1. SUB-TYPE OF MDS: All patients who failed to respond to azacitidine or decitabine(SCT) -
2. SEVERITY OF MDS: Intermediate –2 or High Risk -
3. NAME OF DRUG: Oral Azacitidine plus Durvalumab, which activates the immune system to create a response against cancer/tumor cells
4. Aims and benefits: This is a phase 2 international study for patients with myelodysplastic syndromes who fail to achieve an objective response to treatment with azacitidine (injection) or decitabine. Durvalumab is an antibody which works against a specific cell death (PD-L1) which activates the immune system to have a response against tumor cells expressing PD-L1.
   (Monoclonal antibody directed against programmed cell death-1 ligand 1 (PD-L1) which activates the immune system to exert a response against tumor cells expressing PD-L1.
   The study aims to determine the efficacy and safety of oral Azacitidine alone and in combination with Durvalumab.
   Primary outcome:
   • Overall response rate
   Secondary outcome:
   • Overall survival, time to onset of response, duration of response, stabilization of progressive disease, time to AML progression, adverse events
5. Basic inclusion criteria:
   • ≥ 18 years of age
   • Adequate course of treatment with either azacitidine (injection) or decitabine as the last therapeutic intervention for MDS prior to beginning screening for this study.
   • Disease progression or stable disease as best response to treatment
   • ECOG performance status of 0, 1 or 2
6. Basic exclusion criteria:
   • Rapidly-progressing MDS
   • Acute myeloid leukaemia
   • Prior allogeneic or autologous stem cell transplant
   • Prior exposure to the investigational oral formulation of decitabine, or other oral azacitidine derivative
   • Prior or ongoing response to treatment with azacitidine (injection) or decitabine, including relapsed disease
   • Significant liver or kidney impairment
   • Absolute white cell count (WCC) of ≥ 20 x 109/L
   • Patients with active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease active within the last 6 months or other serious gastrointestinal chronic conditions associated with diarrhoea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment.
7. Trial sites/locations and name of physician in charge of trial: United Lincolnshire Hospitals NHS Trust, Boston; Saint James University Hospital, Leeds; King's College Hospital School of Medicine, London; Hammersmith Hospital, London; University College Hospital , London; Northwick Park Hospital, Middlesex; Great Western Hospital, Oxford; Southampton General Hospital, Southampton
8. More information:

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