NCT01959633View on ClinicalTrials.gov

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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

April 3, 2014

Primary Completion Date

March 26, 2018

Study Completion Date

March 26, 2018

Conditions
Melanoma
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)

Trial Locations (1)

80131

Fondazione G.Pascale, Napoli

All Listed Sponsors
lead

Fondazione Melanoma Onlus

OTHER

NCT01959633 - Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF Mutation | Biotech Hunter | Biotech Hunter