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NCT02526017 · OUTCOME

Efficacy: Overall Survival (OS) at One Year (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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
52 weeks

What was measured

Overall survival at one-year is defined as the percentage of participants who were alive one year after receiving their first dose of study drug.

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Naïve)51.1Not reported31.767.6Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: NSCLC (PD-1 Resistant)29.2Not reported13.746.6Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: SCCHN42.5Not reported23.060.7Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Pancreatic Cancer27.2Not reported15.839.9Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Ovarian Cancer52.9Not reported30.671.0Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: RCC77.8Not reported57.189.3Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: GBM35.0Not reported16.254.6Not reported
Cabiralizumab 4 mg/kg + Nivolumab 3 mg/kg Q2W: Melanoma36.4Not reported9.065.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.7
        upper Limit
        67.6
        value
        51.1
      2. group Id
        OG001
        lower Limit
        13.7
        upper Limit
        46.6
        value
        29.2
      3. group Id
        OG002
        lower Limit
        23.0
        upper Limit
        60.7
        value
        42.5
      4. group Id
        OG003
        lower Limit
        15.8
        upper Limit
        39.9
        value
        27.2
      5. group Id
        OG004
        lower Limit
        30.6
        upper Limit
        71.0
        value
        52.9
      6. group Id
        OG005
        lower Limit
        57.1
        upper Limit
        89.3
        value
        77.8
      7. group Id
        OG006
        lower Limit
        16.2
        upper Limit
        54.6
        value
        35.0
      8. group Id
        OG007
        lower Limit
        9.0
        upper Limit
        65.4
        value
        36.4
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 at one-year is defined as the percentage of participants who were alive one year after receiving their first dose of study drug.
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
NUMBER
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
52 weeks
title
Efficacy: Overall Survival (OS) at One Year (Phase 1b)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice