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Protocol No. NCI9706

Principal Investigator Mattison, Ryan

Phase II

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title Randomized phase II study to assess the role of Nivolumab as single agent to eliminate minimal residual disease and maintain remission in acute myelogenous leukemia (AML) patients after chemotherapy

Objective The purpose of this study is to compare good and bad effects of using the drug Nivolumab compared to the usual approach of being closely followed but no treatment. Nivolumab could prevent your leukemia from coming back but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach.

Treatment Nivolumab is an antibody (a human protein that sticks to a part of the tumor and/or immune cells) designed to allow the body's immune system to work against tumor cells. Nivolumab has been approved by the US Food and Drug Administration (FDA) in certain instances for the treatment of melanoma, non-small cell lung cancer and renal cancer. However the use of Nivolumab for the treatment of AML is experimental.

Description A computer will by chance assign you to treatment groups in the study. This is called randomization. This study has two study groups. Group 1 will receive the study drug, Nivolumab, and Group 2 will not receive any treatment. If you are in Group I you will receive the study drug, Nivolumab in your vein every 2 weeks for 46 doses or until your AML relapses. If you are in the no treatment group, you will be monitored monthly for one year, then every 2 months for another year. If your leukemia comes back, you will have the option to be treated with Nivolumab every 2 weeks for 46 doses. For both groups research blood samples will be collected at 2, 3, 6, and 12 months on the study, and when you come off the study due to disease coming back or completion of the study. Both groups will have research bone marrow biopsy/aspiration samples obtained at 3 months, 6 months, and 12 months on the study, and anytime your doctor will see any change of your blood to indicate possible disease coming back.

Key Eligibility
  • AML patients in first clinical complete remission.
  • Confirmed remission must be within 60 days after bone marrow biopsy from their last course of chemotherapy.
  • Patient is not a candidate for stem cell transplant due to advanced age or co-morbidities; or the enrollee does not have donor available; or the enrollee declines stem cell transplant due to personal belief; or stem cell transplant is not standard of care based on the risk category of disease.
  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study are not eligible.
  • Patients should be excluded if they have had prior treatment with an anti-PD-1, anti-PDL1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • Patients with known CNS involvement may be excluded,however, if CNS disease is cleared before the treatment with Nivolumab, patients could be allowed if no permanent CNS damage.
  • Pregnant women are excluded from this study.

Applicable Disease Sites Leukemia

Therapies Involved Immunotherapy

Drugs Involved BMS-936558 (Nivolumab); Nivolumab; Opdivo (Nivolumab)

Status Open

Participating Institutions UW Hospital and Clinics