NCT02554812 · OUTCOME

OS for Combination B

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: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)

What was measured

OS was defined as the time (in months) from the date of first dose of study drug to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at the date of last contact. OS was analyzed by Kaplan-Meier method.

Analysis population: Full analysis set included all enrolled participants who received at least one dose of study drug.

Groups in this outcome

Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab

During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab

During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab

During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.

Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab

During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab

During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.

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 B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	12
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	12
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	8
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	14
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	25

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	8.5	Not reported	1.6	NA	Upper limit of 95% CI was not estimable as there were less number of participants with an event.
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	13.5	Not reported	4.0	NA	Upper limit of 95% CI was not estimable as there were less number of participants with an event.
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	7.1	Not reported	2.4	20.8	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	15.9	Not reported	6.3	NA	Upper limit of 95% CI was not estimable as there were less number of participants with an event.
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	10.7	Not reported	6.7	14.5	Not reported

Complete source fields

classes

categories
measurements
comment
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
group Id
OG000
lower Limit
1.6
upper Limit
NA
value
8.5
comment
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
group Id
OG001
lower Limit
4.0
upper Limit
NA
value
13.5
group Id
OG002
lower Limit
2.4
upper Limit
20.8
value
7.1
comment
Upper limit of 95% CI was not estimable as there were less number of participants with an event.
group Id
OG003
lower Limit
6.3
upper Limit
NA
value
15.9
group Id
OG004
lower Limit
6.7
upper Limit
14.5
value
10.7

denoms

counts
group Id
OG000
value
12
group Id
OG001
value
12
group Id
OG002
value
8
group Id
OG003
value
14
group Id
OG004
value
25
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
During Phase 1b participants received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
id
OG000
title
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab
description
During Phase 1b participants received PF-04518600 1.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
id
OG001
title
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab
description
During Phase 1b participants received PF-04518600 3.0 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W. Phase 2 in the melanoma cohort was not planned.
id
OG002
title
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab
description
During Phase 2 participants with NSCLC received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
id
OG003
title
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab
description
During Phase 2 participants with SCCHN received PF-04518600 0.3 mg/kg IV Q2W with 10 mg/kg of avelumab administered IV Q2W.
id
OG004
title
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab

param Type

MEDIAN

population Description

Full analysis set included all enrolled participants who received at least one dose of study drug.

reporting Status

POSTED

time Frame

From first dose of study drug to date of death from any cause or data censoring date, whichever occurred first (maximum up to 7.3 years)

title

OS for Combination B

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice