Skip to content

TriangleGet started

← Full study record

NCT02554812 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in 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: GEOMETRIC_MEAN
Unit: Nanogram per milliliter
Interval / dispersion: Geometric Coefficient of Variation
Time frame: 1-hour post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10

What was measured

Cmax is maximum observed plasma concentration.

Analysis population: Pharmacokinetic (PK) analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.

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	13
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	23

Reported measurements

Avelumab Cycle 1/Day1-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	9
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	12
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	7
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	11
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	22

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	220.6	26	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	257.6	65	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	213.7	30	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	219.8	22	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	178.4	31	Not reported	Not reported	Not reported

Avelumab Cycle 1/Day8-168 Hour

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	11
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	11
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	8
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	13
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	23

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	54.00	51	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	42.66	50	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	49.85	45	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	50.86	35	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	47.68	33	Not reported	Not reported	Not reported

Avelumab Cycle 1/Day15-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	7
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	10
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	6
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	9
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	20

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	241.9	23	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	240.3	17	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	228.7	33	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	235.5	29	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	180.3	68	Not reported	Not reported	Not reported

Avelumab Cycle 2/Day1-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	8
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	8
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	6
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	10
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	20

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	242.8	22	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	256.2	18	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	277.1	27	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	249.1	22	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	188.4	22	Not reported	Not reported	Not reported

Avelumab Cycle 4/Day1-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	3
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	2
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	2
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	6
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	11

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	223.9	19	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	204.1	44	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	254.4	10	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	184.9	31	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	205.6	21	Not reported	Not reported	Not reported

Avelumab Cycle 6/Day1-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	0
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	1
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	0
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	3
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	5

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	143.0	NA	Not reported	Not reported	Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	280.6	18	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	137.0	110	Not reported	Not reported	Not reported

Avelumab Cycle 10/Day1-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	0
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	0
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	0
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	1
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	4

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	231.0	NA	Not reported	Not reported	Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	197.2	13	Not reported	Not reported	Not reported

PF- 04518600 Cycle 1/Day1-1 Hour/EOI

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	7
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	12
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	23

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	6413	21	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	21560	25	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	74090	13	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	6919	28	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	6085	37	Not reported	Not reported	Not reported

PF-04518600 Cycle 1/Day8-168 Hour

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	11
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	11
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	8
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	13
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	23

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	2669	51	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	9427	25	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	31650	34	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	3131	32	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	2631	28	Not reported	Not reported	Not reported

PF-04518600 Cycle 1/Day15-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	9
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	10
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	7
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	13
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	19

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	5969	77	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	27460	24	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	96640	22	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	6697	71	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	7173	35	Not reported	Not reported	Not reported

PF-04518600 Cycle 2/Day1-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	11
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	8
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	7
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	12
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	23

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	7776	33	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	31880	16	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	104100	56	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	9212	30	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	7627	25	Not reported	Not reported	Not reported

PF-04518600 Cycle 4/Day1-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	3
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	0
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	3
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	9
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	12

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	8792	43	Not reported	Not reported	Not reported
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	155000	20	Not reported	Not reported	Not reported
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	11730	61	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	10180	36	Not reported	Not reported	Not reported

PF-04518600 Cycle 6/Day1-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	0
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	1
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	0
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	6
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	5

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	32000	NA	Not reported	Not reported	Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	14020	27	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	9753	10	Not reported	Not reported	Not reported

PF-04518600 Cycle 10/Day1-1 Hour/EOI

Analysis denominator · Participants

Group	Source count
Combination B Phase 1b: PF-04518600 0.3 mg/kg + Avelumab	0
Combination B Phase 1b: PF-04518600 1.0 mg/kg + Avelumab	0
Combination B Phase 1b: PF-04518600 3.0 mg/kg + Avelumab	0
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	2
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	4

Values in Nanogram per milliliter · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
Combination B Phase 2 NSCLC: PF-04518600 0.3 mg/kg + Avelumab	14060	16	Not reported	Not reported	Not reported
Combination B Phase 2 SCCHN: PF-04518600 0.3 mg/kg + Avelumab	10660	18	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
26
value
220.6
group Id
OG001
spread
65
value
257.6
group Id
OG002
spread
30
value
213.7
group Id
OG003
spread
22
value
219.8
group Id
OG004
spread
31
value
178.4
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
12
group Id
OG002
value
7
group Id
OG003
value
11
group Id
OG004
value
22
units
Participants
title
Avelumab Cycle 1/Day1-1 Hour/EOI
categories
measurements
group Id
OG000
spread
51
value
54.00
group Id
OG001
spread
50
value
42.66
group Id
OG002
spread
45
value
49.85
group Id
OG003
spread
35
value
50.86
group Id
OG004
spread
33
value
47.68
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
11
group Id
OG002
value
8
group Id
OG003
value
13
group Id
OG004
value
23
units
Participants
title
Avelumab Cycle 1/Day8-168 Hour
categories
measurements
group Id
OG000
spread
23
value
241.9
group Id
OG001
spread
17
value
240.3
group Id
OG002
spread
33
value
228.7
group Id
OG003
spread
29
value
235.5
group Id
OG004
spread
68
value
180.3
denoms
counts
group Id
OG000
value
7
group Id
OG001
value
10
group Id
OG002
value
6
group Id
OG003
value
9
group Id
OG004
value
20
units
Participants
title
Avelumab Cycle 1/Day15-1 Hour/EOI
categories
measurements
group Id
OG000
spread
22
value
242.8
group Id
OG001
spread
18
value
256.2
group Id
OG002
spread
27
value
277.1
group Id
OG003
spread
22
value
249.1
group Id
OG004
spread
22
value
188.4
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
8
group Id
OG002
value
6
group Id
OG003
value
10
group Id
OG004
value
20
units
Participants
title
Avelumab Cycle 2/Day1-1 Hour/EOI
categories
measurements
group Id
OG000
spread
19
value
223.9
group Id
OG001
spread
44
value
204.1
group Id
OG002
spread
10
value
254.4
group Id
OG003
spread
31
value
184.9
group Id
OG004
spread
21
value
205.6
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
6
group Id
OG004
value
11
units
Participants
title
Avelumab Cycle 4/Day1-1 Hour/EOI
categories
measurements
comment
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
group Id
OG001
spread
NA
value
143.0
group Id
OG003
spread
18
value
280.6
group Id
OG004
spread
110
value
137.0
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
0
group Id
OG003
value
3
group Id
OG004
value
5
units
Participants
title
Avelumab Cycle 6/Day1-1 Hour/EOI
categories
measurements
comment
Geometric Coefficient of Variation was not estimable as there was only 1 participant analyzed.
group Id
OG003
spread
NA
value
231.0
group Id
OG004
spread
13
value
197.2
denoms
counts
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
0
group Id
OG003
value
1
group Id
OG004
value
4
units
Participants
title
Avelumab Cycle 10/Day1-1 Hour/EOI
categories
measurements
group Id
OG000
spread
21
value
6413
group Id
OG001
spread
25
value
21560
group Id
OG002
spread
13
value
74090
group Id
OG003
spread
28
value
6919
group Id
OG004
spread
37
value
6085
denoms
counts
group Id
OG000
value
12
group Id
OG001
value
12
group Id
OG002
value
7
group Id
OG003
value
12
group Id
OG004
value
23
units
Participants
title
PF- 04518600 Cycle 1/Day1-1 Hour/EOI
categories
measurements
group Id
OG000
spread
51
value
2669
group Id
OG001
spread
25
value
9427
group Id
OG002
spread
34
value
31650
group Id
OG003
spread
32
value
3131
group Id
OG004
spread
28
value
2631
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
11
group Id
OG002
value
8
group Id
OG003
value
13
group Id
OG004
value
23
units
Participants
title
PF-04518600 Cycle 1/Day8-168 Hour
categories
measurements
group Id
OG000
spread
77
value
5969
group Id
OG001
spread
24
value
27460
group Id
OG002
spread
22
value
96640
group Id
OG003
spread
71
value
6697
group Id
OG004
spread
35
value
7173
denoms
counts
group Id
OG000
value
9
group Id
OG001
value
10
group Id
OG002
value
7
group Id
OG003
value
13
group Id
OG004
value
19
units
Participants
title
PF-04518600 Cycle 1/Day15-1 Hour/EOI
categories
measurements
group Id
OG000
spread
33
value
7776
group Id
OG001
spread
16
value
31880
group Id
OG002
spread
56
value
104100
group Id
OG003
spread
30
value
9212
group Id
OG004
spread
25
value
7627
denoms
counts
group Id
OG000
value
11
group Id
OG001
value
8
group Id
OG002
value
7
group Id
OG003
value
12
group Id
OG004
value
23
units
Participants
title
PF-04518600 Cycle 2/Day1-1 Hour/EOI
categories
measurements
group Id
OG000
spread
43
value
8792
group Id
OG002
spread
20
value
155000
group Id
OG003
spread
61
value
11730
group Id
OG004
spread
36
value
10180
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
0
group Id
OG002
value
3
group Id
OG003
value
9
group Id
OG004
value
12
units
Participants
title
PF-04518600 Cycle 4/Day1-1 Hour/EOI

denoms

counts
group Id
OG000
value
12
group Id
OG001
value
12
group Id
OG002
value
8
group Id
OG003
value
13
group Id
OG004
value
23
units
Participants

description

Cmax is maximum observed plasma concentration.

dispersion Type

Geometric Coefficient of Variation

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

GEOMETRIC_MEAN

population Description

Pharmacokinetic (PK) analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK concentrations of interest for Avelumab, Utomilumab, PD 0360324, PF-04518600. Here, "Number of participants analyzed'' signifies number of participants evaluable for this outcome measure, where "Number Analyzed" signifies number of participants evaluable for specified time points.

reporting Status

POSTED

time Frame

1-hour post-dose on Day 1,15 of Cycle 1; Day 8 of Cycle 1 (non-dosing); Day 1 of Cycle 2, 4, 6 and Cycle 10

title

Maximum Observed Plasma Concentration (Cmax) of Avelumab and PF-04518600 in Combination B

type

SECONDARY

unit Of Measure

Nanogram per milliliter

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

Preserved source evidence · Not medical advice