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

PHASE1CompletedINTERVENTIONAL
Enrollment

241

Participants

Timeline

Start Date

July 6, 2017

Primary Completion Date

September 8, 2023

Study Completion Date

September 8, 2023

Conditions
LeukemiaLeukemia, MyeloidLeukemia, Myeloid, AcuteMyelodysplastic SyndromesPreleukemiaBone Marrow DiseasesHematologic DiseasesChronic Myelomonocytic Leukemia
Interventions
DRUG

Decitabine

Decitabine is a cytidine deoxynucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation.

DRUG

PDR001

PDR001 is a high-affinity, ligand-blocking, humanized IgG4 monoclonal antibody directed against PD-1 that blocks the binding of PD-L1 and PD-L2.

DRUG

MBG453

MBG453 is a high-affinity, humanized anti-TIM-3 IgG4 monoclonal antibody which blocks the binding of TIM-3 to phosphatidylserine (PtdSer).

DRUG

Azacitidine

Azacitidine (5-azacytidine) is a cytidine nucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation

Trial Locations (11)

3004

Novartis Investigative Site, Melbourne

13273

Novartis Investigative Site, Marseille

77030

MD Anderson Cancer Center, Houston

97239

Oregon Health Sciences University Main Center, Portland

02114

Massachusetts General Hospital, Boston

FIN 00290

Novartis Investigative Site, Helsinki

01307

Novartis Investigative Site, Dresden

07740

Novartis Investigative Site, Jena

1081 HV

Novartis Investigative Site, Amsterdam

08036

Novartis Investigative Site, Barcelona

CF4 4XN

Novartis Investigative Site, Cardiff

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY