NCT01451632 · OUTCOME

Immunogenicity

A Safety Study of MM-121 With Cetuximab and Irinotecan in Patients With Advanced Cancers · Source last updated 2016-09-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: Not reported
Interval / dispersion: Not reported
Time frame: Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction

What was measured

Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).

Groups in this outcome

Part 1: Cohort 1

MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses

Part 1: Cohort 2a

MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW

Part 1: Cohort 2b

MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW

Part 1: Cohort 3a

MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW

Part 1: Cohort 3b

MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW

Part 1: Cohort 4

MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW

Part 1: Expansion Cohort

MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW

Part 2: Cohort 1

MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W

Part 2: Cohort 2

MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W

Part 2: Expansion Cohort

MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 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
Part 1: Cohort 1	8
Part 1: Cohort 2a	4
Part 1: Cohort 2b	3
Part 1: Cohort 3a	3
Part 1: Cohort 3b	4
Part 1: Cohort 4	4
Part 1: Expansion Cohort	8
Part 2: Cohort 1	6
Part 2: Cohort 2	4
Part 2: Expansion Cohort	4

Reported measurements

Source class 1

Values in Not reported · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Part 1: Cohort 1	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
Part 1: Cohort 2a	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
Part 1: Cohort 2b	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
Part 1: Cohort 3a	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
Part 1: Cohort 3b	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
Part 1: Cohort 4	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
Part 1: Expansion Cohort	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
Part 2: Cohort 1	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
Part 2: Cohort 2	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
Part 2: Expansion Cohort	NA	Not reported	Not reported	Not reported	The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value

Complete source fields

classes

categories
measurements
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG000
value
NA
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG001
value
NA
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG002
value
NA
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG003
value
NA
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG004
value
NA
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG005
value
NA
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG006
value
NA
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG007
value
NA
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG008
value
NA
comment
The very small number of patients in each cohort and the very low levels of positivity resulted in a non-reportable value
group Id
OG009
value
NA

denoms

counts
group Id
OG000
value
8
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
4
group Id
OG005
value
4
group Id
OG006
value
8
group Id
OG007
value
6
group Id
OG008
value
4
group Id
OG009
value
4
units
Participants

description

Samples were collected to determine the presence of an immunologic reaction to MM-121 (i.e. human anti-human antibodies).

groups

description
MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
id
OG000
title
Part 1: Cohort 1
description
MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
id
OG001
title
Part 1: Cohort 2a
description
MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
id
OG002
title
Part 1: Cohort 2b
description
MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
id
OG003
title
Part 1: Cohort 3a
description
MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
id
OG004
title
Part 1: Cohort 3b
description
MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
id
OG005
title
Part 1: Cohort 4
description
MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
id
OG006
title
Part 1: Expansion Cohort
description
MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
id
OG007
title
Part 2: Cohort 1
description
MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
id
OG008
title
Part 2: Cohort 2
description
MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
id
OG009
title
Part 2: Expansion Cohort

param Type

NUMBER

reporting Status

POSTED

time Frame

Samples were collected for all patients pre-dose on all cycles for duration of treatment, the longest of which was 48.1 weeks, and a collection was made post-infusion in any case of infusion reaction

title

Immunogenicity

type

SECONDARY

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Preserved source evidence · Not medical advice