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NCT01772004 · OUTCOME

Dose Expansion Cohort: Number of Participants With Atleast 1 Positive Anti Drug Antibodies (ADA) Assay

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
Dose Expansion: Baseline up to Day 2023

What was measured

Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.

Analysis population: Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.

Groups in this outcome

Primary Expansion Cohort: NSCLC, Post-platinum Doublet

Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Primary Expansion Cohort: NSCLC, First Line

Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Primary Expansion Cohort: Metastatic Breast Cancer

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

Primary Expansion Cohort: GC/GEJC Progressed

Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Primary Expansion Cohort: GC/GEJC Non Progressed

Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Secondary Expansion Cohort: Colorectal Cancer

Participants with colorectal cancer 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.

Secondary Expansion Cohort: Castrate-resistant Prostate Cancer

Participants with castrate-resistant prostate cancer 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.

Secondary Expansion Cohort: Adrenocortical Carcinoma

Participants with adrenocortical 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.

Secondary Expansion Cohort: Melanoma

Participants with melanoma 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.

Secondary Expansion Cohort: Mesothelioma

Participants with mesothelioma 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.

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.

Secondary Expansion Cohort: Ovarian Cancer

Participants with ovarian 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.

Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)

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

Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)

Participants with Renal cell carcinoma who failed 1 prior systemic first-line regimen received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a second line treatment in secondary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: Ovarian Cancer

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

Efficacy 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 efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: GC/GEJC, Third Line

Participants with gastric (GC) and gastroesophageal junction cancer (GEJC) who have failed both a first-line chemotherapy regimen and subsequent ramucirumab therapy, received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks as a third-line treatment in efficacy expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.

Efficacy Expansion Cohort: HNSCC

Participants with head and neck squamous cell carcinoma (HNSCC) received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in efficacy 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
Primary Expansion Cohort: NSCLC, Post-platinum Doublet184
Primary Expansion Cohort: NSCLC, First Line155
Primary Expansion Cohort: Metastatic Breast Cancer168
Primary Expansion Cohort: GC/GEJC Progressed60
Primary Expansion Cohort: GC/GEJC Non Progressed90
Secondary Expansion Cohort: Colorectal Cancer21
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer18
Secondary Expansion Cohort: Adrenocortical Carcinoma50
Secondary Expansion Cohort: Melanoma51
Secondary Expansion Cohort: Mesothelioma53
Secondary Expansion Cohort: Urothelial Carcinoma43
Secondary Expansion Cohort: Ovarian Cancer125
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)61
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)20
Efficacy Expansion Cohort: Ovarian Cancer103
Efficacy Expansion Cohort: Urothelial Carcinoma201
Efficacy Expansion Cohort: GC/GEJC, Third Line130
Efficacy Expansion Cohort: HNSCC151

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Primary Expansion Cohort: NSCLC, Post-platinum Doublet17Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: NSCLC, First Line9Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: Metastatic Breast Cancer17Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Progressed3Not reportedNot reportedNot reportedNot reported
Primary Expansion Cohort: GC/GEJC Non Progressed6Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Colorectal Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Castrate-resistant Prostate Cancer0Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Adrenocortical Carcinoma4Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Melanoma5Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Mesothelioma3Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Urothelial Carcinoma2Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Ovarian Cancer5Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (First Line)5Not reportedNot reportedNot reportedNot reported
Secondary Expansion Cohort: Renal Cell Carcinoma (Second Line)3Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Ovarian Cancer5Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: Urothelial Carcinoma17Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: GC/GEJC, Third Line6Not reportedNot reportedNot reportedNot reported
Efficacy Expansion Cohort: HNSCC5Not reportedNot reportedNot reportedNot reported
Complete source fields
calculate Pct
false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        17
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        6
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        4
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        3
      11. group Id
        OG010
        value
        2
      12. group Id
        OG011
        value
        5
denoms
  1. counts
    1. group Id
      OG000
      value
      184
    2. group Id
      OG001
      value
      155
    3. group Id
      OG002
      value
      168
    4. group Id
      OG003
      value
      60
    5. group Id
      OG004
      value
      90
    6. group Id
      OG005
      value
      21
    7. group Id
      OG006
      value
      18
    8. group Id
      OG007
      value
      50
    9. group Id
      OG008
      value
      51
    10. group Id
      OG009
      value
      53
    11. group Id
      OG010
      value
      43
    12. group Id
      OG011
      value
      125
    units
    Participants
description
Serum samples were analyzed by a validated electrochemiluminescence immunoassay to detect the presence of antidrug antibodies (ADA). Number of participants with ADA positive results for Avelumab were reported.
groups
  1. description
    Participants with non-small cell lung cancer (NSCLC), who had progressed after 1 line of platinum-containing doublet chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG000
    title
    Primary Expansion Cohort: NSCLC, Post-platinum Doublet
  2. description
    Participants with non-small cell lung cancer (NSCLC), first line received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG001
    title
    Primary Expansion Cohort: NSCLC, First Line
  3. description
    Participants with metastatic breast cancer received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG002
    title
    Primary Expansion Cohort: Metastatic Breast Cancer
  4. description
    Participants with gastric and gastroesophageal cancer who progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG003
    title
    Primary Expansion Cohort: GC/GEJC Progressed
  5. description
    Participants with gastric and gastroesophageal cancer who non-progressed on or after first-line chemotherapy received intravenous infusion of Avelumab at a dose of 10.0 mg/kg once every 2 weeks in primary expansion cohort until confirmed progression, unacceptable toxicity, or any reason for withdrawal from the trial or IMP occurs.
    id
    OG004
    title
    Primary Expansion Cohort: GC/GEJC Non Progressed
  6. description
    Participants with colorectal cancer 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
    OG005
    title
    Secondary Expansion Cohort: Colorectal Cancer
  7. description
    Participants with castrate-resistant prostate cancer 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
    OG006
    title
    Secondary Expansion Cohort: Castrate-resistant Prostate Cancer
  8. description
    Participants with adrenocortical 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
    OG007
    title
    Secondary Expansion Cohort: Adrenocortical Carcinoma
  9. description
    Participants with melanoma 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
    OG008
    title
    Secondary Expansion Cohort: Melanoma
  10. description
    Participants with mesothelioma 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
    OG009
    title
    Secondary Expansion Cohort: Mesothelioma
  11. 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
    OG010
    title
    Secondary Expansion Cohort: Urothelial Carcinoma
  12. description
    Participants with ovarian 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
    OG011
    title
    Secondary Expansion Cohort: Ovarian Cancer
param Type
COUNT_OF_PARTICIPANTS
population Description
Safety analysis set included all participants who have received at least 1 dose of study treatment. Here "Overall number of participants analyzed" signifies those who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Dose Expansion: Baseline up to Day 2023
title
Dose Expansion Cohort: Number of Participants With Atleast 1 Positive Anti Drug Antibodies (ADA) Assay
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice