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

Conditions

• Acral Lentiginous Melanoma
• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Metastatic Cutaneous Melanoma
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Melanoma
• Metastatic Mucosal Melanoma
• Pathologic Stage IV Cutaneous Melanoma AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Binimetinib — DRUG
  Given PO
• Encorafenib — DRUG
  Given PO
• Ipilimumab — BIOLOGICAL
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Jan 6, 2021

Status verified

Sep 2025

Primary completion

Jun 30, 2027

Completion

Jun 30, 2027

Study Design

Enrollment

112 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (encorafenib, binimetinib, nivolumab)
  Patients receive encorafenib PO QD on days 1-28, binimetinib PO BID on days 1-28, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (nivolumab, ipilimumab)
  Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free survival [ Time Frame: From date of registration to date of first documentation of progression, or symptomatic deterioration, or death due to any cause, assessed up to 3 years after randomization ]

Central Contacts

• Catrina Mireles
  2106148808
  [email protected]
• Dana Sparks
  12106148808
  [email protected]

Locations (331)

Find similar trials in Birmingham, AL

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