Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT04741997
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • BRAF V600 Mutation
  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Encorafenib Pill — DRUG
    Encorafenib 450 mg will be administered orally once per day in continuous 28-day cycles
  • Binimetinib Pill — DRUG
    Binimetinib 45 mg will be administered orally twice per day in continuous 28-day cycles
  • Nivolumab — DRUG
    Nivolumab will be administered at a dose of 480 mg IV infusion over 30 minutes every 4 weeks.

Study Details

The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.

Key Dates

Start date
May 24, 2021
Status verified
Feb 2026
Primary completion
Jul 22, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Surveillance
    Participants will receive 24 weeks of neoadjuvant encorafenib and binimetinib and then proceed to planned resection. If participants have pathologic complete response they will receive adjuvant treatment for 24 weeks. Imaging will be conducted every 12 weeks for at least one year after surgery, and every 24 weeks for at least two years post-surgery.
  • Experimental: Encorafenib and Binimetinib after Pathologic Complete Response
    Participants will receive 24 weeks of neoadjuvant encorafenib and binimetinib and then proceed to planned resection. If participants have pathologic complete response they will continue to receive encorafenib and binimetinib for 24 more weeks. Imaging will be conducted every 12 weeks for at least one year after surgery, and every 24 weeks for at least two years post-surgery.
  • Experimental: Encorafenib and Binimetinib after Non-Pathologic Complete Response
    Participants will receive 24 weeks of neoadjuvant encorafenib and binimetinib and then proceed to planned resection. If participants have non-pathologic complete response they will continue to receive encorafenib and binimetinib for 24 more weeks. Imaging will be conducted every 12 weeks for at least one year after surgery, and every 24 weeks for at least two years post-surgery.
  • Experimental: Nivolumab after Non-Pathologic Complete Response
    Participants will receive 24 weeks of neoadjuvant encorafenib and binimetinib and then proceed to planned resection. If participants have non-pathologic complete response they will receive nivolumab for 24 weeks. Imaging will be conducted every 12 weeks for at least one year after surgery, and every 24 weeks for at least two years post-surgery.

Primary Outcome Measure

Rate of Disease Relapse [ Time Frame: After surgery up to 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Zeynep Eroglu, MD (PRINCIPAL_INVESTIGATOR)
Andrew Brohl, MD (SUB_INVESTIGATOR)
Nikhil Khushaslani, MD (SUB_INVESTIGATOR)
Joseph Markowitz, MD, PhD (SUB_INVESTIGATOR)
Ahmad Tarhini, MD, PhD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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