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NCT04166734 · OUTCOME

Worst Acute Toxicity Grade

Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma · Source last updated 2026-02-04

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
Worst grade as assessed at cycle 1 day 1 of pembrolizumab, at each of three radiotherapy fractions (cycle 1 days 15, 17, 19) and then at day 1 of each 21 day cycle, up to 12 weeks from last dose of SBRT (i.e. cycle 6 day 1)

What was measured

Number of patients by worst recorded grade of acute toxicity, assessed using CTCAE v5.0

Analysis population: All patients who received at least one dose of trial treatment

Groups in this outcome

Initial Safety Cohort

Patients will receive an initial dose of pembrolizumab in week 1 dosed at 200 mg. They will then receive SBRT dosed at 30 Gy in 3 fractions (#) alternate days in week 3. Treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks. Pembrolizumab: Pembrolizumab will be continued dosed at 200 mg given every 3 weeks Drug: Pembrolizumab Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks. Stereotactic Body Radiotherapy (SBRT): Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)

Expansion Cohort

An additional 12 patients will be recruited for this cohort. Patients will receive an initial dose of pembrolizumab at 200 mg in week 1. This will be followed in by SBRT dosed at 30 Gy in 3 fractions (#) alternate days in week 3. Treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks. Pembrolizumab: Pembrolizumab will be continued dosed at 200 mg given every 3 weeks Drug: Pembrolizumab Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks. Stereotactic Body Radiotherapy (SBRT): Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)

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

Analysis denominator · Participants

GroupSource count
Initial Safety Cohort5
Expansion Cohort0

Reported measurements

Source class 1

Max grade 3

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial Safety Cohort3Not reportedNot reportedNot reportedNot reported
Expansion Cohort0Not reportedNot reportedNot reportedNot reported

Max grade 2

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Initial Safety Cohort2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      title
      Max grade 3
    2. measurements
      1. group Id
        OG000
        value
        2
      title
      Max grade 2
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Number of patients by worst recorded grade of acute toxicity, assessed using CTCAE v5.0
groups
  1. description
    Patients will receive an initial dose of pembrolizumab in week 1 dosed at 200 mg. They will then receive SBRT dosed at 30 Gy in 3 fractions (#) alternate days in week 3. Treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks. Pembrolizumab: Pembrolizumab will be continued dosed at 200 mg given every 3 weeks Drug: Pembrolizumab Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks. Stereotactic Body Radiotherapy (SBRT): Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)
    id
    OG000
    title
    Initial Safety Cohort
  2. description
    An additional 12 patients will be recruited for this cohort. Patients will receive an initial dose of pembrolizumab at 200 mg in week 1. This will be followed in by SBRT dosed at 30 Gy in 3 fractions (#) alternate days in week 3. Treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks. Pembrolizumab: Pembrolizumab will be continued dosed at 200 mg given every 3 weeks Drug: Pembrolizumab Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks. Stereotactic Body Radiotherapy (SBRT): Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)
    id
    OG001
    title
    Expansion Cohort
param Type
COUNT_OF_PARTICIPANTS
population Description
All patients who received at least one dose of trial treatment
reporting Status
POSTED
time Frame
Worst grade as assessed at cycle 1 day 1 of pembrolizumab, at each of three radiotherapy fractions (cycle 1 days 15, 17, 19) and then at day 1 of each 21 day cycle, up to 12 weeks from last dose of SBRT (i.e. cycle 6 day 1)
title
Worst Acute Toxicity Grade
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice