NCT02573259 · OUTCOME

Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2

A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors · Source last updated 2021-12-13

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 up to end of treatment (maximum of 851 days)

What was measured

Number of participants with NAb positive against PF-06801591 after IV and SC dosing - Part 1 and Part 2. A participant was NAb positive if (1) baseline titer was missing or negative and participant had ≥ 1 post-treatment positive titer (treatment-induced), or (2) positive titer at baseline and had a ≥ 0.602 in titer from baseline in ≥ 1 post-treatment sample (treatment-boosted). Participants who were NAb positive at baseline but did not become boosted post-treatment were considered as NAb negative.

Analysis population: Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result. NAb-negative participants included participants who were ADA negative or ADA-positive participants who tested negative in the NAb assay.

Groups in this outcome

Part 1: PF-06801591 300 mg (Subcutaneously [SC])

Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)

Part 2: PF-06801591 300 mg (SC) for NSCLC

Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)

Part 2: PF-06801591 300 mg (SC) for UC

Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)

Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])

Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)

Part 1: PF-06801591 1 mg/kg (IV)

Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)

Part 1: PF-06801591 3 mg/kg (IV)

Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)

Part 1: PF-06801591 10 mg/kg (IV)

Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)

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
Part 1: PF-06801591 300 mg (Subcutaneously [SC])	14
Part 2: PF-06801591 300 mg (SC) for NSCLC	64
Part 2: PF-06801591 300 mg (SC) for UC	37
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])	2
Part 1: PF-06801591 1 mg/kg (IV)	6
Part 1: PF-06801591 3 mg/kg (IV)	7
Part 1: PF-06801591 10 mg/kg (IV)	6

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: PF-06801591 300 mg (Subcutaneously [SC])	0	Not reported	Not reported	Not reported	Not reported
Part 2: PF-06801591 300 mg (SC) for NSCLC	3	Not reported	Not reported	Not reported	Not reported
Part 2: PF-06801591 300 mg (SC) for UC	1	Not reported	Not reported	Not reported	Not reported
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])	0	Not reported	Not reported	Not reported	Not reported
Part 1: PF-06801591 1 mg/kg (IV)	0	Not reported	Not reported	Not reported	Not reported
Part 1: PF-06801591 3 mg/kg (IV)	0	Not reported	Not reported	Not reported	Not reported
Part 1: PF-06801591 10 mg/kg (IV)	0	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
0
group Id
OG006
value
0

denoms

counts
group Id
OG000
value
14
group Id
OG001
value
64
group Id
OG002
value
37
group Id
OG003
value
2
group Id
OG004
value
6
group Id
OG005
value
7
group Id
OG006
value
6
units
Participants

description

groups

description
Participants received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 419 days)
id
OG000
title
Part 1: PF-06801591 300 mg (Subcutaneously [SC])
description
Participants with NSCLC received PF-06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 851 days)
id
OG001
title
Part 2: PF-06801591 300 mg (SC) for NSCLC
description
Participants with UC received PF- 06801591 300 mg SC every 4 weeks for 28-day cycles. (maximum of 841 days)
id
OG002
title
Part 2: PF-06801591 300 mg (SC) for UC
description
Participants received PF-06801591 0.5 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1186 days)
id
OG003
title
Part 1: PF-06801591 0.5 mg/kg (Intravenously [IV])
description
Participants received PF-06801591 1 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 659 days)
id
OG004
title
Part 1: PF-06801591 1 mg/kg (IV)
description
Participants received PF-06801591 3 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 1606 days)
id
OG005
title
Part 1: PF-06801591 3 mg/kg (IV)
description
Participants received PF-06801591 10 mg/kg IV every 3 weeks for 21-day cycles. (maximum of 445 days)
id
OG006
title
Part 1: PF-06801591 10 mg/kg (IV)

param Type

COUNT_OF_PARTICIPANTS

population Description

Analysis population included all participants who received at least 1 dose of study treatment and had at least 1 post-treatment ADA result. NAb-negative participants included participants who were ADA negative or ADA-positive participants who tested negative in the NAb assay.

reporting Status

POSTED

time Frame

Baseline up to end of treatment (maximum of 851 days)

title

Number of Participants With Neutralizing Antibodies (NAb) Positive Against PF-06801591 - Part 1 and Part 2

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice