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Kinase Inhibitor

Encorafenib + Binimetinib for Melanoma

Phase < 1
Recruiting
Led By Zeynep Eroglu, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female participants of childbearing potential must have a negative serum or urine β-HCG test result and agree to use highly effective or acceptable contraception methods
Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay), either stage III (B/C/D) or Stage IV (AJCC 8th edition).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after surgery, up to 5 years
Awards & highlights

Study Summary

This trial looks at how effective neoadjuvant therapy is in treating cancer, and whether adjuvant therapy after surgery can help prevent disease relapse.

Who is the study for?
Adults with melanoma that has a BRAFV600 mutation, either stage III or IV, can join this trial. They must have good blood counts and organ function, agree to use contraception, and not have had certain treatments or uncontrolled health issues recently. Those with specific drug allergies or who are pregnant cannot participate.Check my eligibility
What is being tested?
The study is testing the effectiveness of Encorafenib and Binimetinib pills before surgery (neoadjuvant therapy) in melanoma patients with a BRAF mutation. After surgery (adjuvant therapy), Nivolumab will be used depending on the initial response to treatment.See study design
What are the potential side effects?
Possible side effects include fatigue, skin rash, vision changes, heart rhythm problems, liver enzyme changes leading to potential liver damage, increased risk of bleeding due to low platelets count and high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who can have children, tested negative for pregnancy, and agree to use effective birth control.
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My melanoma has a BRAFV600 mutation and is either stage III or IV.
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I agree to use effective birth control methods.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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My melanoma diagnosis was confirmed through tissue examination.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after surgery, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and after surgery, up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Disease Relapse
Secondary outcome measures
Overall Response Rate
Overall Survival
Rate of Non-Pathologic Complete Response
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab after Non-Pathologic Complete ResponseExperimental Treatment3 Interventions
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.
Group II: Encorafenib and Binimetinib after Pathologic Complete ResponseExperimental Treatment2 Interventions
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.
Group III: Encorafenib and Binimetinib after Non-Pathologic Complete ResponseExperimental Treatment2 Interventions
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.
Group IV: SurveillanceActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,961 Total Patients Enrolled
51 Trials studying Melanoma
49,404 Patients Enrolled for Melanoma
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,432 Total Patients Enrolled
43 Trials studying Melanoma
3,168 Patients Enrolled for Melanoma
Zeynep Eroglu, MDPrincipal InvestigatorMoffitt Cancer Center
3 Previous Clinical Trials
84 Total Patients Enrolled
1 Trials studying Melanoma
25 Patients Enrolled for Melanoma

Media Library

Binimetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04741997 — Phase < 1
Melanoma Research Study Groups: Encorafenib and Binimetinib after Pathologic Complete Response, Nivolumab after Non-Pathologic Complete Response, Encorafenib and Binimetinib after Non-Pathologic Complete Response, Surveillance
Melanoma Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT04741997 — Phase < 1
Binimetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04741997 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has research been conducted beyond the scope of Encorafenib Pill?

"Currently, 767 trials are researching the efficacy of Encorafenib Pill. Of these examinations, 86 have progressed to Phase 3. The majority of studies for this medication take place in Cambridge, England; however, there are over 42 thousand locations running clinical tests on this pharmaceutical treatment."

Answered by AI

Is this research endeavor in need of more participants?

"Affirmative. Clinicaltrials.gov reveals that this medical investigation, which was initially posted on May 24th 2021, is presently recruiting for 50 participants at one location. It has also been updated most recently on November 2nd 2022."

Answered by AI

How does this research compare to other similar initiatives?

"Since 2011, researchers have been exploring the potential of Encorafenib Pill. Pfizer was responsible for leading the initial trial in 2011 with 183 participants; this led to a Phase 2 drug approval. Currently there are 767 studies active across 2574 cities and 51 countries investigating its effects."

Answered by AI

To what extent is the current clinical trial being populated by participants?

"Affirmative. Per the clinicaltrials.gov website, recruitment for this trial is in progress. The study was published on May 24th 2021 and last modified on November 2nd 2022; 50 participants must be sourced from a single medical site."

Answered by AI

To what ailments can Encorafenib Pill be administered to provide relief?

"Encorafenib Pill has been proven to be an effective management strategy for malignant neoplasms, unresectable melanoma and squamous cell carcinoma."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma
2021. "Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04741997.
~18 spots leftby Jan 2026
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