Full TitleGO30139: A Phase Ib Study Evaluating the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered in Combination with Immunomodulatory Agents in Patients with Acute Myeloid Leukemia
The purpose of this study is to assess the safety of a combination of two drugs, atezolizumab and guadecitabine, in patients with acute myeloid leukemia (AML) that continues to grow despite treatment and in older patients newly diagnosed with AML. Atezolizumab is a form of immunotherapy. It is designed to improve the immune system’s ability to recognize and destroy cancer cells by blocking PD-L1, a protein made by some cancers. Atezolizumab is approved for treating bladder and lung cancers; its use in this study is considered investigational.
Guadecitabine is similar to decitabine, another drug used to treat AML. It works by turning on certain genes that may be turned off in AML. It may also enhance the body’s immune response to cancer. Guadecitabine is given as a subcutaneous (under the skin) injection, and atezolizumab is given intravenously (by vein).
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have AML that has continued to grow despite prior treatment. Older patients (age 65+) with AML who have not yet been treated may also be eligible to participate.
- Patients must recover from the serious side effects of previous treatments before entering the study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.
For more information about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3849.