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NCT04166734 · ADVERSE EVENTS

Adverse events

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
AEs will be graded and recorded from confirmation of entry into the trial, 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, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 10 months). All cause mortality is recorded until death or end of trial (24 months).
Other-event reporting threshold
0%

Adverse events were assessed using CTCAE v5.0. Disease progression of the cancer under study is not considered an AE unless the investigator considers it to be IMP-related or it results in hospitalisation or prolongs existing in-patient hospitalisation or death.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
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 (#)

3 / 55 / 52 / 5
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 (#)

0 / 00 / 00 / 0

Group identifiers: EG000: Initial Safety Cohort · EG001: Expansion Cohort

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Flank pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Lung infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Pneumonitis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Dyspnea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Lethargy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Weight loss
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num At Risk
      0
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num At Risk
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Cough
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num At Risk
      0
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      3
    2. group Id
      EG001
      num At Risk
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num At Risk
      0
    term
    Fever
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Alkaline phosphatase increased
Complete source fields
description
Adverse events were assessed using CTCAE v5.0. Disease progression of the cancer under study is not considered an AE unless the investigator considers it to be IMP-related or it results in hospitalisation or prolongs existing in-patient hospitalisation or death.
event Groups
  1. deaths Num Affected
    2
    deaths Num At Risk
    5
    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
    EG000
    other Num Affected
    5
    other Num At Risk
    5
    serious Num Affected
    3
    serious Num At Risk
    5
    title
    Initial Safety Cohort
  2. deaths Num Affected
    0
    deaths Num At Risk
    0
    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
    EG001
    other Num Affected
    0
    other Num At Risk
    0
    serious Num Affected
    0
    serious Num At Risk
    0
    title
    Expansion Cohort
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Dyspnea
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Lethargy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Weight loss
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Alanine aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num At Risk
      0
    term
    Anorexia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Aspartate aminotransferase increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num At Risk
      0
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      4
    2. group Id
      EG001
      num At Risk
      0
    term
    Cough
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num At Risk
      0
    term
    Diarrhea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      3
    2. group Id
      EG001
      num At Risk
      0
    term
    Fatigue
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      5
      num Events
      2
    2. group Id
      EG001
      num At Risk
      0
    term
    Fever
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Alkaline phosphatase increased
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Constipation
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Flank pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Alanine aminotransferase increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Aspartate aminotransferase increased
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Lung infection
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (5.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      5
      num Events
      1
    2. group Id
      EG001
      num At Risk
      0
    term
    Pneumonitis
time Frame
AEs will be graded and recorded from confirmation of entry into the trial, 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, until the patients final safety follow up at 30 days after their last dose of pembrolizumab (up to 10 months). All cause mortality is recorded until death or end of trial (24 months).

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