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NCT02541604 · OUTCOME

Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With 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.

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 10
Cohort 51
Cohort 60
Cohort 70
Cohort 80
Cohort 90
Cohort 100
Cohort 110

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 513.2Not reportedNANAThere was only 1 participant.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        There was only 1 participant.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        13.2
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      0
    6. group Id
      OG005
      value
      0
    7. group Id
      OG006
      value
      0
    8. group Id
      OG007
      value
      0
    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
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
Duration of Response (DOR) as Determined by the Investigator Using RECIST v1.1 Criteria in Participants With Solid Tumors
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice