NCT02301039 · OUTCOME

Objective Response Rate

SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas · Source last updated 2020-09-29

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: Assessments will be conducted at 8 weeks, up to 5 years

What was measured

The Objective Response Rate (ORR) is the percentage of patient's tumor that shrinks or disappears after treatment. ORR will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, whereby Complete Response is defined as the disappearance of all target lesions and Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions in reference to the baseline diameters. Overall Response (OR) = CR + PR.

Analysis population: There were 40 of 42 patients in the soft tissue sarcoma cohort who were evaluable for response. There were 40 of 42 patients in the bone sarcoma cohort who were evaluable for response. There were 53 of 60 patients in the expansion cohort who were evaluable for response.

Groups in this outcome

Soft Tissue Sarcoma

Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab

Bone Sarcoma

Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab

Expansion Cohort

Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks

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
Soft Tissue Sarcoma	40
Bone Sarcoma	40
Expansion Cohort	53

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Soft Tissue Sarcoma	7	Not reported	Not reported	Not reported	Not reported
Bone Sarcoma	2	Not reported	Not reported	Not reported	Not reported
Expansion Cohort	7	Not reported	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
7.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
32.8
estimate Comment
Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients
group Description
An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
group Ids
OG000
non Inferiority Comment
An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
non Inferiority Type
SUPERIORITY
param Type
Binomial estimate of response rate of PR
param Value
17.5
ci Lower Limit
1.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
16.9
estimate Comment
Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients
group Description
An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
group Ids
OG001
non Inferiority Type
SUPERIORITY
param Type
Binomial estimate of response rate of PR
param Value
5.0
ci Lower Limit
5.5
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
25.3
estimate Comment
Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients
group Description
An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
group Ids
OG002
non Inferiority Type
SUPERIORITY
param Type
Binomial estimate of response rate of PR
param Value
13.0

Complete source fields

analyses

ci Lower Limit
7.3
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
32.8
estimate Comment
Clopper-Pearson (Exact) Confidence Interval. Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients
group Description
An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
group Ids
OG000
non Inferiority Comment
An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
non Inferiority Type
SUPERIORITY
param Type
Binomial estimate of response rate of PR
param Value
17.5
ci Lower Limit
1.0
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
16.9
estimate Comment
Clopper-Pearson exact confidence interval; Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients
group Description
An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
group Ids
OG001
non Inferiority Type
SUPERIORITY
param Type
Binomial estimate of response rate of PR
param Value
5.0
ci Lower Limit
5.5
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
25.3
estimate Comment
Clopper-Pearson (Exact) Confidence Interval Excluded from rate due to no response evaluation: Soft Tissue: 2; Bone: 2; Expansion: 7 patients
group Description
An objective response rate of 25% will be considered clinically meaningful and a response rate less than 10% will be considered lack of efficacy. The treatment will be considered a success if 8 or more of 40 enrolled patients have a PR or better by RECIST 1.1.
group Ids
OG002
non Inferiority Type
SUPERIORITY
param Type
Binomial estimate of response rate of PR
param Value
13.0

classes

categories
measurements
group Id
OG000
value
7
group Id
OG001
value
2
group Id
OG002
value
7

denoms

counts
group Id
OG000
value
40
group Id
OG001
value
40
group Id
OG002
value
53
units
Participants

description

groups

description
Patients with the following types of soft tissue sarcoma: leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH, MPNST and synovial sarcoma). Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
id
OG000
title
Soft Tissue Sarcoma
description
Patients with the following types of bone sarcoma: Ewing sarcoma, osteosarcoma, and chondrosarcoma \[de-differentiated or mesenchymal\]. Pembrolizumab was administered at 200 mg intravenously every 3 weeks Pembrolizumab
id
OG001
title
Bone Sarcoma
description
Patients with the following types of soft tissue sarcoma: poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma. Pembrolizumab was administered at 200 mg intravenously every 3 weeks
id
OG002
title
Expansion Cohort

param Type

COUNT_OF_PARTICIPANTS

population Description

There were 40 of 42 patients in the soft tissue sarcoma cohort who were evaluable for response. There were 40 of 42 patients in the bone sarcoma cohort who were evaluable for response. There were 53 of 60 patients in the expansion cohort who were evaluable for response.

reporting Status

POSTED

time Frame

Assessments will be conducted at 8 weeks, up to 5 years

title

Objective Response Rate

type

PRIMARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice