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Proposal 1599

Title of the Proposed Research

Predictors of exposure, adverse and therapeutic effects of BRAF/MEK inhibitors in advanced melanoma.

Lead Researcher

Michael Sorich

Affiliation

Flinders University

Funding Source

Supported by a project grant from the Australian National Health and Medical Research Council.

Potential Conflicts of Interest

None

Data Sharing Agreement Date

17 November 2016

Lay Summary

Advanced melanoma is a cancer that is difficult to treat. There have been a number of important advancements in the treatment of advanced melanoma in the last five years including the introduction of two classes of cancer medicines called BRAF inhibitors and MEK inhibitors which can be used individually or in combination. Even though these medicines are targeted to melanoma cancer cells, these medicines also cause a wide array of adverse events that can impact quality of life and limit treatment. To date there has been little research aiming to predict the patients who will be at greatest risk of adverse effects or most likely to benefit from treatment for these new cancer medicines.

This project seeks to enable improved prediction of the therapeutic and adverse outcomes of patients using these cancers medicines for the treatment of advanced melanoma. Being able to identify the expected prognosis and adverse effects may enable patients and clinicians to make better decisions regarding whether to commence, continue/switch or change dosing of these classes of cancer drugs.

Data from patients using a BRAF inhibitor and/or a MEK inhibitor for advanced melanoma in clinical trials will be analysed to identify patient characteristics, laboratory and clinical factors that are predictive of the most important adverse effects, and the therapeutic outcomes such as tumor shrinkage and survival.

Study Data Provided

ROCHE-NO25026 (BRIM3):A randomized, open-label, controlled, multicenter, global study on progression-free and overall survival in previously untreated patients with unresectable stage IIIC or stage IV melanoma with V600E BRAF mutation receiving RO5185426 or dacarbazine
ROCHE-NP22657 (BRIM2): An open-label multicenter study on the efficacy of continuous oral dosing of RO5185426 on tumour response in previously treated patients with metastatic
ROCHE-GO28141: A Phase III Double-blind, Placebo-controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.