by Jason J. Luke, MD.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT04655157 is a Phase 1 study that was terminated before completion, run by Jason J. Luke, MD. The registered enrollment target is 2 participants.
The verdict
NCT04655157, a Phase 1 study, was terminated before completion, sponsored by Jason J. Luke, MD.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
Patients with unresectable or metastatic BRAF-mutant melanoma high-risk patients will be given 450 mg orally (PO) daily (QD) plus binimetinib 45 mg PO twice daily (BID) together with nivolumab administered intravenously (IV) at 3mg/kg and ipilimumab administered IV at 1 mg/kg every 3 weeks for 4 doses, followed by nivolumab administered IV at 480mg every 4 weeks until progression or discontinuation due to toxicity. Concurrently, a triple therapy arm will be explored with encorafenib 300 mg PO QD together with ipilimumab administered IV at 1mg/kg and nivolumab 3mg/kg IV every 3 weeks for 4 doses, followed by nivolumab administered at 480mg every 4 weeks until progression or discontinuation due to toxicity. Tolerability of the two arms will be compared, and a recommended phase 2 dose (RP2D) will be determined. After determination of treatment schedule, expansion cohorts will further explore the preliminary efficacy and further describe the toxicity profile of the triplet or quadruplet regimen in high-risk cohorts including symptomatic brain metastases or liver metastases with elevated lactate dehydrogenase (LDH) or bulky systemic disease burden.
Interventions
- DRUG binimetinib
- DRUG nivolumab
- DRUG ipilimumab
- DRUG encorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-05-28 |
| Est. Completion | 2022-09-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04655157
The ClinicalTrials.gov registry entry for NCT04655157 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jason J. Luke, MD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which binimetinib is the first listed.
NCT04655157 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04655157 about?
NCT04655157 is a clinical study titled "Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma". Patients with unresectable or metastatic BRAF-mutant melanoma high-risk patients will be given 450 mg orally (PO) daily (QD) plus binimetinib 45 mg PO twice daily (BID) together with nivolumab administered intravenously (IV) at 3mg/kg and ipilimumab administered IV at 1 mg/kg every 3 weeks for 4 dos...
What is the current status of trial NCT04655157?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2021-05-28. Estimated completion is 2022-09-20.
What interventions are being tested in trial NCT04655157?
The interventions under investigation include: binimetinib (DRUG), nivolumab (DRUG), ipilimumab (DRUG), encorafenib (DRUG).
Who is sponsoring clinical trial NCT04655157?
This trial is sponsored by Jason J. Luke, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
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