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NCT03761914 · OUTCOME

Overall Response Rate (ORR) - Best Overall Response

Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers · Source last updated 2024-11-19

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
33 months

What was measured

Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirements). Best overall response is defined as the best overall visit response in the following order: CR, PR, SD, PD, or UE as measured by RECIST 1.1

Analysis population: Participants who have received at least one dose of pembrolizumab (mITT population). Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.

Groups in this outcome

Ovarian Cancer (OvC)

* Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Colorectal Cancer (CRC)

One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.

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

Analysis denominator · Participants

GroupSource count
Ovarian Cancer (OvC)16
Colorectal Cancer (CRC)0

Reported measurements

Source class 1

Complete response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ovarian Cancer (OvC)0Not reportedNot reportedNot reportedNot reported
Colorectal Cancer (CRC)0Not reportedNot reportedNot reportedNot reported

Partial response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ovarian Cancer (OvC)1Not reportedNot reportedNot reportedNot reported
Colorectal Cancer (CRC)0Not reportedNot reportedNot reportedNot reported

Stable disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ovarian Cancer (OvC)7Not reportedNot reportedNot reportedNot reported
Colorectal Cancer (CRC)0Not reportedNot reportedNot reportedNot reported

Progressive disease

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ovarian Cancer (OvC)8Not reportedNot reportedNot reportedNot reported
Colorectal Cancer (CRC)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      title
      Complete response
    2. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      title
      Partial response
    3. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        0
      title
      Stable disease
    4. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        0
      title
      Progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Percentage of patients who have received at least one dose of pembrolizumab and have responded (and have completed imaging requirements). Best overall response is defined as the best overall visit response in the following order: CR, PR, SD, PD, or UE as measured by RECIST 1.1
groups
  1. description
    * Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab
    id
    OG000
    title
    Ovarian Cancer (OvC)
  2. description
    One subject enrolled but discontinued before efficacy can be assessed. For this reason, this subject was not included in the evaluation for efficacy or safety.
    id
    OG001
    title
    Colorectal Cancer (CRC)
param Type
COUNT_OF_PARTICIPANTS
population Description
Participants who have received at least one dose of pembrolizumab (mITT population). Patients only enrolled in the Ovarian Cancer (OvC) arm. One subject enrolled in the Colorectal Cancer (CRC) arm but discontinued before efficacy can be assessed. The other arms/groups were removed from this study.
reporting Status
POSTED
time Frame
33 months
title
Overall Response Rate (ORR) - Best Overall Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice