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Single arm, open label, signal seeking, phase II trial of the activity of Palbociclib in combination with Avelumab in patients with tumours with amplified D-type cyclins or CDK4/6 or inactivation of CDKN2A.
Australian Genomic Cancer Medicine Centre (AGCMC)
Other Non-Commercial Sponsor
University of Sydney
This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437). This is an open-label trial for patients with solid cancers with amplified D-type cyclins or CDK4/5 or inactivation of CDKN2A. All participants will receive Palbociclib first on its own in the first cycle of treatment. Palbociclib will be administered orally at a dose of 125mg once daily for 21 days, followed by 7 days of washout. This dosage may be reduced if participants experiences intolerance toxicity. Avelumab will be administered intravenously at a dose of 10mg/kg every 2 weeks, starting from the second cycle of treatment. Both drugs will be administered continuously until disease progression is documented or when the participant experiences intolerable toxicity or withdraws for another reason.