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NCT02526017 · OUTCOME

Safety: Number of Participants With Treatment Discontinuations, Modifications, or Interruptions Due to Adverse Events (Phase 1b)

Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers · Source last updated 2022-03-09

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
From first dose of study drug up to last dose; median (range) duration of exposure was 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab.

What was measured

Safety: In the Phase 1b only, the incidence of treatment discontinuations, modifications, and interruptions due to adverse events.

Analysis population: All participants who received at least 1 dose of cabiralizumab and/or nivolumab at the RD of 4 mg/kg cabiralizumab + 3 mg/kg nivolumab.

Groups in this outcome

Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W

Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.

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

Analysis denominator · Participants

GroupSource count
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W265

Reported measurements

Cabiralizumab infusion interruptions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab infusion modifications
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W12Not reportedNot reportedNot reportedNot reported
Nivolumab infusion interruptions
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W4Not reportedNot reportedNot reportedNot reported
Nivolumab infusion modifications
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W8Not reportedNot reportedNot reportedNot reported
AEs leading to discontinuation of cabiralizumab or nivolumab
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W54Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Cabiralizumab infusion interruptions
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
    title
    Cabiralizumab infusion modifications
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Nivolumab infusion interruptions
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Nivolumab infusion modifications
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        54
    title
    AEs leading to discontinuation of cabiralizumab or nivolumab
denoms
  1. counts
    1. group Id
      OG000
      value
      265
    units
    Participants
description
Safety: In the Phase 1b only, the incidence of treatment discontinuations, modifications, and interruptions due to adverse events.
groups
  1. description
    Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    OG000
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least 1 dose of cabiralizumab and/or nivolumab at the RD of 4 mg/kg cabiralizumab + 3 mg/kg nivolumab.
reporting Status
POSTED
time Frame
From first dose of study drug up to last dose; median (range) duration of exposure was 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab.
title
Safety: Number of Participants With Treatment Discontinuations, Modifications, or Interruptions Due to Adverse Events (Phase 1b)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice