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NCT02526017 · OUTCOME

Efficacy: Overall Survival (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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From first dose of study drug up to the end of study; maximum time on study in Phase 1b was 35.9 months.

What was measured

Overall survival (OS) was defined as the time from first dose of study drug to death due to any cause. OS was calculated using the Kaplan-Meier method. Participants who did not die while on study were censored on the date they were last known to be alive.

Analysis population: All treated participants in Phase 1b; Efficacy endpoints were specified to be analyzed by disease type for phase 1b participants only.

Groups in this outcome

Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)

Participants with NSCLC with no prior exposure to any PD-1 pathway targeting drug (PD-1 naïve) 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 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)

Participants with NSCLC with de novo or acquired resistance to an anti-PD-1 targeting drug (PD-1 resistant) 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 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN

Participants with SCCHN 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 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer

Participants with pancreatic cancer 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 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer

Participants with advanced ovarian cancer 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 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC

Participants with RCC 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 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM

Participants with malignant glioma 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 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma

Participants with melanoma 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 Q2W: NSCLC (PD-1 Naïve)30
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)31
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN30
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer68
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer31
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC30
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM30
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma11

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)12.3Not reported6.119.1Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)4.7Not reported2.610.3Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN6.4Not reported3.4NACould not be estimated due to the low number of events
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer5.6Not reported4.08.0Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer13.9Not reported6.916.4Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCCNANot reported16.8NACould not be estimated due to the low number of events
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM8.1Not reported5.712.8Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma5.3Not reported1.124.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.1
        upper Limit
        19.1
        value
        12.3
      2. group Id
        OG001
        lower Limit
        2.6
        upper Limit
        10.3
        value
        4.7
      3. comment
        Could not be estimated due to the low number of events
        group Id
        OG002
        lower Limit
        3.4
        upper Limit
        NA
        value
        6.4
      4. group Id
        OG003
        lower Limit
        4.0
        upper Limit
        8.0
        value
        5.6
      5. group Id
        OG004
        lower Limit
        6.9
        upper Limit
        16.4
        value
        13.9
      6. comment
        Could not be estimated due to the low number of events
        group Id
        OG005
        lower Limit
        16.8
        upper Limit
        NA
        value
        NA
      7. group Id
        OG006
        lower Limit
        5.7
        upper Limit
        12.8
        value
        8.1
      8. group Id
        OG007
        lower Limit
        1.1
        upper Limit
        24.8
        value
        5.3
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      31
    3. group Id
      OG002
      value
      30
    4. group Id
      OG003
      value
      68
    5. group Id
      OG004
      value
      31
    6. group Id
      OG005
      value
      30
    7. group Id
      OG006
      value
      30
    8. group Id
      OG007
      value
      11
    units
    Participants
description
Overall survival (OS) was defined as the time from first dose of study drug to death due to any cause. OS was calculated using the Kaplan-Meier method. Participants who did not die while on study were censored on the date they were last known to be alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with NSCLC with no prior exposure to any PD-1 pathway targeting drug (PD-1 naïve) 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: NSCLC (PD-1 Naïve)
  2. description
    Participants with NSCLC with de novo or acquired resistance to an anti-PD-1 targeting drug (PD-1 resistant) 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
    OG001
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)
  3. description
    Participants with SCCHN 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: SCCHN
  4. description
    Participants with pancreatic cancer 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
    OG003
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer
  5. description
    Participants with advanced ovarian cancer 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
    OG004
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer
  6. description
    Participants with RCC 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: RCC
  7. description
    Participants with malignant glioma 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
    OG006
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM
  8. description
    Participants with melanoma 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
    OG007
    title
    Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma
param Type
MEDIAN
population Description
All treated participants in Phase 1b; Efficacy endpoints were specified to be analyzed by disease type for phase 1b participants only.
reporting Status
POSTED
time Frame
From first dose of study drug up to the end of study; maximum time on study in Phase 1b was 35.9 months.
title
Efficacy: Overall Survival (Phase 1b)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice