Phase 1 Study to Evaluate the Safety and Tolerability of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with Myelodysplastic Syndrome after Treatment with Hypomethylating Agents
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Safety and Tolerability of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with Myelodysplastic Syndrome after Treatment with Hypomethylating Agents.
IRAS ID
152182
Contact name
Timothy Chevassut
Contact email
Sponsor organisation
MedImmune LLC
Eudract number
2014-000577-39
Clinicaltrials.gov Identifier
Research summary
This is a phase 1 study to evaluate the safety and tolerability of MEDI4736 in patients with Myelodysplastic Syndrome
after treatment with hypomethylating agents.
Myelodysplastic Syndrome (MDS) is a disorder with an abnormality in the bone marrow resulting in reduced levels of
healthy blood cells. About one quarter of patients develop acute myeloid leukaemia (AML). Median survival rates for
patients following initial diagnosis range from approximately 5 years to 5 months depending on type and severity (riskcategory)
of the disease.
Patients who have failed hypomethylating therapy, a form of chemotherapy, have a very poor overall survival rate.
Treatment options are limited and the majority of patients go on to supportive care i.e. not treating the underlying
disease but rather control symptoms and complications caused by the disease.
Doctors diagnose about 2,000 new cases of MDS each year in the United Kingdom alone. The incidence is probably
increasing as the age of the population increases.
The purpose of this study is to evaluate the safety, tolerability, and antitumour
activity of MEDI4736 in adults with MDS
after prior treatment with hypomethylating agents. It is hoped that MEDI4736, a human antibody, may result in clinical
benefit to people with MDS.
The study has been designed to have two phases with two cohorts each (low / intermediate1
and intermediate2
/
high risk group). This allows MEDI4736 to be studied to see how effective it is in regards to the severities of MDS.
The first phase (doseescalation)
will determine the right dose of MEDI4736 to be safe and tolerable in MDS patients.
Once a suitable dose is found, the second phase (doseexpansion)
determines how effective MEDI4736 is in MDS
sufferers. Enrolment could reach up to a total of 70 participants in the entire study which is conducted at approximately
420
study centres globally.REC name
London - Hampstead Research Ethics Committee
REC reference
14/LO/0892
Date of REC Opinion
4 Jul 2014
REC opinion
Further Information Favourable Opinion