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NCT02554812 · OUTCOME

Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F

A Study Of Avelumab In Combination With Other Cancer Immunotherapies In Advanced Malignancies (JAVELIN Medley) · Source last updated 2024-07-30

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
Baseline up to end of treatment/withdrawal (maximum of 3 years)

What was measured

The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening chemistry laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.

Analysis population: All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.

Groups in this outcome

Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab

During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.

Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg

During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.

Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg

During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.

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

Analysis denominator · Participants

GroupSource count
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab5
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg7
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg7

Reported measurements

Participants with any grade >= 3 Alanine Aminotransferase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg0Not reportedNot reportedNot reportedNot reported
Participants with any grade >= 3 Alkaline Phosphatase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg0Not reportedNot reportedNot reportedNot reported
Participants with any grade >= 3 Aspartate Aminotransferase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg1Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg0Not reportedNot reportedNot reportedNot reported
Participants with any grade >= 3 Blood Bilirubin Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg0Not reportedNot reportedNot reportedNot reported
Participants with any grade >= 3 Creatinine Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg0Not reportedNot reportedNot reportedNot reported
Participants with any grade >= 3 Hyperglycemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg1Not reportedNot reportedNot reportedNot reported
Participants with any grade >= 3 Lipase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab1Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg1Not reportedNot reportedNot reportedNot reported
Participants with any grade >= 3 Serum Amylase Increased
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab1Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg0Not reportedNot reportedNot reportedNot reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Participants with any grade >= 3 Alanine Aminotransferase Increased
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Participants with any grade >= 3 Alkaline Phosphatase Increased
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Participants with any grade >= 3 Aspartate Aminotransferase Increased
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Participants with any grade >= 3 Blood Bilirubin Increased
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Participants with any grade >= 3 Creatinine Increased
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Participants with any grade >= 3 Hyperglycemia
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Participants with any grade >= 3 Lipase Increased
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Participants with any grade >= 3 Serum Amylase Increased
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      7
    units
    Participants
description
The laboratory results were graded according to the NCI CTCAE v4.03 severity grade. Grade 1=mild AE. Grade 2=moderate AE. Grade 3=severe AE. Grade 4=life-threatening consequences; urgent intervention indicated. Number of participants with new abnormal or worsening chemistry laboratory test is presented." Participants with any grade \>=3 is presented for following parameters: Alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatinine increased, hyperglycemia, lipase increased and serum amylase increased. Baseline is defined as the last assessment prior to the date/time of the first dose of study treatment.
groups
  1. description
    During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 sub-cutaneous \[SC\] administered at weekly intervals, followed by 5 intra tumoral \[IT\] administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W. Phase 2 was not planned.
    id
    OG000
    title
    Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab
  2. description
    During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus utomilumab 100 mg administered IV Q4W. Phase 2 was not planned.
    id
    OG001
    title
    Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg
  3. description
    During Phase 1b participants with SCCHN received CMP-001 at 10 mg for an initial 7 doses (2 SC administered at weekly intervals, followed by 5 IT administered at weekly intervals) and then administered IT Q2W for all cohorts along with 10 mg/kg of avelumab administered IV Q2W all cohorts plus PF-04518600 at 0.3 mg/kg administered IV Q2W. Phase 2 was not planned.
    id
    OG002
    title
    Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received at least one dose of study drug and who could be evaluated for CTCAE criteria for each parameter in each treatment group. Participants were classified according to study treatment actually received. If participant received more than one study treatment, participant was classified according to first treatment received. Here, "N''=number of participants evaluable for this outcome measure.
reporting Status
POSTED
time Frame
Baseline up to end of treatment/withdrawal (maximum of 3 years)
title
Number of Participants With New Abnormal or Worsening Chemistry Laboratory Test Results During the On-Treatment Period by Maximum CTCAE Grade >=3: Combination F
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice