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NCT02526017 · OUTCOME

Immunogenicity of Nivolumab: Number of Participants With Anti-Nivolumab Antibodies (Phase 1a and 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
Blood samples were collected before the infusion on Cycles 1 (Baseline), 2, 3, 4, 5, 9, 13, and 21, and at 28 days and 100 days after the end of treatment

What was measured

Anti-drug antibodies (ADA) to nivolumab in serum were measured by a validated electrochemiluminescence assay. Baseline ADA Positive is defined as participants who had a baseline ADA sample which tested as positive for an anti-drug antibody against cabiralizumab; Post baseline ADA Positive is defined as participants that either had 1) an ADA detected (positive seroconversion) sample in a participant for whom ADA was not detected at baseline, or (2) an ADA detected sample with ADA titer at least 4-fold or greater than the baseline positive titer; Post baseline ADA Negative: Participants who never reported an ADA-positive sample after the initiation of treatment.

Analysis population: All participants who received at least 1 dose of nivolumab and had available ADA data at baseline and post-baseline.

Groups in this outcome

Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W

Participants received 1 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.

Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W

Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.

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.

Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W

Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.

Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W

Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) 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 1mg/kg + Nivolumab 3 mg/kg Q2W4
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W261
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W10

Reported measurements

Baseline nivolumab ADA-positive

Analysis denominator · Participants

GroupSource count
Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W4
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W261
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W10
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W26Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W2Not reportedNot reportedNot reportedNot reported
Baseline nivolumab ADA-negative

Analysis denominator · Participants

GroupSource count
Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W4
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W261
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W10
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W4Not reportedNot reportedNot reportedNot reported
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W3Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W235Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W6Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W8Not reportedNot reportedNot reportedNot reported
Nivolumab ADA-positive

Analysis denominator · Participants

GroupSource count
Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W249
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W0Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W57Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W3Not reportedNot reportedNot reportedNot reported
Nivolumab ADA-negative

Analysis denominator · Participants

GroupSource count
Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W249
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W9
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 1mg/kg + Nivolumab 3 mg/kg Q2W2Not reportedNot reportedNot reportedNot reported
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W3Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W192Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W5Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        26
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        261
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        10
      units
      Participants
    title
    Baseline nivolumab ADA-positive
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        235
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        8
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        261
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        10
      units
      Participants
    title
    Baseline nivolumab ADA-negative
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        57
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        3
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        249
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        9
      units
      Participants
    title
    Nivolumab ADA-positive
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        192
      4. group Id
        OG003
        value
        5
      5. group Id
        OG004
        value
        6
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        249
      4. group Id
        OG003
        value
        6
      5. group Id
        OG004
        value
        9
      units
      Participants
    title
    Nivolumab ADA-negative
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      261
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      10
    units
    Participants
description
Anti-drug antibodies (ADA) to nivolumab in serum were measured by a validated electrochemiluminescence assay. Baseline ADA Positive is defined as participants who had a baseline ADA sample which tested as positive for an anti-drug antibody against cabiralizumab; Post baseline ADA Positive is defined as participants that either had 1) an ADA detected (positive seroconversion) sample in a participant for whom ADA was not detected at baseline, or (2) an ADA detected sample with ADA titer at least 4-fold or greater than the baseline positive titer; Post baseline ADA Negative: Participants who never reported an ADA-positive sample after the initiation of treatment.
groups
  1. description
    Participants received 1 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 1mg/kg + Nivolumab 3 mg/kg Q2W
  2. description
    Participants received 2 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    OG001
    title
    Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W
  3. 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
    OG002
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
  4. description
    Participants received 6 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    OG003
    title
    Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W
  5. description
    Participants received 4 mg/kg cabiralizumab IV and 3 mg/kg nivolumab IV every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    OG004
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least 1 dose of nivolumab and had available ADA data at baseline and post-baseline.
reporting Status
POSTED
time Frame
Blood samples were collected before the infusion on Cycles 1 (Baseline), 2, 3, 4, 5, 9, 13, and 21, and at 28 days and 100 days after the end of treatment
title
Immunogenicity of Nivolumab: Number of Participants With Anti-Nivolumab Antibodies (Phase 1a and 1b)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice