A Study to Evaluate a Standard-dose and High- dose Regimen of Encorafenib + Binimetinib in Patients with BRAFV600-mutant Melanoma Brain Metastasis

Overview

About this study

The purpose of this study is to assess the safety, effectiveness and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Histologically confirmed diagnosis of melanoma.
  • Presence of B-RAF proto-oncogene, V600 mutant (BRAFV600) mutation in tumor tissue previously determined by a local assay at any time prior to Screening or by a central laboratory during Screening. 
  • Metastatic disease to the brain with at least 1 parenchymal brain lesion ≥ 0.5 cm and ≤ 4 cm, defined as a magnetic resonance imaging (MRI) contrast-enhancing lesion that may be accurately measured in at least 1 dimension. 
  • Patients may have received no more than 1 prior line of checkpoint inhibitor therapy. 
  • An Eastern Cooperation Oncology Group Performance Status (ECOG PS) of 0 or 1 and Karnofsky score ≥ 80.
  • Adequate bone marrow, organ function and laboratory parameters.

Exclusion Criteria:

  • Patients with symptomatic brain metastasis. 
  • Patients requiring corticosteroids for brain metastasis. 
  • Uveal or mucosal melanoma. 
  • History of or current leptomeningeal metastases. 
  • Prior local treatment for brain metastasis, including whole brain radiation therapy, stereotactic radiosurgery or craniotomy. 
  • Either of the following:
    • Radiation therapy to non-brain visceral metastasis within 2 weeks prior to start of study treatment; 
    • Continuous or intermittent small-molecule therapeutics or investigational agents within 5 half-lives of the agent (or within 4 weeks prior to start of study treatment, when half-life is unknown).
  • Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 12 months prior to enrollment.
  • Patients treated in the adjuvant setting with B-RAF proto-oncogene, serine/threonine kinase (BRAF) or mitogen-activated protein kinase (MEK) inhibitors ≥ 12 months prior to enrollment are eligible.
  • Patients who received BRAF or MEK inhibitors in the metastatic setting are excluded. 
  • Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before starting study treatment.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yiyi Yan, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Yiyi Yan, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Yiyi Yan, M.D., Ph.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20474785

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