1. SUB-TYPE OF MDS: MDS patients and Chronic Myelomonocytic leukaemia -2 patients who require first-line treatment
2. SEVERITY OF MDS: Intermediate, High or Very High Risk
3. NAME OF DRUG: Sabatolimab (MBG453)
4. Aims and benefits: MBG453 is an antibody that binds to a specific receptor on T-cells. In so doing, it abolishes the inhibitory effect that tumour cells have on T-cells and enhances the ability of the T-cells to destroy tumour cells. This Phase 3 trial seeks to determine the effectiveness of using MBG453 in combination with Azacitidine. It is a double-blind placebo controlled study. The main aim is to compare the overall survival with MBG453 plus Azacitidine versus placebo plus Azacitidine.
5. Primary outcome: To determine overall survival.
6. Secondary outcome: Assessment of the effects on quality of life, red cell transfusion-free intervals and time to disease progression.

1. Basic inclusion criteria:
   • Intermediate, High or Very High Risk Myelodysplastic Syndrome based on the IPSS-R OR Morphologically confirmed Chronic Myelomonocytic leukaemia -2
   • Azacitidine is indicated
   • Not eligible for intensive chemotherapy
   • Not eligible for haemopoietic stem cell transplant
   • ECOG of ≤ 2
2. Basic exclusion criteria:
   • Prior therapy with immune checkpoint inhibitors
   • Previous first line treatment for Intermediate, High or Very High Risk Myelodysplastic Syndrome OR Chronic Myelomonocytic leukaemia -2
   • Diagnosis of acute myeloid leukaemia
   • Diagnosis of therapy related myeloid neoplasm
3. Trial sites/locations and name of physician in charge of trial (none are currently recruiting):
   • Novartis Investigative Site Edinburgh, United Kingdom, EH4 2XU
   • Novartis Investigative Site Nottingham, United Kingdom, NG5 1PB

If you think this information is relevant to you, please discuss it with your own physician