NCT02985554

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

Phase I Study to Assess the Tolerability and Efficacy of Nivolumab as Single Agent to Eliminate Minimal Residual Disease and Maintain Remission in Patients With Hematologic Malignancies After Allogeneic Stem Cell Transplantation

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Nivolumab will be administrated intravenously. Standard dose escalation will be used for the intensification phase with starting dose at 1m/kg every 2 weeks for 4 doses. The DLT observation period is 29 days starting with the first dose taken on Day 1, The study treatment will continue until one of the discontinuation criteria is met. Each dose level (1-2) will be tested using the 3+3 design. If level 2 of 3mg/kg is reached without DLTs, 3mg/kg will be used for the dose expansion cohort. After the intensification phase, patients will start Nivolumab every 12 weeks maintenance phase till 2 years post allo-SCT. Patients will also receive best supportive care (BSC), including blood product transfusions, antimicrobials, and (as appropriate) granulocyte colony stimulating factors for neutropenic infection or poor graft function.

Conditions

• Hematologic Malignancies

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab dose escalation will be used for the intensification phase with starting dose at 1m/kg every 2 weeks for 4 doses.

Timeline

• Start date: 2017-03-20
• Primary completion: 2019-02-06
• Completion: 2020-06-22
• First posted: 2016-12-07
• Last updated: 2020-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study