Nivolumab and the Antagonistic CSF-1R Monoclonal Antibody Cabiralizumab (BMS-986227) in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan Rogel Cancer Center
Study ID
NCT03927105
Phase
PHASE2
Status
Completed

Conditions

  • Peripheral T Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 \[IgG4\]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. Nivolumab will be delivered intravenously at a fixed dose of 240 mg on day 1 of 14 day cycles.
  • cabiralizumab — DRUG
    Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms). Cabiralizumab will be delivered intravenously at a dosage of 4 mg/kg on day 1 of 14 day cycles.

Study Details

A multicenter trial evaluating the combination of nivolumab and the antagonistic CSF-1R monoclonal antibody cabiralizumab (BMS-986227) in patients with relapsed/refractory peripheral T cell lymphoma

Key Dates

Start date
Apr 25, 2019
Status verified
Apr 2026
Primary completion
Nov 1, 2019
Completion
Jul 6, 2023

Study Design

Enrollment
4 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + Cabiralizumab
    Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle.

Primary Outcome Measure

Overall Response Rate (ORR) at Four Months (LYRIC Criteria) [ Time Frame: 4 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Unviersity of WisconsinMadisonWisconsin53705-

Find similar trials in Ann Arbor, MI

By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MIOhio State University Comprehensive Cancer Center· Columbus, OHUnviersity of Wisconsin· Madison, WI

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