Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02117219 | Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome | PHASE1 | COMPLETED | 67 | — | — | May 20, 2014 | Apr 30, 2019 | May 10, 2019 | 21 | United States, France +2 |
DLT (MEDI4736 monotherapy only) assessment will be done by reviewing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. For monotherapy or combo w/aza AEs, SAEs, lab evaluations, vital signs, physical exams, ECGs will be done.
Overall safety assessments will be done by reviewing adverse events (AEs, serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations and electrocardiogram (ECG) results.
| Arm | Type | Description |
|---|---|---|
| MEDI4736 Evaluate MEDI4736 in MDS | EXPERIMENTAL | Evaluate MEDI4736 monotherapy and MEDI4736 in combination with azacitidine after monotherapy progression in MDS |
| MEDI4736 + tremelimumab | EXPERIMENTAL | Evaluate MEDI4736 in combination with tremelimumab |
| MEDI4736 + tremelimumab + azacitidine | EXPERIMENTAL | Evaluate MEDI4736 in combination with tremelimumab and azacitidine |
| Name | Type | Description |
|---|---|---|
| MEDI4736 Evaluate MEDI4736 in MDS | BIOLOGICAL | MEDI4736 will be administered by IV infusion |
| VIDAZA | DRUG | VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy |
| tremelimumab | BIOLOGICAL | tremelimumab will be administered by IV infusion |
Inclusion Criteria: Adult male or female subjects with pathologically confirmed MDS who failed to respond, relapsed after an initial response, or were unable to tolerate hypomethylating agents, ECOG performance status of 0 - 2, and adequate organ and marrow function. Exclusion Criteria: Concurren...