MedTrace Logo

Clinical Trial to Evaluate the Efficacy of Vemurafenib in Combination With Cobimetinib (Continuous and Intermittent) in BRAFV600-mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

NCT02583516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-02-17

No results posted yet for this study

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.

Conditions

Interventions

DRUG

vemurafenib and cobimetinib

Comparison between different treatment regimens

Sponsors & Collaborators

  • Roche Farma, S.A

    collaborator INDUSTRY

  • Pivotal S.L.

    collaborator INDUSTRY

  • Grupo Español Multidisciplinar de Melanoma

    lead OTHER

Principal Investigators

  • José Antonio López-Martín, MD, PhD · Hospital Universitario 12 de Octubre

  • Alfonso Berrocal, MD, PhD · Hospital General Universitario de Valencia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02583516 on ClinicalTrials.gov