CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
vemurafenib and cobimetinibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02583516
NCT02583516Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of Vemurafenib Plus Cobimetinib Continuous Versus Intermittent, in Previously Untreated BRAFV600- Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

Grupo Español Multidisciplinar de Melanoma·interventional·Posted Oct 22, 2015·Updated Feb 17, 2020

In Brief

A Phase 2 clinical trial evaluating vemurafenib and cobimetinib for Melanoma. Completed, enrolled 70 participants across 18 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of two different schedules of administration of vemurafenib in combination with cobimetinib (continuous and intermittent) in previously untreated BRAFV600- mutation positive patients with unresectable locally advanced or metastatic melanoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesSpain
CollaboratorsRoche Farma, S.A, Pivotal S.L.

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 22, 2015
Enrollment StartJun 30, 2015
Primary CompletionSep 30, 2019
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 10.7 years ago

Interventions

vemurafenib and cobimetinibdrug

Comparison between different treatment regimens