NCT03588936

Nivolumab and Tocilizumab for Relapsed Hematological Malignancy Post-allogeneic Transplant

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Acute Leukemia
• Chronic Leukemia
• Lymphoma
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Nivolumab (.25 mg/kg)	Participants will receive Nivolumab at one of two dose levels every 2 weeks for 4 treatments.
DRUG	Tocilizumab	Participants will receive 2 doses of tocilizumab
DRUG	Nivolumab (.5 mg/kg)	Participants will receive Nivolumab at one of two dose levels every 2 weeks for 4 treatments.

Timeline

• Start date: 2018-09-14
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2018-07-17
• Last updated: 2021-10-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study