drugset / Trial / NCT02892318

A Study Evaluating the Safety and Pharmacology of Atezolizumab Administered in Combination With Immunomodulatory Agents in Participants With Acute Myeloid Leukemia (AML)

NCT02892318

Phase 1 Completed 40 enrolled Hoffmann-La Roche
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a non-randomized, open-label, Phase Ib study of atezolizumab in combination with immunomodulatory agents for the treatment of participants with AML (relapsed/refractory and treatment-naive, elderly participants unfit for induction chemotherapy). The study has been designed with the intent, over time, to study multiple combinations of atezolizumab with different immunomodulatory agents in participants with AML. The study will begin with the evaluation of the combination of atezolizumab and guadecitabine (Arm A). In the future, additional arms may be added.

Timeline

Start
2016-10-31
Primary completion
2019-12-12
Completion
2019-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 840 mg Intravenous
Subject Guadecitabine Oligonucleotide (other) 60 mg/m2 Subcutaneous