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NCT02541604 · OUTCOME

Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) 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
NUMBER
Unit
Percentage
Interval / dispersion
Not reported
Time frame
Baseline until disease progression, or death from any cause, whichever occurs first (up to approximately 42 months)

What was measured

Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.

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 111
Cohort 510
Cohort 610
Cohort 710
Cohort 810
Cohort 94
Cohort 104
Cohort 112

Reported measurements

Source class 1
Values in Percentage · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 10Not reportedNot reportedNot reportedNot reported
Cohort 510.0Not reportedNot reportedNot reportedNot reported
Cohort 60Not reportedNot reportedNot reportedNot reported
Cohort 70Not reportedNot reportedNot reportedNot reported
Cohort 80Not reportedNot reportedNot reportedNot reported
Cohort 90Not reportedNot reportedNot reportedNot reported
Cohort 100Not reportedNot reportedNot reportedNot reported
Cohort 110Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        10.0
      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
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
    units
    Participants
description
Note: In Cohort 5, the response was observed in a rhabdoid tumor. Participant was erroneously enrolled in the Non-rhabdomyosarcoma soft tissue sarcoma cohort.
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
NUMBER
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
Percentage of Participants With an Objective Response (Complete Response [CR] or Partial Response [PR]) as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Participants With Solid Tumors
type
PRIMARY
unit Of Measure
Percentage

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

Preserved source evidence · Not medical advice