- SUB-TYPE OF MDS: Patients who have previously received a hypomethylating agent (eg. Azacitidine, Decitabine)
- SEVERITY OF MDS: Intermediate-2 or High risk
- NAME OF DRUG: Durvalumab, Tremelimumab, Azacitidine
- Aims and benefits: This is a Phase 1 study for patients who have previously received a hypomethylating agent. Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1) which activates the immune system to exert a response against tumour cells expressing PD-L1. Tremelimumab is a monoclonal antibody that stimulates the immune system to attack tumour cells. It does this by switching off the inhibitory mechanisms that stop tumour cells from being destroyed. This study aims to determine the safety and tolerability of MEDI4736 as Monotherapy or in Combination With Tremelimumab With or Without Azacitidine.
- Primary outcome measures:
Assessing safety of the study drug
- Secondary outcome measures:
Determining response to treatment including improvement in transfusion requirements, progression-free and overall survival.
- Main basic inclusion criteria:
- Patients who have failed to respond, relapsed after an initial response, or were unable to tolerate hypomethylating agents, ECOG performance status of 0 – 2
- Main basic exclusion criteria:
- Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, prior monoclonal antibody against the same targets as the study drugs, alllogeneic or haploidentical transplant, current immunosuppressive medication or autoimmune or inflammatory disease.
- Trial sites/locations and name of physician in charge of trial:
Kings College Hospital, Brighton
- More information:https://clinicaltrials.gov/ct2/show/NCT01693562
Please read information and always discuss trial information with your own physician.