NCT02554812 · OUTCOME

Number of Participants With Positive ADA Levels Against Utomilumab For 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: Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10

What was measured

ADA ever-positive was defined as at least one positive ADA result at any time point.

Analysis population: Analysis population was subset of safety analysis set (participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. There was no evaluable participant for PF-04518600 ADA for arms "Phase 1b SCCHN CMP-001 10 mg + Avelumab" and "Phase 1b SCCHN CMP-001 10 mg then Avelumab + PF-04518600 0.3 mg/kg." Here, "Number of participants analyzed'' signifies 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

Group	Source count
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab	0
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg	7
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg	0

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Combination F Phase 1b SCCHN: CMP-001 10 mg + Avelumab	0	Not reported	Not reported	Not reported	Not reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + Utomilumab 100 mg	5	Not reported	Not reported	Not reported	Not reported
Combination F Phase 1b SCCHN: CMP-001 10 mg Then Avelumab + PF-04518600 0.3 mg/kg	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
5
group Id
OG002
value
0

denoms

counts
group Id
OG000
value
0
group Id
OG001
value
7
group Id
OG002
value
0
units
Participants

description

ADA ever-positive was defined as at least one positive ADA result at any time point.

groups

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
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
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

Analysis population was subset of safety analysis set (participants who received at least one dose of study drug) and included participants who had at least one ADA sample collected for avelumab. There was no evaluable participant for PF-04518600 ADA for arms "Phase 1b SCCHN CMP-001 10 mg + Avelumab" and "Phase 1b SCCHN CMP-001 10 mg then Avelumab + PF-04518600 0.3 mg/kg." Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.

reporting Status

POSTED

time Frame

Pre-dose on Day 1 of Cycle 1, 2, 4, 6, and 10

title

Number of Participants With Positive ADA Levels Against Utomilumab For Combination F

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice