MedTrace Logo

Trial Outcomes & Findings for Trial of Pembrolizumab and Radiotherapy in Melanoma (NCT NCT02562625)

NCT ID: NCT02562625

Last Updated: 2026-04-23

Results Overview

Percentage of patients with improved tumour response rate (CR/PR) according to the RECIST v1.1 criteria at 12 weeks post treatment start date with the combination therapy of pembrolizumab plus radiotherapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

From date of randomisation until week 12 from start of treatment

Results posted on

2026-04-23

Participant Flow

During the period between August 2016 and April 2018, 17 patients were recruited to the study at nine sites across the United Kingdom.

Participant milestones

Participant milestones
Measure
Pembrolizumab Alone
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Pembrolizumab Plus Radiotherapy
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Overall Study
STARTED
8
9
Overall Study
COMPLETED
0
1
Overall Study
NOT COMPLETED
8
8

Reasons for withdrawal

Reasons for withdrawal
Measure
Pembrolizumab Alone
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Pembrolizumab Plus Radiotherapy
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Overall Study
Physician Decision
0
1
Overall Study
Adverse Event
0
1
Overall Study
Death
0
1
Overall Study
Lack of Efficacy
5
5
Overall Study
Withdrawal by Subject
1
0
Overall Study
Intercurrent illness
2
0

Baseline Characteristics

Trial of Pembrolizumab and Radiotherapy in Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Pembrolizumab Alone
n=8 Participants
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Pembrolizumab Plus Radiotherapy
n=9 Participants
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Total
n=17 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
Age, Categorical
Between 18 and 65 years
1 Participants
n=60 Participants
3 Participants
n=56 Participants
4 Participants
n=116 Participants
Age, Categorical
>=65 years
7 Participants
n=60 Participants
6 Participants
n=56 Participants
13 Participants
n=116 Participants
Sex: Female, Male
Female
3 Participants
n=60 Participants
6 Participants
n=56 Participants
9 Participants
n=116 Participants
Sex: Female, Male
Male
5 Participants
n=60 Participants
3 Participants
n=56 Participants
8 Participants
n=116 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
Race (NIH/OMB)
Asian
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
Race (NIH/OMB)
White
8 Participants
n=60 Participants
9 Participants
n=56 Participants
17 Participants
n=116 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=60 Participants
0 Participants
n=56 Participants
0 Participants
n=116 Participants
Region of Enrollment
United Kingdom
8 participants
n=60 Participants
9 participants
n=56 Participants
17 participants
n=116 Participants
Eastern Cooperative Oncology Group (ECOG)
0 = Normal activity
4 Participants
n=60 Participants
5 Participants
n=56 Participants
9 Participants
n=116 Participants
Eastern Cooperative Oncology Group (ECOG)
1 = Symptoms but ambulatory
4 Participants
n=60 Participants
4 Participants
n=56 Participants
8 Participants
n=116 Participants

PRIMARY outcome

Timeframe: From date of randomisation until week 12 from start of treatment

Population: Intention to treat (ITT) analysis population.

Percentage of patients with improved tumour response rate (CR/PR) according to the RECIST v1.1 criteria at 12 weeks post treatment start date with the combination therapy of pembrolizumab plus radiotherapy.

Outcome measures

Outcome measures
Measure
Pembrolizumab Plus Radiotherapy
n=9 Participants
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Pembrolizumab Alone
n=8 Participants
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Objective: To Evaluate if Radiotherapy Will Enhance the Efficacy of Pembrolizumab in the Treatment of Patients With Metastatic Melanoma by Induction of an Abscopal Effect.
3 Participants
1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: RECIST tumour assessments completed at screening and every 12 weeks after 1st dose of pembrolizumab or during additional imaging time points and at early termination of treatment until date of first documented progression or end of trial (36 months).

Population: Intention to treat (ITT) analysis population

Percentage of improved turmour response rate (CR/PR) according to the RECIST v1.1 criteria post treatment.

Outcome measures

Outcome measures
Measure
Pembrolizumab Plus Radiotherapy
n=9 Participants
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Pembrolizumab Alone
n=8 Participants
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Evaluating Response Rates by RECIST v1.1 Post Treatment
3 Participants
1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first.

Population: ITT patient population. Data not available for this outcome, the planned laboratory work was not performed as the smaller than planned sample size meant this was not thought to be useful.

Description of biomarker levels in the evaluable patients by laboratory results from immunohistochemistry tumour samples analysis.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first.

Population: All non-irradiated lesions identified at screening and assessed post randomisation. The data records showed no patient had non-irradiated lesions.

Proportion of non-irradiated lesions that achieved RECIST 1.1 response (CR/PR) during the study follow-up from randomisation up to 60 months.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: RECIST tumour assessments completed every 12 weeks after 1st dose of pembrolizumab or during additional imaging time points and at early termination of treatment until date of first documented progression, date of death or end of trial (36 months).

Population: Intention to treat (ITT) analysis population.

Percentage of patients alive and progression free at 6, 12 and 24 months post randomisation.

Outcome measures

Outcome measures
Measure
Pembrolizumab Plus Radiotherapy
n=9 Participants
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Pembrolizumab Alone
n=8 Participants
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Assessing the Efficacy of Pembrolizumab Based on Progression Free Survival (PFS).
PFS rate at 24 months
33.3 Percentage of participants
Interval 7.8 to 62.3
0 Percentage of participants
Interval 0.0 to 0.0
Assessing the Efficacy of Pembrolizumab Based on Progression Free Survival (PFS).
PFS rate at 6 months
44.4 Percentage of participants
Interval 13.6 to 71.9
25.0 Percentage of participants
Interval 3.7 to 55.8
Assessing the Efficacy of Pembrolizumab Based on Progression Free Survival (PFS).
PFS rate at 12 months
33.3 Percentage of participants
Interval 7.8 to 62.3
25.0 Percentage of participants
Interval 3.7 to 55.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Overall survival time are from date of randomisation until the date of death from any cause. Patients survival status are assessed post treatment end every 12 weeks from safety follow-up visit 30 days until death or end of trial (36 months)

Population: Intention to treat (ITT) analysis population. No patients in follow-up at 60 months post radiotherapy.

Percentage of patients alive at six, twelve and twenty four months post randomisation into the trial.

Outcome measures

Outcome measures
Measure
Pembrolizumab Plus Radiotherapy
n=9 Participants
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Pembrolizumab Alone
n=8 Participants
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Assessing the Efficacy of Pembrolizumab Based on Overall Survival (OS).
Overall Survival Rate at 12 months
66.7 Percentage of participants
Interval 28.2 to 87.8
75.9 Percentage of participants
Interval 31.5 to 93.1
Assessing the Efficacy of Pembrolizumab Based on Overall Survival (OS).
Overall Survival Rate at 24 months
55.6 Percentage of participants
Interval 20.4 to 80.5
56.3 Percentage of participants
Interval 14.7 to 84.2
Assessing the Efficacy of Pembrolizumab Based on Overall Survival (OS).
Overall Survival (OS) Rate at 6 months
77.8 Percentage of participants
Interval 36.5 to 93.4
100.0 Percentage of participants
There are no or insufficient number of patients with events to calculate the 95% CI at 100% overall survival rate

OTHER_PRE_SPECIFIED outcome

Timeframe: AEs recorded from entry, at day 1 of each cycle, until final safety follow up at 30 days post last dose (up to 12 months). RT toxicities recorded weekly, late toxicities 3 month, then 6 monthly until 24 months.

Population: All patients who received at least one dose of pembrolizumab and assessed for CTCAE toxicities. And all patients who received at least one dose of radiotherapy and who were assessed for RTOG toxicity at week 12 timepoint. Four patients in the pembrolizumab plus radiotherapy arm were omitted from this population as they were not assessed for RTOG toxicity at the required timepoint.

Data for this outcome were collected for all patients in the two arms using common terminology criteria for adverse events (CTCAE) for the assessment of toxicities grades from grade 1 (mild toxicity) to grade 5 (maximum severe toxicity) events. Then using radiation toxicity grading (RTOG) for late effects of normal tissue - subjective objective management analytical (LENT - SOMA) scale were collected separately to assess late radiotherapy toxicities for patient randomised to received pembrolizumab in combination with radiotherapy. Results are reported in similar way, separately for CTCAE toxicities as the number of patients who experienced any toxicity grade 1 and above. And RTOG as number of patients who had any grade 1 and above toxicities.

Outcome measures

Outcome measures
Measure
Pembrolizumab Plus Radiotherapy
n=9 Participants
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Pembrolizumab Alone
n=8 Participants
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Assessing the Safety and Tolerability of Pembrolizumab Alone and in Combination With High Dose Radiotherapy.
CTCAE TERM categorised AEs : Patients with grade 1 and above
9 Participants
8 Participants
Assessing the Safety and Tolerability of Pembrolizumab Alone and in Combination With High Dose Radiotherapy.
CTCAE TERM categorised AEs : Patients with grade 3 and above
0 Participants
1 Participants
Assessing the Safety and Tolerability of Pembrolizumab Alone and in Combination With High Dose Radiotherapy.
RTOG (LENT SOMA) scale toxicities : Patients with grade 1 and above
4 Participants
—
Assessing the Safety and Tolerability of Pembrolizumab Alone and in Combination With High Dose Radiotherapy.
RTOG (LENT SOMA) scale toxicities : Patients with grade 3 and above
0 Participants
—

Adverse Events

Pembrolizumab Alone

Serious events: 0 serious events
Other events: 8 other events
Deaths: 5 deaths

Pembrolizumab Plus Radiotherapy

Serious events: 4 serious events
Other events: 9 other events
Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure
Pembrolizumab Alone
n=8 participants at risk
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Pembrolizumab Plus Radiotherapy
n=9 participants at risk
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Infections and infestations
Sepsis
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Endocrine disorders
Hypophysitis related to hypopituitarism
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Nervous system disorders
Brain metastases
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).

