drugset / Trial / NCT02985554

Phase I Study to Assess the Tolerability and Efficacy of Nivolumab in Patients With Hematologic Malignancies

NCT02985554 ↗

Phase 1 Terminated 3 enrolled University of Chicago
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, dose escalation Phase I study to evaluate the tolerability and efficacy of single agent of Nivolumab as maintenance treatment to prevent relapse in patients with hematologic malignancies after allogeneic stem cell transplantation. Approximately 29 patients will be enrolled, where about 6-12 patients will be included on the dose escalation phase and 20 patients will be on the expansion cohort at maximal tolerated dose.

Timeline

Start
2017-03-20
Primary completion
2019-02-06
Completion
2020-06-22

Outcome

Outcome not reported

Stopped (Enrollment): “Study stopped early due to slow accrual and safety concerns.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Nivolumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 3 mg/kg Intravenous