Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant

Lymphoma Clinical Trial

Official title: Phase 1 Study of Nivolumab in Combination With Tocilizumab for Treatment of Patients With Relapsed Hematological Malignancies Post-allogeneic Transplant

Status Terminated

Clinical Trial Summary

This is a phase 1, interventional single arm, open label, treatment study designed to evaluate the safety combination programmed cell death protein 1 (PD-1) and interleukin 6 (IL-6) inhibition in participants with relapsed disease post-allogeneic transplant.

Clinical Trial Description

Study disease: Hematologic malignancies including, but not exclusive to,acute/chronic leukemia, lymphoma, and myelodysplastic syndrome that has relapsed after allogeneic transplant.

Study Rationale: Phase 1 Safety/Dose Finding Study: To determine the safety and maximum tolerated dose of Nivolumab in combination with Tocilizumab.

Study Agent Description:

Tocilizumab is a monoclonal antibody and immunosuppressant; specifically, tocilizumab is an IL-6 receptor antagonist.

Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor of T cells blocking its interaction with PD-L1 and PD-L2, thereby enhancing T-cell proliferation and allowing the immune system to attack the tumor.

Number of Subjects: A maximum of 12 participants will be enrolled on this Phase 1 study.

Duration of Follow-up: Participants will be followed for up to one year post-treatment for survival and response.

Study Design: This is a 3 + 3 design. In a "3 + 3 design," three participants are initially enrolled into a given dose cohort. If there is no dose limiting toxicity (DLT) observed in any of these subjects, the trial proceeds to enroll additional subjects into the next higher dose cohort. If one subject develops a DLT at a specific dose, an additional three subjects are enrolled into that same dose cohort. Development of DLTs in more than one of six subjects in a specific dose cohort suggests that the maximum tolerated dose (MTD) has been exceeded, and further dose escalation is not pursued. ;

Related Conditions & MeSH terms

• Acute Leukemia
• Chronic Leukemia
• Hematologic Neoplasms
• Leukemia
• Lymphoma
• Myelodysplastic Syndromes

• NCT number: NCT03588936
• Study type: Interventional
• Source: Medical College of Wisconsin
• Status: Terminated
• Phase: Phase 1
• Start date: September 14, 2018
• Completion date: July 15, 2020