Trial Outcomes & Findings for Pembrolizumab and Palliative Radiotherapy in Lung (NCT NCT02587455)
NCT ID: NCT02587455
Last Updated: 2026-04-23
Results Overview
DLT period is defined as the interval of 2 months following the final fraction of RT (at the beginning of cycle 4), using CTCAE v4.0 for acute toxicity. For this study a DLT would be regarded as any event of pneumonitis at ≥ grade 2. DLTs were collected to determine the Maximum-Tolerated Dose (MTD). The toxicity rate will be stated as the proportion of patients who have had a DLT calculated with a 95% confidence interval.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
2 months following the final fraction of RT
Results posted on
2026-04-23
Participant Flow
The study opened to recruitment in June 2016. Recruitment closed in April 2020. All participants were enrolled at the Royal Marsden NHS Foundation Trust in the United Kingdom. Twenty-one patients were recruited as part of the dose escalation phase (3+3 design) and an additional three participants were treated at the MTD during the dose escalation phase.
Participant milestones
| Measure |
100mg Pembro & Low Dose RT
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
3
|
7
|
|
Overall Study
COMPLETED
|
6
|
6
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
100mg Pembro & Low Dose RT
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Overall Study
Disease Progression
|
0
|
2
|
0
|
0
|
|
Overall Study
Non-compliance
|
0
|
0
|
0
|
1
|
Baseline Characteristics
PD-L1 status is available only for 21 out of 24 enrolled participants.
Baseline characteristics by cohort
| Measure |
100mg Pembro & Low Dose RT
n=6 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=7 Participants
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
Total
n=24 Participants
Total of all reporting groups
|
100mg Pembro & High Dose RT
n=8 Participants
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 Participants
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
|---|---|---|---|---|---|
|
Age, Continuous
|
65 years
n=6 Participants
|
61 years
n=7 Participants
|
67 years
n=24 Participants
|
65 years
n=8 Participants
|
71 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=24 Participants
|
6 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=24 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
6 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
21 Participants
n=24 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
African/Caribbean
|
0 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United Kingdom
|
6 Participants
n=6 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=24 Participants
|
8 Participants
n=8 Participants
|
3 Participants
n=3 Participants
|
|
Smoking status
Never smoker
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=3 Participants
|
|
Smoking status
Ex-smoker
|
5 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=24 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
|
Smoking status
Current smoker
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
|
Type of NSCLC
Squamous
|
3 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=24 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=3 Participants
|
|
Type of NSCLC
Adenocarcinoma
|
3 Participants
n=6 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=24 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=3 Participants
|
|
PD-L1 status
Strong (≥50%)
|
1 Participants
n=5 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
1 Participants
n=6 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
7 Participants
n=21 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
4 Participants
n=7 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
1 Participants
n=3 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
|
PD-L1 status
Non-strong (<50%)
|
4 Participants
n=5 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
5 Participants
n=6 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
14 Participants
n=21 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
3 Participants
n=7 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
2 Participants
n=3 Participants • PD-L1 status is available only for 21 out of 24 enrolled participants.
|
PRIMARY outcome
Timeframe: 2 months following the final fraction of RTPopulation: DLT population consisting of all eligible patients who received at least one dose of Pembrolizumab AND at least one fraction of radiotherapy AND complete the DLT period of 2 months following the final fraction of RT. 18 patients were included in the DLT population from the dose escalation phase. This was presented for all participants in the DLT population of the dose escalation phase as per the signed statistical analysis plan and final study report. Please note there were 0 DLTs recorded.
DLT period is defined as the interval of 2 months following the final fraction of RT (at the beginning of cycle 4), using CTCAE v4.0 for acute toxicity. For this study a DLT would be regarded as any event of pneumonitis at ≥ grade 2. DLTs were collected to determine the Maximum-Tolerated Dose (MTD). The toxicity rate will be stated as the proportion of patients who have had a DLT calculated with a 95% confidence interval.
Outcome measures
| Measure |
100mg Pembro & Low Dose RT
n=6 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=6 Participants
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 Participants
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=3 Participants
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Toxicity Rate of Dose Limiting Toxicities (DLTs) Assessed by CTCAEv4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 months following the final fraction of RTPopulation: DLT population consisting of of all eligible patients who received at least one dose of Pembrolizumab AND at least one fraction of radiotherapy AND complete the DLT period of 2 months following the final fraction of RT. 18 patients were included in the DLT population from the dose escalation phase. This was presented for all participants in the DLT population of the dose escalation phase as per the signed statistical analysis plan and final study report. Please note there were 0 DLTs recorded.
MTD was determined by testing increasing doses of pembrolizumab (100mg / 200mg) and low/high doses of RT. MTD reflects the highest dose in the absence of a DLT. The DLT period is defined as the interval of 2 months following the final fraction of RT (at the beginning of cycle 4), using CTCAE v4.0 for acute toxicity. For this study a DLT would be regarded as any event of pneumonitis at ≥ grade 2.
Outcome measures
| Measure |
100mg Pembro & Low Dose RT
n=18 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of Pembrolizumab That Can be Safely Combined With Radiotherapy (RT) in the Absence of Dose Limiting Toxicity (DLT) Assessed by CTCAEv4
|
200 mg
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Evaluable population consisting of all eligible patients who received at least one dose of Pembrolizumab AND at least one fraction of radiotherapy. All 24 participants were evaluable for PFS analysis.
Progression-free survival (PFS) will be measured from the start of RT until radiological or clinical evidence of progression or else death from any cause. Any progression free surviving patients will be censored at last follow-up date. Using Kaplan-Meier methods, PFS rates at 6 months and 1 year will be reported with 95% confidence intervals.
Outcome measures
| Measure |
100mg Pembro & Low Dose RT
n=6 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=8 Participants
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 Participants
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=7 Participants
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Progression Free Survival at 6 and 12 Months
6 month PFS
|
NA percentage of participants
insufficient number of participants with events
|
50.0 percentage of participants
Interval 15.2 to 77.5
|
NA percentage of participants
insufficient number of participants with events
|
42.9 percentage of participants
Interval 9.8 to 73.4
|
|
Progression Free Survival at 6 and 12 Months
12 month PFS
|
NA percentage of participants
insufficient number of participants with events
|
25.0 percentage of participants
Interval 3.7 to 55.8
|
NA percentage of participants
insufficient number of participants with events
|
42.9 percentage of participants
Interval 9.8 to 73.4
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Evaluable population consisting of all eligible patients who received at least one dose of Pembrolizumab AND at least one fraction of radiotherapy. All 24 patients were included in the analysis.
Overall survival (OS) will be measured from the start of RT until death from any cause; any surviving patients will be censored at last follow-up date. Using Kaplan-Meier methods, survival rates at 6 months and 1 year will be reported with 95% confidence intervals.
Outcome measures
| Measure |
100mg Pembro & Low Dose RT
n=6 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=8 Participants
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 Participants
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=7 Participants
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Overall Survival at 6 and 12 Months
6 month OS
|
50.0 percentage of participants
Interval 11.1 to 80.4
|
87.5 percentage of participants
Interval 38.7 to 98.1
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
71.4 percentage of participants
Interval 25.8 to 92.0
|
|
Overall Survival at 6 and 12 Months
12 month OS
|
33.3 percentage of participants
Interval 4.6 to 67.6
|
37.5 percentage of participants
Interval 8.7 to 67.4
|
NA percentage of participants
insufficient number of participants with events
|
42.9 percentage of participants
Interval 9.8 to 73.4
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Evaluable population consisting of all eligible patients who received at least one dose of Pembrolizumab AND at least one fraction of radiotherapy. Only patients with PD-L1 status available have been analysed.
PD-L1 staining is referred to as tumour proportion score, reported as a percentage from 0-100%. A PDL1 strong population will be those who have a tumour proportion score of \>/=50%. Using Kaplan-Meier methods, survival rates at 6 months and 1 year for each PDL1 subgroup will be reported with 95% confidence intervals.
