Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

NCT04511013 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 112 participants
Start Date 2021-01-06
Est. Completion 2027-06-30
Phase Phase 2

Sponsor

SWOG Cancer Research Network

212 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04511013

The ClinicalTrials.gov registry entry for NCT04511013 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04511013 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Alaska, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04511013?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Binimetinib (DRUG), Encorafenib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04511013?

This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial