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NCT03927105 · FLOW

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Nivolumab and the Antagonistic CSF-1R Monoclonal Antibody Cabiralizumab (BMS-986227) in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma · Source last updated 2026-05-07

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    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 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.
    id
    FG000
    title
    Nivolumab + Cabiralizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      In observation for potential re-treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Subject was never treated due to new medical problems causing ineligibility prior to treatment.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Began Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Follow-up
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      comment
      completed through primary outcome measure collection; two participants are still in observation for secondary outcome measure assessments (not yet completed).
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
One participant consented, was deemed eligible, and enrolled to the trial, however subject was never treated due to new medical problems causing ineligibility prior to treatment.
Complete source fields
groups
  1. description
    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 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.
    id
    FG000
    title
    Nivolumab + Cabiralizumab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      In observation for potential re-treatment
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Subject was never treated due to new medical problems causing ineligibility prior to treatment.
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Began Treatment
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      Follow-up
    4. achievements
      1. group Id
        FG000
        num Subjects
        0
      comment
      completed through primary outcome measure collection; two participants are still in observation for secondary outcome measure assessments (not yet completed).
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        4
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
One participant consented, was deemed eligible, and enrolled to the trial, however subject was never treated due to new medical problems causing ineligibility prior to treatment.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice