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Recruitment on holdLast updated: 29 August 2023

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.

Clinical summary

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.

Conditions

This trial is treating patients with solid cancers.

Cancer

Advanced Cancers Advanced

Age

People18+

Phase

II

Trial Acronym

MoST 10 (substudies 23-24)

More information

Trial Identifiers

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Commercial Sponsor

University of Sydney, Australian Genomic Cancer Medicine Centre (AGCMC)

Scientific Title

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.

Eligibility

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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