Outcome measures
| Measure |
100mg Pembro & Low Dose RT
n=5 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=7 Participants
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 Participants
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=6 Participants
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
PFS at 6 and 12 Months by PDL-1 Status (Strong vs Non-strong)
6 month PFS - PDL1 Strong
|
NA percentage of participants
insufficient number of participants with events
|
50.0 percentage of participants
Interval 5.8 to 84.5
|
NA percentage of participants
insufficient number of participants with events
|
100 percentage of participants
insufficient number of participants with events
|
|
PFS at 6 and 12 Months by PDL-1 Status (Strong vs Non-strong)
6 month PFS - PDL1 Non-strong
|
NA percentage of participants
insufficient number of participants with events
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
NA percentage of participants
insufficient number of participants with events
|
20.0 percentage of participants
Interval 8.4 to 58.2
|
|
PFS at 6 and 12 Months by PDL-1 Status (Strong vs Non-strong)
12 month PFS - PDL1 Strong
|
NA percentage of participants
insufficient number of participants with events
|
25.0 percentage of participants
Interval 8.9 to 66.5
|
NA percentage of participants
insufficient number of participants with events
|
100 percentage of participants
insufficient number of participants with events
|
|
PFS at 6 and 12 Months by PDL-1 Status (Strong vs Non-strong)
12 month PFS - PDL1 Non-strong
|
NA percentage of participants
insufficient number of participants with events
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
NA percentage of participants
insufficient number of participants with events
|
20.0 percentage of participants
Interval 0.8 to 58.2
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Evaluable population consisting of all eligible patients who received at least one dose of Pembrolizumab AND at least one fraction of radiotherapy. Only patients with PDL1 data will be analysed.
PD-L1 staining is referred to as tumour proportion score, reported as a percentage from 0-100%. A PDL1 strong population will be those who have a tumour proportion score of \>/=50%. Using Kaplan-Meier methods, survival rates at 6 months and 1 year for each PDL1 subgroup will be reported with 95% confidence intervals.
Outcome measures
| Measure |
100mg Pembro & Low Dose RT
n=5 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=7 Participants
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 Participants
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=6 Participants
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
OS at 6 and 12 Months by PDL-1 Status (Strong vs Non-strong)
6 month OS - PDL1 Strong
|
NA percentage of participants
insufficient number of participants with events
|
75.0 percentage of participants
Interval 12.8 to 96.1
|
100 percentage of participants
insufficient number of participants with events
|
100 percentage of participants
insufficient number of participants with events
|
|
OS at 6 and 12 Months by PDL-1 Status (Strong vs Non-strong)
6 month OS - PDL1 Non-Strong
|
50.0 percentage of participants
Interval 5.8 to 84.5
|
100 percentage of participants
insufficient number of participants with events
|
NA percentage of participants
insufficient number of participants with events
|
60.0 percentage of participants
Interval 12.6 to 88.2
|
|
OS at 6 and 12 Months by PDL-1 Status (Strong vs Non-strong)
12 month OS - PDL1 Strong
|
NA percentage of participants
insufficient number of participants with events
|
25.0 percentage of participants
Interval 8.9 to 66.5
|
NA percentage of participants
insufficient number of participants with events
|
100 percentage of participants
insufficient number of participants with events
|
|
OS at 6 and 12 Months by PDL-1 Status (Strong vs Non-strong)
12 month OS - PDL1 Non-Strong
|
25.0 percentage of participants
Interval 8.9 to 66.5
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
NA percentage of participants
insufficient number of participants with events
|
20.0 percentage of participants
Interval 8.4 to 58.2
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Evaluable population consisting of all eligible patients who received at least one dose of Pembrolizumab AND at least one fraction of radiotherapy. Only those participants who achieved a response will be included.
Progression-free survival (PFS2) will be measured from the first response (defined as CR or PR or SD using RECIST v1.1) until radiological or clinical evidence of progression or else death from any cause (also known as "duration of clinical benefit"). Any patients not experiencing a response will not be included, and any progression free surviving patients will be censored at last follow-up date. Using Kaplan-Meier methods, PFS2 rates at 6 months and 1 year will be reported with 95% confidence intervals.
Outcome measures
| Measure |
100mg Pembro & Low Dose RT
n=3 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=5 Participants
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 Participants
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=5 Participants
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Progression Free Survival (PFS2) From Date of First Response at 6 and 12 Months
6 month PFS2
|
NA percentage of participants
insufficient number of participants with events
|
60.0 percentage of participants
Interval 12.6 to 88.2
|
NA percentage of participants
insufficient number of participants with events
|
60.0 percentage of participants
Interval 12.6 to 88.2
|
|
Progression Free Survival (PFS2) From Date of First Response at 6 and 12 Months
12 month PFS2
|
NA percentage of participants
insufficient number of participants with events
|
40.0 percentage of participants
Interval 5.2 to 75.3
|
NA percentage of participants
insufficient number of participants with events
|
40.0 percentage of participants
Interval 5.2 to 75.3
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPopulation: Evaluable population consisting of all eligible patients who received at least one dose of Pembrolizumab AND at least one fraction of radiotherapy. Only patients who achieved a response will be included in this analysis.
Progression-free survival (PFS2) will be measured from the first response (defined as CR or PR or SD using RECIST v1.1) until radiological or clinical evidence of progression or else death from any cause (also known as "duration of clinical benefit"). Any patients not experiencing a response will not be included, and any progression free surviving patients will be censored at last follow-up date. Using Kaplan-Meier methods, PFS2 rates at 6 months and 1 year for each histological subgroup (squamous vs non-squamous) will be reported with 95% confidence intervals.
Outcome measures
| Measure |
100mg Pembro & Low Dose RT
n=3 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=5 Participants
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 Participants
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=5 Participants
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
PFS2 (From Date of First Response) by Histological Sub-types (Squamous vs Non-squamous)
6 month PFS2: Squamous
|
NA percentage of participants
insufficient number of participants with events
|
100 percentage of participants
insufficient number of participants with events
|
NA percentage of participants
insufficient number of participants with events
|
100 percentage of participants
insufficient number of participants with events
|
|
PFS2 (From Date of First Response) by Histological Sub-types (Squamous vs Non-squamous)
6 month PFS2: Adenocarcinoma
|
NA percentage of participants
insufficient number of participants with events
|
33.3 percentage of participants
Interval 0.9 to 77.4
|
NA percentage of participants
insufficient number of participants with events
|
50.0 percentage of participants
Interval 5.8 to 84.5
|
|
PFS2 (From Date of First Response) by Histological Sub-types (Squamous vs Non-squamous)
12 month PFS2: Squamous
|
NA percentage of participants
insufficient number of participants with events
|
100 percentage of participants
insufficient number of participants with events
|
NA percentage of participants
insufficient number of participants with events
|
100 percentage of participants
insufficient number of participants with events
|
|
PFS2 (From Date of First Response) by Histological Sub-types (Squamous vs Non-squamous)
12 month PFS2: Adenocarcinoma
|
NA percentage of participants
insufficient number of participants with events
|
NA percentage of participants
insufficient number of participants with events
|
NA percentage of participants
insufficient number of participants with events
|
25.0 percentage of participants
Interval 0.9 to 66.5
|
SECONDARY outcome
Timeframe: two months after the last fraction of RTPopulation: Evaluable population consisting of all eligible patients who received at least one dose of Pembrolizumab AND at least one fraction of radiotherapy.
Oesophagitis events will be determined by CTCAE v4.0. Proportion of patients with oesophagitis grade 2+ will be summarised with associated 95% confidence interval.
Outcome measures
| Measure |
100mg Pembro & Low Dose RT
n=6 Participants
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=8 Participants
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 Participants
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=7 Participants
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Oesophagitis Rates Assessed at Two Months After the Last Fraction of RT Has Been Administered
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
0 percentage of participants
Interval to 70.8
NA=0 (97.5% one-sided)
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
Adverse Events
100mg Pembro & Low Dose RT
Serious events: 0 serious events
Other events: 6 other events
Deaths: 6 deaths
100mg Pembro & High Dose RT
Serious events: 1 serious events
Other events: 8 other events
Deaths: 8 deaths
200mg Pembro & Low Dose RT
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
200mg Pembro & High Dose RT (MTD)
Serious events: 5 serious events
Other events: 7 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
100mg Pembro & Low Dose RT
n=6 participants at risk
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=8 participants at risk
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 participants at risk
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=7 participants at risk
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Bronchial infection
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Investigations
Other, Drug induced liver injury
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
42.9%
3/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
Other adverse events
| Measure |
100mg Pembro & Low Dose RT
n=6 participants at risk
Dose level 1 with Low Dose RT Arm (100mg Pembrolizumab \& Low dose radiotherapy): 100mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
100mg Pembro & High Dose RT
n=8 participants at risk
Dose Level 1 with High Dose RT Arm (100mg pembrolizumab \& high dose radiotherapy): 100mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr).
|
200mg Pembro & Low Dose RT
n=3 participants at risk
Dose Level 2 with Low Dose RT Arm (200mg pembrolizumab \& low dose radiotherapy): 200mg every 2 weeks at Week 0 and Week 2 then followed by maintenance dose of 200mg every 3 weeks starting at week 5. RT low dose given at week 2 (20Gy 5Fr).
|
200mg Pembro & High Dose RT (MTD)
n=7 participants at risk
Dose Level 2 with High Dose RT Arm (200mg pembrolizumab \& High dose radiotherapy): 200mg every 2 weeks at Week 0, Week 2 and Week 4 then followed by maintenance dose of 200mg every 3 weeks starting at week 6. RT high dose given at weeks 2,3 \& 4 (36Gy 12Fr). This was declared the maximum tolerated dose (MTD).
|
|---|---|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
3/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
66.7%
2/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
General disorders
Pain
|
33.3%
2/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Aphonia
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Cardiac disorders
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Eye disorders
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
37.5%
3/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
3/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
28.6%
2/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
37.5%
3/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Bronchial infection
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
50.0%
4/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
28.6%
2/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
66.7%
4/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
50.0%
4/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
66.7%
2/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
General disorders
Chills
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
50.0%
4/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
28.6%
2/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Endocrine disorders
Cushingoid
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
66.7%
4/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
100.0%
8/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
66.7%
2/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
42.9%
3/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
50.0%
4/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
28.6%
2/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Dysphagia
|
50.0%
3/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
50.0%
4/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
3/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
37.5%
3/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
66.7%
2/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
General disorders
Edema limbs
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
General disorders
Edema trunk
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Esophageal infection
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Esophagitis
|
50.0%
3/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
62.5%
5/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
28.6%
2/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
General disorders
Facial pain
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
General disorders
Fatigue
|
50.0%
3/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
75.0%
6/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
General disorders
Flu like symptoms
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Investigations
GGT increased
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Vascular disorders
Hematoma
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
2/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
62.5%
5/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
28.6%
2/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Mucosal infection
|
33.3%
2/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
37.5%
3/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
37.5%
3/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
62.5%
5/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
42.9%
3/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
General disorders
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Investigations
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Metabolism and nutrition disorders
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
28.6%
2/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Psychiatric disorders
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Other
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Other
|
50.0%
3/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
28.6%
2/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Eye disorders
Pappiledema
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
33.3%
2/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
75.0%
6/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
66.7%
2/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Presyncope
|
33.3%
2/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
50.0%
4/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
28.6%
2/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Seizure
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Syncope
|
33.3%
2/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
37.5%
3/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Eye disorders
Uveitis
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Vascular disorders
Visceral arterial ischemia
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
37.5%
3/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Investigations
Weight loss
|
16.7%
1/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
25.0%
2/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
33.3%
1/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
14.3%
1/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
|
Nervous system disorders
Other
|
0.00%
0/6 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
12.5%
1/8 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/3 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
0.00%
0/7 • AEs were recorded from first dose of pembrolizumab until the patients 30 days safety follow-up visit following end of treatment (max duration 28 months). All-cause mortality was assessed until end of study (max 2 years post end of treatment).
|
Additional Information
PEAR Trial Manager
The Royal Marsden NHS Foundation Trust
Phone: +442089156666
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place