Trial Outcomes & Findings for Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma (NCT NCT04166734)
NCT ID: NCT04166734
Last Updated: 2026-02-04
Results Overview
Dose limiting toxicity is assessed using CTCAE v5.0 and defined as any one of: neutropenia with fever grade\>=3; neutropenia grade\>=4; thrombocytopenia with bleeding grade \>=3; thrombocytopenia grade \>=4; any non-haematological toxicity grade \>=3 which is definitely, probably or possibly related to the combination of pembrolizumab and SBRT
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
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)
Results posted on
2026-02-04
Participant Flow
A total of five participants were recruited to the trial, all to the initial safety cohort. The participants were registered between February 2021 and March 2022.
Participant milestones
| Measure |
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 (#)
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
Commenced Pembrolizumab
|
5
|
0
|
|
Overall Study
Completed 30Gy SBRT in 3 Fractions
|
5
|
0
|
|
Overall Study
Completed 35 Cycles Pembrolizumab
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
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 (#)
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Intercurrent illness
|
1
|
0
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
Pembrolizumab and Hypofractionated Stereotactic Radiotherapy in Patients With Malignant Pleural Mesothelioma
Baseline characteristics by cohort
| Measure |
Initial Safety Cohort
n=5 Participants
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 (#)
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=41 Participants
|
—
|
2 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=41 Participants
|
—
|
3 Participants
n=4626 Participants
|
|
Age, Continuous
|
72 Years
n=41 Participants
|
—
|
72 Years
n=4626 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=41 Participants
|
—
|
2 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=41 Participants
|
—
|
3 Participants
n=4626 Participants
|
|
Race/Ethnicity, Customized
Caucasian (white)
|
5 Participants
n=41 Participants
|
—
|
5 Participants
n=4626 Participants
|
|
Region of Enrollment
United Kingdom
|
5 participants
n=41 Participants
|
—
|
5 participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Patients who remained on trial for the duration of the DLT time frame
Dose limiting toxicity is assessed using CTCAE v5.0 and defined as any one of: neutropenia with fever grade\>=3; neutropenia grade\>=4; thrombocytopenia with bleeding grade \>=3; thrombocytopenia grade \>=4; any non-haematological toxicity grade \>=3 which is definitely, probably or possibly related to the combination of pembrolizumab and SBRT
Outcome measures
| Measure |
Initial Safety Cohort
n=3 Participants
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 (#)
|
|---|---|---|
|
Percentage of Patients With Dose Limiting Toxicity (DLT)
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 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)Population: All patients who received at least one dose of trial treatment
Number of patients by worst recorded grade of acute toxicity, assessed using CTCAE v5.0
Outcome measures
| Measure |
Initial Safety Cohort
n=5 Participants
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 (#)
|
|---|---|---|
|
Worst Acute Toxicity Grade
Max grade 3
|
3 Participants
|
0 Participants
|
|
Worst Acute Toxicity Grade
Max grade 2
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Response assessed from start of pembrolizumab, every 9 weeks for the first 6 months, then every 12 weeks thereafter, until the first instance of documented disease progression, start of new anti-cancer treatment, death or end of study (24 months)Population: All patients who commenced trial treatment and who were assessed at least once for response
Proportion of patients with best recorded response as assessed using RECIST v1.1 of complete or partial response
Outcome measures
| Measure |
Initial Safety Cohort
n=5 Participants
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 (#)
|
|---|---|---|
|
Overall Response Rate
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Response assessed from start of pembrolizumab, every 9 weeks for the first 6 months, then every 12 weeks thereafter, until the first instance of documented disease progression, start of new anti-cancer treatment, death or end of study (24 months)Population: All patients who commenced trial treatment and who were assessed at least once for response
Proportion of patients with best recorded response as assessed using RECIST v1.1 of complete or partial response or stable disease
Outcome measures
| Measure |
Initial Safety Cohort
n=5 Participants
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 (#)
|
|---|---|---|
|
Disease Control Rate
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after start of pembrolizumab treatmentPopulation: All patients who commenced trial treatment and did not withdraw before 6 months
Proportion of patients alive at six months
Outcome measures
| Measure |
Initial Safety Cohort
n=3 Participants
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 (#)
|
|---|---|---|
|
Overall Survival (OS) at Six Months
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months after start of pembrolizumab treatmentPopulation: All patients who commenced trial treatment and did not withdraw before 12 months
Proportion of patients alive at twelve months
Outcome measures
| Measure |
Initial Safety Cohort
n=3 Participants
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 (#)
|
|---|---|---|
|
Overall Survival (OS) at Twelve Months
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 months after commencing pembrolizumab treatmentPopulation: Patients who commenced trial treatment and did not withdraw before progression and before 6 months
Proportion of patients alive and free from progression at six months
Outcome measures
| Measure |
Initial Safety Cohort
n=4 Participants
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 (#)
|
|---|---|---|
|
Progression Free Survival at 6 Months
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months after commencing pembrolizumab treatmentPopulation: Patients who commenced trial treatment and did not withdraw before progression and before 12 months
Proportion of patients alive and free from progression at twelve months
Outcome measures
| Measure |
Initial Safety Cohort
n=4 Participants
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 (#)
|
|---|---|---|
|
Progression Free Survival at 12 Months
|
2 Participants
|
—
|
Adverse Events
Initial Safety Cohort
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Expansion Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Initial Safety Cohort
n=5 participants at risk
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 (#)
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
Other adverse events
| Measure |
Initial Safety Cohort
n=5 participants at risk
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 (#)
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
3/5 • Number of events 4 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Nervous system disorders
Lethargy
|
60.0%
3/5 • Number of events 4 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Weight loss
|
60.0%
3/5 • Number of events 4 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
2/5 • Number of events 4 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Metabolism and nutrition disorders
Anorexia
|
40.0%
2/5 • Number of events 2 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Aspartate aminotransferase increased
|
40.0%
2/5 • Number of events 4 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Number of events 2 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Number of events 4 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2 • 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).
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.
|
—
0/0 • 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).
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.
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 3 • 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).
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.
|
—
0/0 • 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).
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.
|
|
General disorders
Fever
|
40.0%
2/5 • Number of events 2 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Alkaline phosphatase increased
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
20.0%
1/5 • Number of events 3 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
1/5 • Number of events 2 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Blood lactate dehydrogenase increased
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
20.0%
1/5 • Number of events 2 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
General disorders
Flu like symptoms
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Vascular disorders
Hypertension
|
20.0%
1/5 • Number of events 4 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Investigations - other, increased C-reactive protein
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Investigations - other, increased lactate
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Eye disorders
Papilledema
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
20.0%
1/5 • Number of events 3 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
1/5 • Number of events 2 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
|
Investigations
Investigations - other, raised urea
|
20.0%
1/5 • Number of events 1 • 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).
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.
|
—
0/0 • 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).
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.
|
Additional Information
MESO-PRIME Trial Manager
The Royal Marsden NHS Foundation Trust
Phone: (+44)2089156666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place