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NCT03927105 · OUTCOME

Overall Response at Four Months by (LUGANO 2014) Criteria

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.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
four months

What was measured

Overall response (CR + PR), as determined by LUGANO 2014 criteria (reported as number of participants with a CR or PR at 4 months). The Lugano classification is utilized for both lymphoma staging and response assessment and incorporates PET-CT imaging. Responses are described as either partial or complete, with a complete response requiring disappearance of metabolically active sites of disease.

Analysis population: All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated

Groups in this outcome

Nivolumab + Cabiralizumab

Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle. 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. Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Nivolumab + Cabiralizumab3

Reported measurements

Source class 1

Complete Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Cabiralizumab2Not reportedNot reportedNot reportedNot reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Cabiralizumab0Not reportedNot reportedNot reportedNot reported

Non-Responder

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Cabiralizumab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      title
      Complete Response
    2. measurements
      1. group Id
        OG000
        value
        0
      title
      Partial Response
    3. measurements
      1. group Id
        OG000
        value
        1
      title
      Non-Responder
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
Overall response (CR + PR), as determined by LUGANO 2014 criteria (reported as number of participants with a CR or PR at 4 months). The Lugano classification is utilized for both lymphoma staging and response assessment and incorporates PET-CT imaging. Responses are described as either partial or complete, with a complete response requiring disappearance of metabolically active sites of disease.
groups
  1. description
    Nivolumab 240mg IV + Cabiralizumab 4mg/kg on day 1 of every 14 day cycle. 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. Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms).
    id
    OG000
    title
    Nivolumab + Cabiralizumab
param Type
COUNT_OF_PARTICIPANTS
population Description
All subjects with measurable disease who received at least one cycle of treatment and had disease re-evaluated
reporting Status
POSTED
time Frame
four months
title
Overall Response at Four Months by (LUGANO 2014) Criteria
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice