Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 70
Summary
- Conditions
- Bone Marrow Diseases
- Chronic Myelomonocytic Leukemia
- "Hematologic Diseases"
- Leukemia
- Leukemia, Myeloid
- Leukemia Myeloid Acute
- Myelodysplastic Syndromes
- Preleukemia
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study is comprised of six combination arms: Evaluation of a fixed dose of the standard of care agent decitabine, in combination with fixed dose PDR001 (Arm 1) Evaluation of a fixed dose of the standard of care agent decitabine in combination with escalating dose MBG453 (Arm 2) Evaluation of a fixed dose of the standard of care agent decitabine in combination with fixed dose of PDR001 and escalating dose of MBG453 (Arm 3) * Evaluation of an escalating dose of MBG453 (Arm 4) Evaluation of a fixed dose of PDR001 in combination with an escalating dose of MBG453 (Arm 5) Evaluation of a fixed dose of the standard of care agent azacitidine in combination with an escalating dose of MBG453 (Arm 6) The evaluation of decitabine with the combination of PDR001 and MBG453 (Arm 3) will start after Novartis and Investigator's review of the available safety and tolerability data from each of the first two cohorts in Arm 1 and Arm 2. Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03066648
- Collaborators
- Not Provided
- Investigators
- Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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