Actively Recruiting
Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-02
50
Participants Needed
1
Research Sites
318 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Histologically confirmed melanoma diagnosis, any primary or unknown origin
- Presence of BRAFV600 mutation confirmed by CLIA-validated assay
- Melanoma stage III (B/C/D) or stage IV per AJCC 8th edition
- ECOG performance status of 0 to 2
- Adequate lab values: hemoglobin ≥ 8 g/dL, platelets ≥ 75 x 10^9/L, AST and ALT ≤ 2.5 x ULN (≤ 5 x ULN if liver metastases), total bilirubin ≤ 1.5 x ULN and < 2 mg/dL or indirect bilirubin < 1.5 x ULN if total bilirubin >1.5 x ULN, serum creatinine ≤ 2.0 x ULN
- Female participants of childbearing potential must have a negative serum or urine β-HCG test and agree to use highly effective or acceptable contraception excluding hormonal contraceptives
- Male participants must agree to use highly effective or acceptable contraception
You will not qualify if you...
- Prior BRAF and/or MEK inhibitor therapy completed less than 6 months before enrollment or prior progression on BRAF/MEK therapy
- Prior adverse events requiring discontinuation of encorafenib and/or binimetinib due to toxicity
- Major surgery or radiotherapy within 14 days prior to study treatment start or not recovered from side effects
- Unwillingness to avoid grapefruit, pomegranates, star fruits, Seville oranges, or juices containing these during treatment
- Uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are unstable or require steroids or recent radiation within 28 days
- Congestive heart failure requiring treatment (NYHA Class ≥ 3), uncontrolled atrial fibrillation or supraventricular tachycardia, QTcF interval ≥ 500 ms
- Known history of retinal vein occlusion
- Current use of prohibited medications or supplements within 1 week before treatment
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
A
Arnay Marshall
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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