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NCT04511013 · ClinicalTrials.gov registry record · Phase 2
A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
A Phase 2 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, sponsored by SWOG Cancer Research Network.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
- 20
- Study locations
NCT04511013: Recruiting Phase 2 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, sponsored by SWOG Cancer Research Network.
NCT04511013 is a Phase 2 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 112 participants, above the 82-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (37% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04511013, a Phase 2 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, is actively recruiting participants, sponsored by SWOG Cancer Research Network.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.
Primary Outcome
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Conditions Studied
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- DRUG Binimetinib
- DRUG Encorafenib
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Epic Care-Dublin - Dublin
- Bay Area Breast Surgeons Inc - Emeryville
- Epic Care Partners in Cancer Care - Emeryville
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
- Contra Costa Regional Medical Center - Martinez
- Providence Queen of The Valley - Napa
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Thomas Hospital - Fairhope
- Mobile Infirmary Medical Center - Mobile
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2021-01-06 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT04511013 shows while recruiting
NCT04511013 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (37% higher).
The record links to 7 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.
NCT04511013 names 20 study sites across 4 states, led by Alaska, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04511013 about?
NCT04511013 is a clinical study titled "A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases". This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of ...
What is the current status of trial NCT04511013?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2021-01-06. Estimated completion is 2027-06-30.
What conditions does trial NCT04511013 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Metastatic Malignant Neoplasm in the Brain, Clinical Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8, Metastatic Cutaneous Melanoma.
What interventions are being tested in trial NCT04511013?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Binimetinib (DRUG), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT04511013?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04511013 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04511013's enrollment target sits among peer trials
112 19th of 91 higher than 73 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma 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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