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NCT03927105 · OUTCOME

Summarize Adverse Events

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
NUMBER
Unit
number of events
Interval / dispersion
Not reported
Time frame
From time of consent through 100 days post treatment discontinuation. Longest actual collection for AEs: 13 months. Average of 9.5 Months

What was measured

Assess and summarize adverse events (AEs) using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Groups in this outcome

Nivolumab + Cabiralizumab

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.

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

Grade 3 hypertension
Values in number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Cabiralizumab1Not reportedNot reportedNot reportedNot reported
Grade 3 mucositis oral
Values in number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Cabiralizumab1Not reportedNot reportedNot reportedNot reported
Grade 3 sepsis
Values in number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Cabiralizumab1Not reportedNot reportedNot reportedNot reported
Grade 3 adrenal insufficiency
Values in number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Cabiralizumab1Not reportedNot reportedNot reportedNot reported
Grade 3 endocarditis infective
Values in number of events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Nivolumab + Cabiralizumab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3 hypertension
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3 mucositis oral
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3 sepsis
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3 adrenal insufficiency
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Grade 3 endocarditis infective
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
Assess and summarize adverse events (AEs) using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.
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
    OG000
    title
    Nivolumab + Cabiralizumab
param Type
NUMBER
reporting Status
POSTED
time Frame
From time of consent through 100 days post treatment discontinuation. Longest actual collection for AEs: 13 months. Average of 9.5 Months
title
Summarize Adverse Events
type
SECONDARY
unit Of Measure
number of events

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

Preserved source evidence · Not medical advice