drugset / Trial / NCT02645149

Molecular Profiling and Matched Targeted Therapy for Patients With Unresectable Advanced or Metastatic Melanoma

NCT02645149

Phase 2 Completed 216 enrolled Melanoma Institute Australia Novartis · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a patient oriented translational research project aiming to improve clinical outcomes for patients with BRAF and NRAS wild-type unresectable Stage III or Stage IV metastatic melanoma who have progressed on, or are unable to receive standard therapy (in general, immunotherapy). Consecutive patients seen at three major clinics and fitting the broad eligibility criteria will be invited to participate. The approach is designed to test the impact of different targeted drugs on different mutations in a single type of cancer. In this project, patients will have tumour tissue genetically profiled to determine which mutation(s) are present, and will then be assigned to receive a matched drug expected to target the mutation(s) in the tumour. Where multiple targets are identified in one patient, or where multiple potential therapies would be appropriate for a single tumour mutation, the treating clinician may determine the appropriate therapeutic approach after consultation with the study team, using the latest version of library of matched therapies.

Timeline

Start
2021-11-22
Primary completion
2025-11-01
Completion
2026-03-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ceritinib Small molecule
Subject Pazopanib Small molecule
Subject Ribociclib Small molecule
Subject Trametinib Small molecule

Indications