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NCT02301039 · OUTCOME

Response Rate by Immune-related Response Criteria (Ir-RC)

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
Assessment at 8 weeks, up to 5 years

What was measured

Immune related response criteria was developed to adequately assess tumor response to immunotherapy.The irRC are based on bidimensional measurements We aimed to assess response by bidimensional measurements in patients with advanced sarcoma. Immune-related Complete Response (irCR) is the complete disappearance of all index lesions. Immune-related Partial Response (irPR) is the decrease by 50% or greater (from Baseline) in the sum of the products of the two largest perpendicular diameters of all index and new measurable lesions

Analysis population: There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 52 out of 60 total patients evaluable for response in the soft tissue sarcoma cohort.

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

GroupSource count
Soft Tissue Sarcoma30
Bone Sarcoma30
Expansion Cohort52

Reported measurements

irCR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Soft Tissue Sarcoma1Not reportedNot reportedNot reportedNot reported
Bone Sarcoma0Not reportedNot reportedNot reportedNot reported
Expansion Cohort2Not reportedNot reportedNot reportedNot reported
irPR
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Soft Tissue Sarcoma2Not reportedNot reportedNot reportedNot reported
Bone Sarcoma2Not reportedNot reportedNot reportedNot reported
Expansion Cohort7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
    title
    irCR
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        7
    title
    irPR
denoms
  1. counts
    1. group Id
      OG000
      value
      30
    2. group Id
      OG001
      value
      30
    3. group Id
      OG002
      value
      52
    units
    Participants
description
Immune related response criteria was developed to adequately assess tumor response to immunotherapy.The irRC are based on bidimensional measurements We aimed to assess response by bidimensional measurements in patients with advanced sarcoma. Immune-related Complete Response (irCR) is the complete disappearance of all index lesions. Immune-related Partial Response (irPR) is the decrease by 50% or greater (from Baseline) in the sum of the products of the two largest perpendicular diameters of all index and new measurable lesions
groups
  1. 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
  2. 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
  3. 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 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 30 out of 40 total patients evaluable for response in the soft tissue sarcoma cohort. There were 52 out of 60 total patients evaluable for response in the soft tissue sarcoma cohort.
reporting Status
POSTED
time Frame
Assessment at 8 weeks, up to 5 years
title
Response Rate by Immune-related Response Criteria (Ir-RC)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice