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NCT02526017 · OUTCOME

Safety: Number of Participants With Adverse Events and Serious Adverse Events (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
From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.

What was measured

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation, patient-administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or causes prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Was an important medical event that may jeopardize the patient or may require intervention (e.g., medical, surgical) to prevent one of the other serious outcomes listed in the definition above.

Analysis population: All participants who received at least 1 dose of cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.

Groups in this outcome

Cabiralizumab 2 mg/kg Q2W

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

Cabiralizumab 4 mg/kg Q2W

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

Cabiralizumab 6 mg/kg Q2W

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

Cabiralizumab 1 mg/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 2 mg/kg Q2W3
Cabiralizumab 4 mg/kg Q2W10
Cabiralizumab 6 mg/kg Q2W11
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W4
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W3
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W265
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W6
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W10

Reported measurements

Any adverse event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 2 mg/kg Q2W2Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg Q2W10Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg Q2W10Not reportedNot reportedNot reportedNot reported
Cabiralizumab 1 mg/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 Q2W264Not 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 Q3W10Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cabiralizumab 2 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg Q2W6Not reportedNot reportedNot reportedNot reported
Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W2Not reportedNot reportedNot reportedNot reported
Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W1Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W138Not reportedNot reportedNot reportedNot reported
Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W3Not reportedNot reportedNot reportedNot reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q3W5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        10
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        264
      7. group Id
        OG006
        value
        6
      8. group Id
        OG007
        value
        10
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        138
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        5
    title
    Serious adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      11
    4. group Id
      OG003
      value
      4
    5. group Id
      OG004
      value
      3
    6. group Id
      OG005
      value
      265
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      10
    units
    Participants
description
An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation, patient-administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required inpatient hospitalization or causes prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Was an important medical event that may jeopardize the patient or may require intervention (e.g., medical, surgical) to prevent one of the other serious outcomes listed in the definition above.
groups
  1. description
    Participants received 2 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    OG000
    title
    Cabiralizumab 2 mg/kg Q2W
  2. description
    Participants received 4 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    OG001
    title
    Cabiralizumab 4 mg/kg Q2W
  3. description
    Participants received 6 mg/kg cabiralizumab IV Q2W until disease progression, unacceptable toxicity, or other reason for treatment discontinuation.
    id
    OG002
    title
    Cabiralizumab 6 mg/kg Q2W
  4. 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
    OG003
    title
    Cabiralizumab 1 mg/kg + Nivolumab 3 mg/kg Q2W
  5. 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
    OG004
    title
    Cabiralizumab 2 mg/kg + Nivolumab 3 mg/kg Q2W
  6. 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
    OG005
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W
  7. 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
    OG006
    title
    Cabiralizumab 6 mg/kg + Nivolumab 3 mg/kg Q2W
  8. 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
    OG007
    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 cabiralizumab and/or nivolumab. Safety results are grouped by participants who received the same treatment regimen.
reporting Status
POSTED
time Frame
From first dose of study drug up to 100 days after last dose. Median (range) duration of exposure was 6 (2-32) weeks in the monotherapy cohorts and 8 (2-108) weeks for cabiralizumab and 8 (2-156) weeks for nivolumab in the combination groups.
title
Safety: Number of Participants With Adverse Events and Serious Adverse Events (Phase 1a and 1b)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice