Trial Outcomes & Findings for PembRolIzuMab and Stereotactic Body Radiotherapy In Metastatic Non-small-cell lunG Cancer Patients (NCT NCT03436056)
NCT ID: NCT03436056
Last Updated: 2026-01-29
Results Overview
Proportion of all treated patients who have experience at least one Dose Limiting Toxicity (DLT). DLT is assessed using NCI CTCAE v4.0 and defined as any one or more of: neutropenia with fever grade \>=3; thrombocytopenia with bleeding grade \>=3; any grade \>=3 non-haematological toxicity which is definitely, probably, or possibly related to the trial treatment.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
2 participants
Primary outcome timeframe
From first dose of Pembrolizumab to 12 weeks from the last dose of lung SBRT
Results posted on
2026-01-29
Participant Flow
During the period between June 2018 and January 2019, 2 patients were recruited to the study at the Royal Marsden Hospital in the United Kingdom.
Participant milestones
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
Pembrolizumab administered as a 30-minute IV infusion.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
Pembrolizumab administered as a 30-minute IV infusion.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
Pembrolizumab administered as a 30-minute IV infusion.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
Pembrolizumab administered as a 30-minute IV infusion.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
Pembrolizumab administered as a 30-minute IV infusion.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
Pembrolizumab administered as a 30-minute IV infusion.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
Baseline Characteristics
PembRolIzuMab and Stereotactic Body Radiotherapy In Metastatic Non-small-cell lunG Cancer Patients
Baseline characteristics by cohort
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
—
|
—
|
0 Participants
n=1267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=41 Participants
|
—
|
—
|
0 Participants
n=1267 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=41 Participants
|
—
|
—
|
2 Participants
n=1267 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
—
|
—
|
1 Participants
n=1267 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=41 Participants
|
—
|
—
|
1 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
—
|
—
|
0 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
—
|
—
|
0 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
—
|
—
|
0 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
—
|
—
|
0 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=41 Participants
|
—
|
—
|
2 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
—
|
—
|
0 Participants
n=1267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
—
|
—
|
0 Participants
n=1267 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=41 Participants
|
—
|
—
|
2 participants
n=1267 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
0 = Normal activity.
|
0 Participants
n=41 Participants
|
—
|
—
|
0 Participants
n=1267 Participants
|
|
Eastern Cooperative Oncology Group (ECOG)
1 = Symptoms but ambulatory.
|
2 Participants
n=41 Participants
|
—
|
—
|
2 Participants
n=1267 Participants
|
PRIMARY outcome
Timeframe: From first dose of Pembrolizumab to 12 weeks from the last dose of lung SBRTPopulation: All patients who completed the DLT period
Proportion of all treated patients who have experience at least one Dose Limiting Toxicity (DLT). DLT is assessed using NCI CTCAE v4.0 and defined as any one or more of: neutropenia with fever grade \>=3; thrombocytopenia with bleeding grade \>=3; any grade \>=3 non-haematological toxicity which is definitely, probably, or possibly related to the trial treatment.
Outcome measures
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Proportion of Patients With Dose Limiting Toxicity
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose of Pembrolizumab to 12 weeks from the last dose of lung SBRTPopulation: All patients who recieved at least one dose of trial treatment
Percentage of patients any acute toxicity, by worst grade as assessed using CTCAE v4.0
Outcome measures
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Acute Toxicity Rate
Patients with max grade 3 toxicity
|
0 Participants
|
—
|
—
|
|
Acute Toxicity Rate
Patients with max grade 2 toxicity
|
1 Participants
|
—
|
—
|
|
Acute Toxicity Rate
Patients with max grade 1 toxicity
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Assessed at start of each 21 day pembrolizumab cycle, starts from 12 weeks after last fraction of lung SBRT and ends 28 days after last on-trial dose of pembrolizumab (treatment ended at disease progression for all trial patients), up to 6 monthsPopulation: All patients who received at least one dose of pembrolizumab and one fraction of radiotherapy
Percentage of patients with any late toxicity, by worst grade as assessed using CTCAE v4.0
Outcome measures
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Late Toxicity Rate
Patients with max grade 3 toxicity
|
1 Participants
|
—
|
—
|
|
Late Toxicity Rate
patients with max grade 2 toxicity
|
0 Participants
|
—
|
—
|
|
Late Toxicity Rate
Patients with max grade 1 toxicity
|
1 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 (occurred no later than 7 months from start of treatment for all patients)Population: All patients with at least one dose of trial treatment
Count of patients with best overall response of complete or partial response at any time, assessed using RECIST v1.1
Outcome measures
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Overall Response Rate
|
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 (occurred no later than 7 months from start of treatment for all patients)Population: All patients with at least one dose of trial treatment
Count of patients with best overall response at any time of complete or partial response, or stable disease, assessed by RECIST v1.1
Outcome measures
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Disease Control Rate
|
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 studyPopulation: No patients were assessed using irRECIST, as the study was terminated early after treating a total of two patients. Although imaging was performed and standard response measurement were done as per RECIST, the sum of the products of the two longest perpendicular diameters as required by irRECIST was not measured.
Count of patients with best response of complete or partial response, assessed using Immune Related Response Criteria (irRC) as defined by: Wolchok JD et al. Guidelines for the evaluation of immune therapy activity in solid tumors: Immune related response criteria. Clin Cancer Res 2009;15(23):7412. (72)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Response to be defined as per previous endpoint, PD1/PD-L1 to be measured at study entryPopulation: The planned tissue evaluation for PD1/PD-L1 status was not done (and will not be performed in future) as the study was terminated early after treating a total of two patients
PD-1/PD-L1 expression distribution in responders and non-responders
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months after last dose of lung SBRTPopulation: All patients assessed for survival at six months following last dose of lung SBRT
Count of patients known to be alive at six months
Outcome measures
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Overall Survival at Six Months
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months after last dose of lung SBRTPopulation: All patients assessed for survival at 12 months
Count of patients known to be alive at 12 months
Outcome measures
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=1 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Overall Survival at 12 Months
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 months after last dose of lung SBRTPopulation: All patients assessed for progression and survival at 6 months
Count of patients known to be alive and free from progression at 6 months
Outcome measures
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Progression Free Survival at 6 Months
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 months after last dose of lung SBRTPopulation: All patients assessed for progression and survival at 12 months
Count of patients known to be alive and free from progression at 12 months
Outcome measures
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 Participants
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Progression Free Survival at 12 Months
|
0 Participants
|
—
|
—
|
Adverse Events
Dose Escalation Cohort - DOSE LEVEL 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dose Escalation Cohort - DOSE LEVEL 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B - Expansion Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dose Escalation Cohort - DOSE LEVEL 1
n=2 participants at risk
Intervention: One dose pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
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.
|
Dose Escalation Cohort - DOSE LEVEL 2
Intervention: One dose of pembrolizumab 200 mg (week 1) followed by lung Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#) in week 3. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#): Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
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.
|
Part B - Expansion Cohort
Intervention: One dose of pembrolizumab 200 mg (week 1) followed in by lung Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose determined in Part A in week 3, dosed at the maximum tolerated dose determined in Part A. Treatment with pembrolizumab 200 mg will be continued given every 3 weeks.
Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose: Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
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.
|
|---|---|---|---|
|
Cardiac disorders
Sinus tachycardia
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Gastrointestinal disorders
Dyspepsia
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 2 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
General disorders
Flu like symptoms
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Infections and infestations
Urinary tract infection
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Infections and infestations
Upper respiratory infection
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Injury, poisoning and procedural complications
Bruising
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
100.0%
2/2 • Number of events 2 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
50.0%
1/2 • Number of events 2 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Nervous system disorders
Dysgeusia
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Renal and urinary disorders
Acute kidney injury
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
2/2 • Number of events 2 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
50.0%
1/2 • Number of events 1 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
—
0/0 • Adverse events were recorded from confirmation of entry into the trial at the start of each 21 day pembrolizumab cycle, until the patients 30 day safety follow up visit. All cause mortality was recorded up to 12 months after last dose of lung SBRT.
No patients were recruited to Dose Level 2 of Dose Escalation Cohort and to Expansion Cohort, therefore number of patients at risk is 0 for these.
|
Additional Information
PRIMING Senior Trial Manager
The Royal Marsden NHS Foundation Trust
Phone: (+44) 02089156666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place