NCT03430947

Vemurafenib Plus Cobimetinib After Radiosurgery in Patients With BRAF-mutant Melanoma Brain Metastases

An Open-label Phase II Multicenter Study of Vemurafenib (Zelboraf®) Plus Cobimetinib (Cotellic®) After Radiosurgery in Patients With Active BRAF-V600-mutant Melanoma Brain Metastases

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Technische Universität Dresden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open label, non-randomised study of vemurafenib and cobimetinib after radiosurgery in adult patients with BRAFV600-mutant melanoma brain metastases. All patients will receive vemurafenib 960 mg twice a day on days 1 - 28 combined with cobimetinib 60 mg once a day on days 1 - 21 of each 28-day treatment cycle until disease progression, drug toxicity or death. The primary objective of this study is to determine the best overall response rate (BORR) in the brain. The extracranial BORR, intra- and extracranial duration of response, progression-free survival and overall survival, adverse events, quality of life and radiomics features predicting long-term local control of brain metastases and treatment-related toxicity will also be examined.

Conditions

• Malignant Melanoma Stage IV
• BRAF V600 Mutation
• Brain Metastases

Interventions

Type	Name	Description
DRUG	Vemurafenib	Vemurafenib (960 mg twice a day) will be taken on days 1 - 28 of each 28-day treatment cycle.
DRUG	Cobimetinib	Cobimetinib (60 mg once a day) will be taken on days 1 - 21 of each 28-day treatment cycle.

Timeline

• Start date: 2018-07-01
• Primary completion: 2023-02-10
• Completion: 2023-02-10
• First posted: 2018-02-13
• Last updated: 2023-09-14

Locations

3 sites across 1 country: Germany