UnknownPhase 2

To Evaluate the Efficacy Beyond Progression of Vemurafenib+Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600+ Metastatic Melanoma in Focal Progression With First-line+Vemurafenib+Cobimetinib.

Italy120 participantsStarted 2018-06-18

Plain-language summary

The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Bilirubin ≤ 1.5 x the upper limit of normal (ULN).
✓. AST, ALT, and alkaline phosphatase ≤ 3 x ULN, with the following exceptions:
✓. Serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min based on measured CrCl from a 24-hour urine collection or Cockroft-Gault glomerular filtration rate estimation.

Exclusion criteria

✕. Current unstable angina.
✕. Symptomatic congestive heart failure of New York Heart Association class 2 or higher.
✕. History of congenital long QT syndrome or mean (average of triplicate measurements) QTcF ≥ 450 msec at baseline; presence of clinically significant ventricular or atrial dysrhythmias ≥ Grade 2.
✕. Uncontrolled hypertension ≥ Grade 2 (patients with a history hypertension controlled with anti-hypertensives to ≤ Grade 1 are eligible).
✕. Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower

What they're measuring

Overall Survival (OS) time for patients with focal progression

Timeframe: From date of randomization until the date of death from any cause, assessed up to 24 months

Trial details

NCT IDNCT03514901

SponsorIntergruppo Melanoma Italiano

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-29

View on ClinicalTrials.gov More Melanoma Metastatic trials