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Vemurafenib Plus Cobimetinib in Advanced or Metastatic Melanoma Patients

NCT03224208 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-04-26

No results posted yet for this study

Summary

In the BRIM-3 trial, which was conducted in patients with previously untreated advanced melanoma harboring the BRAF V600E mutation, vemurafenib, a potent inhibitor of mutated BRAF, was associated with prolonged overall survival (OS) and progression-free survival (PFS) compared to dacarbazine. In the same setting, combined use of vemurafenib and cobimetinib, a selective inhibitor of MEK, yielded a significant improvement in PFS and response rate, compared to vemurafenib monotherapy, along with an advantage in OS, which did not cross the pre-specified significance bounderies (COBRIM trial). In treatment-naïve patients with mutated BRAF, both anti PD-1-based immunotherapy and BRAF-targeted agents are feasible therapeutic options, with the former and latter agents being associated with more durable and earlier responses, respectively.

As suggested by National Comprehensive Cancer Network (NCCN) guidelines, the use of combined BRAF and MEK inhibitors in patients with progressive disease after immunotherapy, is also feasible, but it is not supported by category 1 evidence, in view of the lack of studies conducted in this setting.

The main objective of this phase II trial is to evaluate the efficacy and safety of the combined use of vemurafenib plus cobimetinib in advanced melanoma patients who have received first-line systemic immunotherapy for inoperable locally advanced / metastatic disease.

Conditions

  • Melanoma
  • Melanoma (Skin)
  • Melanoma Stage

Interventions

DRUG

Vemurafenib

Vemurafenib will be orally adminitered at 960 mg b.i.d. on Days 1-28

DRUG

Cobimetinib

Cobimetinib will be given orally at 60 mg qd on Days 1-21 of each 28-day treatment cycle

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Fondazione Melanoma Onlus

    lead OTHER

Principal Investigators

  • Paolo Antonio Ascierto · IRCCS Fondazione Pascale Naploli

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2020-09-12
Completion
2021-01-08

Countries

  • Italy

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 NCT03224208 on ClinicalTrials.gov