- Name of trial drug: Oral Azacitidine plus Durvalumab, which activates the immune system to create a response against cancer/tumor cells
- For what level of MDS severity risk: Intermediate –2 or High Risk
- What subtype of MDS: Patients who failed to respond to azacitidine or decitabine(SCT)
- 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
- 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
- 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.
- 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
- More information:
Please read information and always discuss trial information with your own physician.