MedTrace Logo

Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation

NCT01959633 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-02-24

No results posted yet for this study

Summary

The hypothesis of this study is to evaluate the safety and the efficacy of Vemurafenib/PEG-interferon combination and the IFNAR1 upregulation lead by this treatment.

Conditions

Interventions

DRUG

Vemurafenib

Vemurafenib 960 mg b.i.d. for each course of treatment lasting 28 days

DRUG

Peg-interferon

In the Phase I are included 3 cohorts. Cohort 1) Peg-interferon 1 µg/Kg one time per week s.c. Cohort 2) Peg-interferon 2 µg/Kg one time per week s.c. Cohort 3) Peg-interferon 3 µg/Kg one time per week s.c. Interferon treatment should start after 15 days of Vemurafenib only In the Phase II is included the cohort selected by phase I due to MTD and expanded at RD.

DRUG

Cobimetinib

Cobimetinib 60 mg o.d. (21 days on followed by 7 days off)

Sponsors & Collaborators

  • Fondazione Melanoma Onlus

    lead OTHER

Principal Investigators

  • Paolo A Ascierto, MD · Fondazione Melanoma Onlus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-03
Primary Completion
2018-03-26
Completion
2018-03-26

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 NCT01959633 on ClinicalTrials.gov