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NCT02538510 · OUTCOME

Objective Response Rate

Pembrolizumab and Vorinostat in Treating Patients With Recurrent Squamous Cell Head and Neck Cancer or Salivary Gland Cancer That Is Metastatic and/or Cannot Be Removed by Surgery · Source last updated 2024-11-26

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
Up to 2 years

What was measured

Radiologic assessments of measurable disease will be performed using radiographic imaging. RECIST 1.1 and immune response criteria will be used to assess response to therapy. Responses will be summarized as frequencies and percentages.

Analysis population: 6 patients were not evaluated as they did not have at least 1 set of follow up scans while on study, (N=2 salivary patients, N=4 SCC patients)

Groups in this outcome

Head and Neck Squamous Cell

Head and Neck Squamous Cell RECIST 1.1

Salivary Gland Carcinoma

RECIST 1.1 response rate salivary gland

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

Analysis denominator · Participants

GroupSource count
Head and Neck Squamous Cell21
Salivary Gland Carcinoma23

Reported measurements

partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell8Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma4Not reportedNot reportedNot reportedNot reported
stable disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell8Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma13Not reportedNot reportedNot reportedNot reported
progressive disease
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Head and Neck Squamous Cell5Not reportedNot reportedNot reportedNot reported
Salivary Gland Carcinoma6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        4
    title
    partial response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        13
    title
    stable disease
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        6
    title
    progressive disease
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      23
    units
    Participants
description
Radiologic assessments of measurable disease will be performed using radiographic imaging. RECIST 1.1 and immune response criteria will be used to assess response to therapy. Responses will be summarized as frequencies and percentages.
groups
  1. description
    Head and Neck Squamous Cell RECIST 1.1
    id
    OG000
    title
    Head and Neck Squamous Cell
  2. description
    RECIST 1.1 response rate salivary gland
    id
    OG001
    title
    Salivary Gland Carcinoma
param Type
COUNT_OF_PARTICIPANTS
population Description
6 patients were not evaluated as they did not have at least 1 set of follow up scans while on study, (N=2 salivary patients, N=4 SCC patients)
reporting Status
POSTED
time Frame
Up to 2 years
title
Objective Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice