MoST 10 (substudies 23-24): This Phase II trial is evaluating how safe, tolerable and effective targeted therapy (palbociclib) is when combined with immunotherapy (avelumab) is in people with solid cancers with activating alterations in cell cycle genesSingle 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.

Summary

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.