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NCT02500797 · OUTCOME

Progression-free Survival (PFS)

Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery · Source last updated 2023-10-17

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
Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years

What was measured

Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir).

Groups in this outcome

Initial Single

Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

Initial Dual

Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

LPS Single

Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

LPS Dual

Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.

UPS/MFH Single

Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

UPS/MFH Dual

Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.

GIST Single

Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

GIST Dual

Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.

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

Analysis denominator · Participants

GroupSource count
Initial Single42
Initial Dual41
LPS Single15
LPS Dual14
UPS/MFH Single13
UPS/MFH Dual14
GIST Single10
GIST Dual11

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Initial Single1.7Not reported1.44.3Not reported
Initial Dual4.1Not reported2.64.7Not reported
LPS Single4.6Not reported3.2NAThe 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
LPS Dual5.5Not reported2.8NAThe 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
UPS/MFH Single1.5Not reported1.4NAThe 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
UPS/MFH Dual2.7Not reported1.5NAThe 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
GIST Single1.5Not reported1.310Not reported
GIST Dual2.9Not reported1.4NAThe 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        4.3
        value
        1.7
      2. group Id
        OG001
        lower Limit
        2.6
        upper Limit
        4.7
        value
        4.1
      3. comment
        The 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
        group Id
        OG002
        lower Limit
        3.2
        upper Limit
        NA
        value
        4.6
      4. comment
        The 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
        group Id
        OG003
        lower Limit
        2.8
        upper Limit
        NA
        value
        5.5
      5. comment
        The 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
        group Id
        OG004
        lower Limit
        1.4
        upper Limit
        NA
        value
        1.5
      6. comment
        The 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
        group Id
        OG005
        lower Limit
        1.5
        upper Limit
        NA
        value
        2.7
      7. group Id
        OG006
        lower Limit
        1.3
        upper Limit
        10
        value
        1.5
      8. comment
        The 95% Confidence Interval upper limit was not estimable (i.e. below the level of detection).
        group Id
        OG007
        lower Limit
        1.4
        upper Limit
        NA
        value
        2.9
denoms
  1. counts
    1. group Id
      OG000
      value
      42
    2. group Id
      OG001
      value
      41
    3. group Id
      OG002
      value
      15
    4. group Id
      OG003
      value
      14
    5. group Id
      OG004
      value
      13
    6. group Id
      OG005
      value
      14
    7. group Id
      OG006
      value
      10
    8. group Id
      OG007
      value
      11
    units
    Participants
description
Progression free survival (PFS) is defined as the time from the date of randomization to the date of disease progression or death resulting from any cause, whichever comes first. Progression (PD) is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator. (PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir).
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Initial Single
  2. description
    Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG001
    title
    Initial Dual
  3. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG002
    title
    LPS Single
  4. description
    Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    OG003
    title
    LPS Dual
  5. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG004
    title
    UPS/MFH Single
  6. description
    Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    OG005
    title
    UPS/MFH Dual
  7. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
    id
    OG006
    title
    GIST Single
  8. description
    Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
    id
    OG007
    title
    GIST Dual
param Type
MEDIAN
reporting Status
POSTED
time Frame
Time from randomization to first of either disease progression or death from any cause, assessed up to 3 years
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice