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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).

Must not have

Current use of a prohibited medication (including herbal medications, supplements, or foods) as described in protocol

Consuming grapefruit, pomegranates, star fruits, Seville oranges or products containing the juice during the study while taking encorafenib/binimetinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after surgery, up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medication or supplements that are not allowed in the study.

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I will not consume grapefruit, pomegranates, star fruits, Seville oranges or their juices while taking encorafenib/binimetinib.

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I have HIV without effective treatment and my viral load is not undetectable.

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My condition worsened while I was on BRAF/MEK inhibitor therapy.

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I haven't had major surgery or radiotherapy in the last 2 weeks.

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I had to stop taking encorafenib/binimetinib due to side effects.

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I do not have serious heart issues like untreated heart failure or irregular heartbeats.

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I do not have uncontrolled brain tumors or cancer in my brain's lining.

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I have a history of blocked veins in my retina.

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I have hepatitis C that is either untreated, not cured, or currently being treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after surgery, up to 5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Disease Relapse

Secondary study objectives

Overall Response Rate

Overall Survival

Rate of Non-Pathologic Complete Response

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2015

Completed Phase 3

~4010

0 / 16Eligibility criteria met