NCT02537600

Vemurafenib and Cobimetinib Combination in BRAF Mutated Melanoma With Brain Metastasis

Evaluation of Cobimetinib + Vemurafenib Combination Treatment in Patients With Brain Metastasis BRAFV600 Mutated Cutaneous Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Center Eugene Marquis · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine wether cobimetinib + vemurafenib combination treatment is effective in the treatment of BRAFV600-mutated melanoma patients with brain metastasis

Detailed description

Patients will be enrolled into 3 cohorts: * Cohort A : Neurologically asymptomatic patients who have not received prior local treatment ; * Cohort B. Neurologically asymptomatic patients who have received prior local treatment; * Cohort C. Neurologically symptomatic patients who have or have not received prior local treatment Every patients will be treated with Vemurafenib 960 mg PO, twice daily from D1 to D28, continuously Cobimetinib 60 mg PO, once daily, from D1 to D21 - 1 cycle = 28 days Treatment will be administered until progression (intracranial or extracranial), unacceptable toxicity, withdrawal of consent, death or decision of the treating investigator. Patients who develop intracranial or extracranial progression and who, in the opinion of the treating investigator, could benefit from continuing treatment may continue treatment with vemurafenib and cobimetinib after approval from the principal investigator. Patients who discontinue the study treatment will undergo an end-of-treatment visit 30 days after the last dose of vemurafenib and/or cobimetinib. Patients who discontinue the study treatment for any reason other than progression (e.g. toxicity) must be followed up every 8 weeks unless they withdraw their consent.

Conditions

• Malignant Melanoma

Interventions

Type	Name	Description
DRUG	Cobimetinib + Vemurafenib combination treatment	Patients will be treated from day 1 to day 28 with Vemurafenib and from day 1 to day 21 with Cobimetinib. Day 1 to Day 28 corresponds to one cycle of treatment.

Timeline

• Start date: 2015-12-01
• Primary completion: 2019-11-06
• Completion: 2019-11-06
• First posted: 2015-09-01
• Last updated: 2020-01-27

Locations

17 sites across 1 country: France