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NCT02541604 · OUTCOME

PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) in Pediatric and Young Adult Participants With Solid Tumors · Source last updated 2020-02-25

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
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

Analysis population: Included safety-evaluable population, defined as patients who received any amount of study drug.

Groups in this outcome

Cohort 1

Participants with ewing sarcoma.

Cohort 5

Participants with non-rhabdomyosarcoma soft tissue sarcoma.

Cohort 6

Participants with osteosarcoma.

Cohort 7

Participants with rhabdomyosarcoma.

Cohort 8

Participants with wilms tumor.

Cohort 9

Participants with other tumor types with documented PD-L1 expression.

Cohort 10

Participants with other tumor types without documented PD-L1 expression.

Cohort 11

Participants with rhabdoid tumor.

Cohort 12

Participants with atypical teratoid rhabdoid tumor.

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

Analysis denominator · Participants

GroupSource count
Cohort 111
Cohort 510
Cohort 610
Cohort 710
Cohort 810
Cohort 94
Cohort 104
Cohort 112
Cohort 123

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 11.3Not reported0.61.4Not reported
Cohort 51.4Not reported1.33.7Not reported
Cohort 61.2Not reported0.91.8Not reported
Cohort 71.3Not reported1.11.8Not reported
Cohort 81.4Not reported1.12.8Not reported
Cohort 91.2Not reported0.71.3Not reported
Cohort 101.2Not reported1.110.1Not reported
Cohort 110.7Not reported0.31.1Not reported
Cohort 126.9Not reported1.79.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6
        upper Limit
        1.4
        value
        1.3
      2. group Id
        OG001
        lower Limit
        1.3
        upper Limit
        3.7
        value
        1.4
      3. group Id
        OG002
        lower Limit
        0.9
        upper Limit
        1.8
        value
        1.2
      4. group Id
        OG003
        lower Limit
        1.1
        upper Limit
        1.8
        value
        1.3
      5. group Id
        OG004
        lower Limit
        1.1
        upper Limit
        2.8
        value
        1.4
      6. group Id
        OG005
        lower Limit
        0.7
        upper Limit
        1.3
        value
        1.2
      7. group Id
        OG006
        lower Limit
        1.1
        upper Limit
        10.1
        value
        1.2
      8. group Id
        OG007
        lower Limit
        0.3
        upper Limit
        1.1
        value
        0.7
      9. group Id
        OG008
        lower Limit
        1.7
        upper Limit
        9.3
        value
        6.9
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      2
    9. group Id
      OG008
      value
      3
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with ewing sarcoma.
    id
    OG000
    title
    Cohort 1
  2. description
    Participants with non-rhabdomyosarcoma soft tissue sarcoma.
    id
    OG001
    title
    Cohort 5
  3. description
    Participants with osteosarcoma.
    id
    OG002
    title
    Cohort 6
  4. description
    Participants with rhabdomyosarcoma.
    id
    OG003
    title
    Cohort 7
  5. description
    Participants with wilms tumor.
    id
    OG004
    title
    Cohort 8
  6. description
    Participants with other tumor types with documented PD-L1 expression.
    id
    OG005
    title
    Cohort 9
  7. description
    Participants with other tumor types without documented PD-L1 expression.
    id
    OG006
    title
    Cohort 10
  8. description
    Participants with rhabdoid tumor.
    id
    OG007
    title
    Cohort 11
  9. description
    Participants with atypical teratoid rhabdoid tumor.
    id
    OG008
    title
    Cohort 12
param Type
MEDIAN
population Description
Included safety-evaluable population, defined as patients who received any amount of study drug.
reporting Status
POSTED
time Frame
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)
title
PFS as Determined by the Investigator Using Immune-Modified RECIST v1.1 for Participants With Other Solid Tumors
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice