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NCT01772004 · OUTCOME

Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee

Avelumab in Metastatic or Locally Advanced Solid Tumors (JAVELIN Solid Tumor) · Source last updated 2021-12-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Secondary Urothelial Carcinoma Dose Expansion: Baseline up to Day 931

What was measured

Confirmed Best Overall Response (BOR) was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1and as adjudicated by an Independent Endpoint Review Committee (IERC) is defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with BOR in each category (CR, PR, SD, PD) were reported.

Analysis population: FAS included all participants who have received at least 1 dose of study treatment. This outcome measure was planned to be analyzed in Secondary Urothelial Carcinoma Cohort only.

Groups in this outcome

Secondary Expansion Cohort: Urothelial Carcinoma

Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

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

Analysis denominator · Participants

GroupSource count
Secondary Expansion Cohort: Urothelial Carcinoma44

Reported measurements

Complete Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Secondary Expansion Cohort: Urothelial Carcinoma6Not reportedNot reportedNot reportedNot reported
Partial Response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Secondary Expansion Cohort: Urothelial Carcinoma1Not reportedNot reportedNot reportedNot reported
Stable Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Secondary Expansion Cohort: Urothelial Carcinoma16Not reportedNot reportedNot reportedNot reported
Non-CR/Non-PD
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Secondary Expansion Cohort: Urothelial Carcinoma0Not reportedNot reportedNot reportedNot reported
Progressive Disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Secondary Expansion Cohort: Urothelial Carcinoma16Not reportedNot reportedNot reportedNot reported
Not Evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Secondary Expansion Cohort: Urothelial Carcinoma5Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Complete Response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Partial Response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Stable Disease
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Non-CR/Non-PD
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Progressive Disease
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Not Evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    units
    Participants
description
Confirmed Best Overall Response (BOR) was determined according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1and as adjudicated by an Independent Endpoint Review Committee (IERC) is defined as best response of any of complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) recorded from date of randomization until disease progression/recurrence (taking smallest measurement recorded since start of treatment as reference). CR: Disappearance of all evidence of target/non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. SD: Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. PD: at least a 20% increase in SLD, taking as reference smallest SLD recorded from baseline/appearance of 1or more new lesions and unequivocal progression of non-target lesions. Number of participants with BOR in each category (CR, PR, SD, PD) were reported.
groups
  1. description
    Participants with urothelial carcinoma received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG000
    title
    Secondary Expansion Cohort: Urothelial Carcinoma
param Type
COUNT_OF_PARTICIPANTS
population Description
FAS included all participants who have received at least 1 dose of study treatment. This outcome measure was planned to be analyzed in Secondary Urothelial Carcinoma Cohort only.
reporting Status
POSTED
time Frame
Secondary Urothelial Carcinoma Dose Expansion: Baseline up to Day 931
title
Dose Expansion Cohort (Secondary Urothelial Carcinoma Cohort): Number of Participants With Confirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Adjudicated by an Independent Endpoint Review Committee
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice