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NCT03899805 · OUTCOME

Clinical Benefit Response Rate (CBR)

A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas · Source last updated 2025-08-28

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

Measure
NUMBER
Unit
proportion of participants
Interval / dispersion
90% Confidence Interval
Time frame
Up to 2 years

What was measured

CBR is defined as the proportion of participants who reached stable disease, partical response and complete resposne during treatment based on RECIST 1.1

Groups in this outcome

Liposarcomas

* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.

Leiomyosarcomas

* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.

Undifferentiated Pleomorphic Sarcomas

* Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Liposarcomas20
Leiomyosarcomas19
Undifferentiated Pleomorphic Sarcomas18

Reported measurements

Source class 1
Values in proportion of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Liposarcomas0.75Not reported0.540.90Not reported
Leiomyosarcomas0.53Not reported0.320.73Not reported
Undifferentiated Pleomorphic Sarcomas0.44Not reported0.240.66Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.54
        upper Limit
        0.90
        value
        0.75
      2. group Id
        OG001
        lower Limit
        0.32
        upper Limit
        0.73
        value
        0.53
      3. group Id
        OG002
        lower Limit
        0.24
        upper Limit
        0.66
        value
        0.44
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      19
    3. group Id
      OG002
      value
      18
    units
    Participants
description
CBR is defined as the proportion of participants who reached stable disease, partical response and complete resposne during treatment based on RECIST 1.1
dispersion Type
90% Confidence Interval
groups
  1. description
    * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
    id
    OG000
    title
    Liposarcomas
  2. description
    * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
    id
    OG001
    title
    Leiomyosarcomas
  3. description
    * Participants will receive eribulin intravenously on Day 1 and Day 8 * Pembrolizumab is administered intravenously Day 1, on a 21-day cycle Eribulin: The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis). Pembrolizumab: The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
    id
    OG002
    title
    Undifferentiated Pleomorphic Sarcomas
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 2 years
title
Clinical Benefit Response Rate (CBR)
type
SECONDARY
unit Of Measure
proportion of participants

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

Preserved source evidence · Not medical advice