NCT02500797 · OUTCOME

Duration of Response

Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery · Source last updated 2023-10-17

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

Measure: MEDIAN
Unit: months
Interval / dispersion: Full Range
Time frame: Time from first response to progression, assessed up to 3 years

What was measured

Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by \>= 50% of previously involved sites from nadir).

Analysis population: Participants who achieved a confirmed response are included in this analysis.

Groups in this outcome

Initial Single

Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

Initial Dual

Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

LPS Single

Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

LPS Dual

Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.

UPS/MFH Single

Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

UPS/MFH Dual

Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.

GIST Single

Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.

GIST Dual

Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.

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
Initial Single	2
Initial Dual	6
LPS Single	1
LPS Dual	2
UPS/MFH Single	1
UPS/MFH Dual	2
GIST Single	0
GIST Dual	0

Reported measurements

Source class 1

Values in months · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Initial Single	7.4	Not reported	3.2	11.6	Not reported
Initial Dual	6.2	Not reported	1.4	14.1	Not reported
LPS Single	14.5	Not reported	14.5	14.5	Not reported
LPS Dual	10.675	Not reported	8.25	13.1	Not reported
UPS/MFH Single	14.6	Not reported	14.6	14.6	Not reported
UPS/MFH Dual	3.19	Not reported	1.61	7.59	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
3.2
upper Limit
11.6
value
7.4
group Id
OG001
lower Limit
1.4
upper Limit
14.1
value
6.2
group Id
OG002
lower Limit
14.5
upper Limit
14.5
value
14.5
group Id
OG003
lower Limit
8.25
upper Limit
13.1
value
10.675
group Id
OG004
lower Limit
14.6
upper Limit
14.6
value
14.6
group Id
OG005
lower Limit
1.61
upper Limit
7.59
value
3.19

denoms

counts
group Id
OG000
value
2
group Id
OG001
value
6
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
2
group Id
OG006
value
0
group Id
OG007
value
0
units
Participants

description

dispersion Type

Full Range

groups

description
Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
OG000
title
Initial Single
description
Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
OG001
title
Initial Dual
description
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
OG002
title
LPS Single
description
Dedifferentiated liposarcoma (LPS) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
id
OG003
title
LPS Dual
description
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
OG004
title
UPS/MFH Single
description
Undifferentiated Pleomorphic Sarcoma \& Malignant Fibrous Histiocytoma (UPS/MFH) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
id
OG005
title
UPS/MFH Dual
description
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity.
id
OG006
title
GIST Single
description
Gastrointestinal stromal tumor (GIST) Cohort Patients receive 3mg/kg nivolumab IV over 30 minutes and 1mg/kg ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive 3mg/kg nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.
id
OG007
title
GIST Dual

param Type

MEDIAN

population Description

Participants who achieved a confirmed response are included in this analysis.

reporting Status

POSTED

time Frame

Time from first response to progression, assessed up to 3 years

title

Duration of Response

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice