Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

Condition

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myelodysplastic Syndromes

Preleukemia

Bone Marrow Diseases

Hematologic Diseases

Chronic Myelomonocytic Leukemia

Interventions

Drug:PDR001

Drug:MBG453

Drug:Azacitidine

Drug:Decitabine

ClinicalTrials.gov identifier

NCT03066648

Novartis reference number

CPDR001X2105

Phase

Phase 1

This study is Active, not recruiting.

Official title

Phase 1b, Multi-arm, Open-label Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Purpose

To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine or azacitidine in AML and intermediate or high- risk MDS patients, and to identify recommended doses for future studies.