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NCT02554812 · OUTCOME

Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination D

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 (Day 1)

What was measured

PD-L1 protein expression is determined by using TPS, which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS \>=1% and high PD-L1 expression if TPS \>= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as \>=1% and negative is defined as \<1%.

Analysis population: The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement.

Groups in this outcome

Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab

During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab

During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab

During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab

During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab

During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.

Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab

During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. 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 D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab9
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab8
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab11
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab10
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab10
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab10

Reported measurements

PD-L1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab9Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab8Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab11Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab10Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab10Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab10Not reportedNot reportedNot reportedNot reported
CD8+
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab8Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab8Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab11Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab9Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab10Not reportedNot reportedNot reportedNot reported
Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab10Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        10
      5. group Id
        OG004
        value
        10
      6. group Id
        OG005
        value
        10
    title
    PD-L1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        11
      4. group Id
        OG003
        value
        9
      5. group Id
        OG004
        value
        10
      6. group Id
        OG005
        value
        10
    title
    CD8+
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      8
    3. group Id
      OG002
      value
      11
    4. group Id
      OG003
      value
      10
    5. group Id
      OG004
      value
      10
    6. group Id
      OG005
      value
      10
    units
    Participants
description
PD-L1 protein expression is determined by using TPS, which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen is considered to have PD-L1 expression if TPS \>=1% and high PD-L1 expression if TPS \>= 50%. Tumor infiltrating CD8+ lymphocytes is defined as the number of CD8+ cells per unit area and the percent of counted cells. Positive is defined as \>=1% and negative is defined as \<1%.
groups
  1. description
    During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
    id
    OG000
    title
    Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.1 mg/kg + Avelumab
  2. description
    During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.1 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
    id
    OG001
    title
    Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.1 mg/kg + Avelumab
  3. description
    During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
    id
    OG002
    title
    Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 0.3 mg/kg + Avelumab
  4. description
    During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 0.3 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
    id
    OG003
    title
    Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 0.3 mg/kg + Avelumab
  5. description
    During Phase 1b participants received utomilumab 20 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
    id
    OG004
    title
    Combination D Phase 1b: Utomilumab 20 mg + PF-04518600 1.0 mg/kg + Avelumab
  6. description
    During Phase 1b participants received utomilumab 50 mg IV Q4W along with PF-04518600 1.0 mg/kg IV Q2W and 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks. Phase 2 was not planned.
    id
    OG005
    title
    Combination D Phase 1b: Utomilumab 50 mg + PF-04518600 1.0 mg/kg + Avelumab
param Type
COUNT_OF_PARTICIPANTS
population Description
The analysis population was a subset of the safety analysis set (all participants who received at least one dose of study drug) and included participants who had at least one biomarker parameter of PD-L1 and CD8+ lymphocytes from the corresponding assay sample with at least one baseline biomarker measurement.
reporting Status
POSTED
time Frame
Baseline (Day 1)
title
Number of Participants With Positive Programmed Death Ligand-1 (PD-L1) Biomarker Expression and Tumor Infiltrating CD8+ Lymphocytes at Baseline for Combination D
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice