1. SUB-TYPE OF MDS:High risk MDS and AML, not suitable for induction chemotherapy or haemopoietic stem cell transplant
  2. SEVERITY OF MDS: High Risk MDS
  3. NAME OF DRUG: PDR001, MBG453, Decitabine
  4. Aims and benefits: PDR001 is a monoclonal antibody that functions to block the activity of PD-1 (programmed cell death protein 1) thus allowing T-cells to recognise and target cancer cells. MBG453 is a monoclonal antibody that binds to a specific protein found on the surface of T-cells thus allowing the T-cell to function normally against cancer cells by reducing tumour growth. This is a phase 1b study aimed at determining the safety and tolerability of the study drugs alone and in combination with decitabine. The study also aims to determine the recommended doses of each of these drugs.

  1. Primary outcome measures: 
    To establish the safety for the study drugs and determine the doses of the drugs that result in toxicities.
  2. Secondary outcome measures:
    To determine more information about how the drug works in the body including the rate at which the drug is spread throughout and removed from the bloodstream and also to establish response rates.
  3. Main basic exclusion criteria:
    The study has various treatment arms, each of which has specific inclusion criteria.

    • AML (de novo or relapsed/refractory) patients who are deemed unsuitable for standard induction chemotherapy or haemopoietic stem cell transplant.
    • AML patients who are suitable for decitabine therapy.
    • High risk MDS patients who are deemed unsuitable for standard induction chemotherapy or haemopoietic stem cell transplant.
    • High risk MDS patients who have failed hypomethylating agent therapy.
    • ECOG performance status of 0-2
  4. Basic exclusion criteria:
    • Patients who are suitable for standard induction chemotherapy or haemopoietic stem cell transplant and are willing to receive it.
  5. Trial sites/locations and name of physician in charge of trial:
    • - University Hospital of Wales, Cardiff

Please read information and always discuss trial information with your own physician.

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