A Study of Vemurafenib and GDC-0973 (Cobimetinib) in Participants With BRAFV600E Mutation-Positive Metastatic Melanoma
Status:
Completed
Trial end date:
2017-12-12
Target enrollment:
Participant gender:
Summary
This open-label, dose-escalation study of vemurafenib in combination with cobimetinib will
evaluate the safety, tolerability and pharmacokinetics in participants with BRAFV600
mutation-positive metastatic melanoma. Participants with previously untreated, BRAFV600E
mutation-positive, locally advanced/unresectable or metastatic melanoma or those who have
progressed on vemurafenib monotherapy immediately prior to enrolling in this trial are
eligible. Participants will be assigned to different cohorts with escalating oral doses of
vemurafenib and cobimetinib. This study consists of 2 stages, Stage 1 (Dose Escalation Stage
[DES] and Cohort Expansion Stage [CES]) and the anticipated time on study treatment is until
disease progression, unacceptable toxicity or any other discontinuation criterion is met.