NCT02708641

A Phase II Study of Pembrolizumab as Post-Remission Treatment of Patients ≥ 60 With AML

A Phase II Study of Pembrolizumab as Post-Remission Treatment of Patients ≥ 60 With Acute Myeloid Leukemia (AML) Who Are Not Transplantation Candidates

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Michael Boyiadzis · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effect of pembrolizumab on the duration of remission in acute myeloid leukemia. Pembrolizumab is given after complete remission is obtained in those with AML at least 60 years old who are not candidates for allogeneic stem cell transplant. The primary purpose of this study is determine if the time to relapse can be extended. Additionally, the safety and tolerability of pembrolizumab will be closely monitored.

Detailed description

Patients \>60 years old with AML often have a dismal prognosis. Even though many of these patients are able to obtain a Complete Response to treatment, relapse occurs in the vast majority of patients. Transplants may reduce relapse rates in this population, but is only feasible in a minority of patients. AML's immunosuppressive microenvironment in general and PD-1/PD-L1 upregulation in particular appears to increase the risk of relapse. Importantly, PD-1 and its ligands are particularly increased after therapy compared to initial diagnosis. As such, PD-1 inhibition with pembrolizumab offers to limit leukemic cell immune escape, thereby allowing the patient's immune system to eradicate the submicroscopic residual disease and reducing relapse rates. Treatment for this study is 200 mg Q3W as an appropriate dose for the switch to fixed dosing is based on simulations performed using the population PK model of Pembrolizumab showing that the fixed dose of 200 mg every 3 weeks will provide exposures that 1) are optimally consistent with those obtained with the 2 mg/kg dose every 3 weeks, 2) will maintain individual patient exposures in the exposure range established in melanoma as associated with maximal efficacy response and 3) will maintain individual patients exposure in the exposure range established in melanoma that are well tolerated and safe.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	pembrolizumab	200 mg IV given every three weeks

Timeline

• Start date: 2016-10-04
• Primary completion: 2020-06-11
• Completion: 2020-12-01
• First posted: 2016-03-15
• Last updated: 2021-08-10
• Results posted: 2021-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study