Encorafenib + Binimetinib Before Surgery for Melanoma

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: ECOG-ACRIN Cancer Research Group

Must not be taking: BRAF inhibitors, MEK inhibitors

Disqualifiers: Distant metastases, Active infection, Hepatitis B/C, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

3 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well encorafenib and binimetinib work before surgery in treating patients with BRAF V600-mutated stage IIIB-D melanoma that has spread to the lymph nodes. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial also studies how well 18F-FLT positron emission tomography (PET)/computed tomography (CT) works in predicting the response of melanoma to encorafenib and binimetinib. 18F-FLT is an imaging agent, sometimes called a tracer. PET and CT are types of imaging scans. Using 18F-FLT PET/CT together with encorafenib and binimetinib may provide more information on melanoma over time.

Research Team

Leslie A Fecher

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults with stage IIIB-D melanoma that has spread to lymph nodes and have a BRAF V600 mutation. They must be able to take oral meds, lie still for PET/CT scans, use contraception if of childbearing potential, and not have distant metastases or other serious health issues. HIV-positive patients can join if their condition is stable.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

I can take pills by mouth.

I am using or willing to use effective birth control or abstain from sex during and after the study.

Exclusion Criteria

I haven't had a stroke or blood clot in the last 3 months.

I do not have a muscle disorder that increases my CK levels.

My cancer has not spread to distant parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Patients receive encorafenib and binimetinib for up to 2 cycles, with PET/CT scans to evaluate response

8-9 weeks

Multiple visits for drug administration and imaging

Surgical Resection

Patients undergo surgery to remove melanoma after neoadjuvant treatment

Within 2 weeks post-treatment

Adjuvant Treatment

Patients resume treatment with encorafenib and binimetinib for up to 11 cycles post-surgery

11 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Every 3 months for 1 year, then every 6 months for 3 years

Treatment Details

Interventions

• Binimetinib
• Computed Tomography
• Conventional Surgery
• Encorafenib
• Positron Emission Tomography

Trial Overview The effectiveness of Encorafenib and Binimetinib before surgery in treating melanoma with lymph node involvement is being tested. The study also evaluates how well an imaging agent (18F-FLT) used in PET/CT scans predicts the response to these drugs.

Participant Groups

Group I: Neoadjuvant encorafenib + binimetinib, surgery, adjuvant encorafenib + binimetinib Experimental Treatment 4 Interventions

NEOADJUVANT TREATMENT: Patients receive 18F-FLT IV and undergo a PET/CT scan approximately 60 minutes later. Within 2 weeks, patients receive encorafenib PO QD and binimetinib PO BID on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive 18F-FLT IV and undergo a second PET/CT scan approximately 60 minutes later. SURGICAL RESECTION: Within 2 weeks of completing therapy with encorafenib and binimetinib, patients undergo surgery. ADJUVANT TREATMENT: Within 2-7 days after surgery, patients resume treatment with encorafenib PO QD and binimetinib PO BID on days 1-28. Treatment repeats every 28 days for up to 11 cycles in the absence of disease progression or unacceptable toxicity.

Binimetinib is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

Approved in European Union as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Approved in Canada as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600E or V600K mutation

Approved in Japan as Mektovi for:

• Unresectable or metastatic melanoma with a BRAF V600 mutation

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+