NCT02554812 · OUTCOME

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

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, 3, 5, 8, 12. For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 3, 5, 8, 12

What was measured

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

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 ADA sample collected for avelumab. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure.

Groups in this outcome

Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab

During phase 1b participants with Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 1b/2 Utomilumab 100 mg + Avelumab

During Phase 1b/2 participants with NSCLC, Melanoma, SCCHN, TNBC and SCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab

During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.

Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab

During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab

During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.

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 A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab	29
Combination A Phase 1b/2 Utomilumab 100 mg + Avelumab	141
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab	29
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab	10
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab	9

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab	6	Not reported	Not reported	Not reported	Not reported
Combination A Phase 1b/2 Utomilumab 100 mg + Avelumab	51	Not reported	Not reported	Not reported	Not reported
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab	16	Not reported	Not reported	Not reported	Not reported
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab	7	Not reported	Not reported	Not reported	Not reported
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + Avelumab	6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
group Id
OG001
value
51
group Id
OG002
value
16
group Id
OG003
value
7
group Id
OG004
value
6

denoms

counts
group Id
OG000
value
29
group Id
OG001
value
141
group Id
OG002
value
29
group Id
OG003
value
10
group Id
OG004
value
9
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 Non-Small Cell Lung Cancer (NSCLC) received utomilumab 500 mg intravenously (IV) every 4 weeks (Q4W) with 10 milligrams per kilogram (mg/kg) of avelumab administered IV every 2 weeks (Q2W) for 2 cycles, where each cycle was of 4 weeks.
id
OG000
title
Combination A Phase 1b NSCLC: Utomilumab 500 mg + Avelumab
description
During Phase 1b/2 participants with NSCLC, Melanoma, SCCHN, TNBC and SCLC received utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
OG001
title
Combination A Phase 1b/2 Utomilumab 100 mg + Avelumab
description
During phase 1b participants with NSCLC received utomilumab 20 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W for 2 cycles, where each cycle was of 4 weeks.
id
OG002
title
Combination A Phase 1b NSCLC: Utomilumab 20 mg + Avelumab
description
During Phase 2 participants with NSCLC received utomilumab 100 mg IV Q4W for cycle 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
id
OG003
title
Combination A Phase 2 1L NSCLC: Utomilumab Then Utomilumab + Avelumab
description
During Phase 2 participants with NSCLC received avelumab 10 mg/kg administered IV Q2W for cycles 1 then utomilumab 100 mg IV Q4W with 10 mg/kg of avelumab administered IV Q2W starting at cycle 2.
id
OG004
title
Combination A Phase 2 1L NSCLC: Avelumab Then Utomilumab + 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 ADA sample collected for avelumab. 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, 3, 5, 8, 12. For ''Phase 2 1L NSCLC: Avelumab then Utomilumab + Avelumab'' reporting group: Day 1 of Cycle 3, 5, 8, 12

title

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

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice