Actively Recruiting
A Randomized Pilot Trial of Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib and Binimetinib in Advanced Melanoma
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-02
50
Participants Needed
1
Research Sites
49 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
Researchers are studying the rate and timing of melanoma disease relapse after neoadjuvant therapy, focusing on whether participants achieve a complete pathologic response or not, and how postoperative adjuvant treatments affect outcomes. This early phase 1 trial targets patients with advanced melanoma that has a BRAF V600 mutation and evaluates different adjuvant therapies based on individual response to initial treatment. Participants will first receive 24 weeks of neoadjuvant oral encorafenib and binimetinib before planned surgery. After surgery, participants with a complete pathologic response may receive either 24 more weeks of encorafenib and binimetinib or another adjuvant treatment for 24 weeks. Those without a complete response will continue either encorafenib and binimetinib or receive nivolumab for 24 weeks. Imaging scans will be done every 12 weeks for at least one year post-surgery, then every 24 weeks for up to two additional years. During the study, participants will undergo regular imaging to monitor for disease relapse and response to treatment. Researchers will track relapse rates, survival, and response to therapy over several years. Safety and laboratory tests will also be conducted to ensure participant health. The total follow-up period includes evaluations after surgery for at least 24 weeks, with survival tracking up to five years.
CONDITIONS
Brief 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 of any primary or unknown origin
- Melanoma with BRAFV600 mutation, stage III (B/C/D) or stage IV as per AJCC 8th edition
- ECOG performance status of 2 or less
- Adequate lab values: hemoglobin ≥ 8 g/dL; platelets ≥ 75 x 10^9/L; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases; total bilirubin ≤ 1.5 x ULN and < 2 mg/dL or >1.5 x ULN with indirect bilirubin < 1.5 x ULN; serum creatinine ≤ 2.0 x ULN
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception excluding hormonal contraceptives
- Male participants must agree to use effective contraception as described in protocol
You will not qualify if you...
- Prior therapy with BRAF and/or MEK inhibitors within 6 months or progression while on such therapy
- Prior adverse events from encorafenib and/or binimetinib requiring drug discontinuation
- Major surgery or radiotherapy within 14 days before study treatment start or incomplete recovery from such procedures
- Unwillingness to avoid grapefruit, pomegranates, star fruits, Seville oranges, or their juices during treatment
- Uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis requiring steroids or recent radiation within 28 days
- Impaired cardiovascular function including congestive heart failure (NYHA grade ≥3), uncontrolled atrial fibrillation, uncontrolled paroxysmal supraventricular tachycardia, or QTcF interval ≥ 500 ms
- Known history of retinal vein occlusion
- Use of prohibited medications within 1 week before treatment
- Pregnancy or breastfeeding
- Other malignancies interfering with safety or efficacy assessment as judged by physician
- HIV infection must be well controlled with undetectable viral load
- Hepatitis C infection must be treated and cured or have undetectable viral load prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive encorafenib and binimetinib orally in continuous 28-day cycles for 24 weeks before surgery.
Visits every 4 weeks during treatment
Duration - 1 day
Participants undergo planned surgical resection after neoadjuvant treatment.
1 visit (in-person) for surgery
Duration - 24 weeks
Based on pathologic response after surgery, participants receive adjuvant therapy: either encorafenib and binimetinib or nivolumab for 24 weeks, or surveillance if pathologic complete response.
Visits every 4 weeks during adjuvant treatment
Duration - At least 3 years
Participants undergo imaging every 12 weeks for the first year and every 24 weeks for the next two years after surgery to monitor disease status.
Imaging visits every 12 weeks for 1 year, then every 24 weeks for 2 years
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
Research Team
A
Arnay Marshall
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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