Single arm, open label, phase II trial of vemurafenib and cobimetinib in patients with advanced tumours harbouring BRAF V600 mutations detected by CGP (MoST 12).
The BRAFv600 ASPiRATION substudy intends to demonstrate activity of vemurafenib and cobimetinib in participants with BRAFv600+ metastatic NSCLC. Vemurafenib selectively inhibits mutated BRAF V600E kinase and cobimetinib is a MEK inhibitor. Vemurafenib and cobimetinib are used together in treatment by stopping cancer cells from growing and spreading. The drug combination is commonly used in melanoma.
Summary:
Single arm, open label, phase II trial of vemurafenib and cobimetinib in patients with advanced tumours harbouring BRAF V600 mutations detected by CGP (MoST 12).
Indication:
Patients with pathologically confirmed metastatic non-squamous NSCLC or other advanced cancers harbouring a BRAF V600 mutation detected by comprehensive genome profiling.
Intervention:
Patients will receive continuous vemurafenib 960 mg twice a day (from days 1 to 28 in a 28-day cycle) in combination with cobimetinib 60 mg daily (from days 1 to 21 in a 28-day cycle, followed by a 7-day break in cobimetinib treatment from days 22 to 28) until disease progression, participant withdrawal or unacceptable toxicity.
More information:
ASPiRATION substudies include NSCLC-specific substudies and Omico MoST substudies that cater for NSCLC patients with tumours expressing the appropriate molecular biomarkers. The ASPiRATION substudies are all Phase II single arm open label signal-seeking clinical trials with the intent to demonstrate or confirm drug activity and safety in order to inform subsequent randomised Phase III clinical trials.
The ASPiRATION study and substudies are led by TOGA, in collaboration with Omico (Australian Genomic Cancer Medicine Centre) and the NHMRC Clinical Trials Centre (CTC), University of Sydney.
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