drugset
drugset / Trial / NCT03514901

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.

NCT03514901 ↗

Phase 2 Unknown 120 enrolled Italian Melanoma Intergroup
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2018-06-18
Primary completion
2023-04-29
Completion
2023-04-29

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nivolumab Monoclonal antibody 3 mg/kg Intravenous
Comparator Pembrolizumab Monoclonal antibody 2 mg/kg Intravenous

Indications

metastatic melanoma