Other adverse events

Other adverse events
Measure
Pembrolizumab Alone
n=8 participants at risk
If the patient is randomised to the Pembrolizumab Arm Only then they will receive 200mg of pembrolizumab every 3 weeks. Pembrolizumab: Powder solution for infusion
Pembrolizumab Plus Radiotherapy
n=9 participants at risk
If The patient is randomised to this arm they will receive 200mg of pembrolizumab every 3 weeks in combination with a radiotherapy dosage of 24Gy in 3 fractions to be given over 3 consecutive days (only). Pembrolizumab: Powder solution for infusion Radiotherapy: 24Gy
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
General disorders
Fatigue
75.0%
6/8 • Number of events 17 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
55.6%
5/9 • Number of events 14 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Vascular disorders
Hypertension
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Injury, poisoning and procedural complications
Dermatitis radiation
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
44.4%
4/9 • Number of events 16 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Blood and lymphatic system disorders
Anaemia
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
General disorders
Edema limbs
25.0%
2/8 • Number of events 14 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 7 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Rash maculo-papular
12.5%
1/8 • Number of events 5 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 15 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Erythema multiforme
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Infections and infestations
Mucosal infection
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 6 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Constipation
12.5%
1/8 • Number of events 4 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Metabolism and nutrition disorders
Hypophosphatemia
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Endocrine disorders
Hypothyroidism
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Diarrhea
25.0%
2/8 • Number of events 11 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Abdominal pain
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 2 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Nervous system disorders
Paresthesia
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 4 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Renal and urinary disorders
Urinary incontinence
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Fecal incontinence
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Colitis
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 4 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Psychiatric disorders
Depression
12.5%
1/8 • Number of events 2 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Bloating
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Nausea
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Vascular disorders
Hot flashes
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Vascular disorders
Lymphedema
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Pain of skin
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Proctitis
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Nervous system disorders
Peripheral motor neuropathy
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Dry skin
12.5%
1/8 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 2 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
General disorders
Pain
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 16 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Infections and infestations
Skin infection
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
22.2%
2/9 • Number of events 6 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Nervous system disorders
Headache
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 4 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Metabolism and nutrition disorders
Anorexia
12.5%
1/8 • Number of events 4 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Investigations
Weight gain
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
General disorders
Flu like symptoms
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Endocrine disorders
Hyperthyroidism
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 2 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Gastroesophageal reflux disease
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Immune system disorders
Allergic reaction
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Rash acneiform
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 7 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Infections and infestations
Rash pustular
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Investigations
Alanine aminotransferase increased
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Investigations
GGT increased
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Investigations
Aspartate aminotransferase increased
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Investigations
Other - elevated LDH
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Eye disorders
Other - conjunctival haemorrhage
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Other - rash
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Skin and subcutaneous tissue disorders
Other - groin lump
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Eye disorders
Other - pruritus
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
General disorders
Other - increased sciatic pain
0.00%
0/8 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
11.1%
1/9 • Number of events 6 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Investigations
Weight loss
25.0%
2/8 • Number of events 7 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Dry mouth
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Infections and infestations
Urinary tract infection
12.5%
1/8 • Number of events 5 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Cardiac disorders
Heart failure
12.5%
1/8 • Number of events 13 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Psychiatric disorders
Insomnia
25.0%
2/8 • Number of events 6 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Renal and urinary disorders
Urinary retention
12.5%
1/8 • Number of events 6 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Gastrointestinal disorders
Vomiting
12.5%
1/8 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Cardiac disorders
Atrial fibrillation
12.5%
1/8 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Respiratory, thoracic and mediastinal disorders
Pneumonitis
12.5%
1/8 • Number of events 2 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Nervous system disorders
Lethargy
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Infections and infestations
Lung infection
12.5%
1/8 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Musculoskeletal and connective tissue disorders
Buttock pain
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Eye disorders
Dry eye
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Metabolism and nutrition disorders
Hypomagnesemia
12.5%
1/8 • Number of events 2 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Respiratory, thoracic and mediastinal disorders
Dyspnea
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Metabolism and nutrition disorders
Hypermagnesemia
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Cardiac disorders
Left ventricular systolic dysfunction
12.5%
1/8 • Number of events 3 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Musculoskeletal and connective tissue disorders
Pain in extremity
12.5%
1/8 • Number of events 2 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Metabolism and nutrition disorders
Hyperglycemia
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Metabolism and nutrition disorders
Hypoglycemia
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Renal and urinary disorders
Other - urinary hesitancy
12.5%
1/8 • Number of events 7 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other - fungating mass left chess wall, scalp and neck
12.5%
1/8 • Number of events 2 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
Endocrine disorders
Other - thyroid imbalance
12.5%
1/8 • Number of events 1 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).
0.00%
0/9 • AEs were graded and recorded entry into the trial, at cycle 1 day 1 of pembrolizumab, at start of each 21-day cycle, until final safety follow up at 30 days after last dose (up to 12 months). Patients receiving radiotherapy in combination with pembrolizumab, had radiotherapy toxicities graded recorded weekly during radiotherapy (cycle 1 & 2), then 3-weekly (cycles 3+) as well as late toxicities 3-monthly until 24 months. All cause mortality recorded until death or end of trial (36 months).

Additional Information

PERM Senior Trial Manager

The Royal Marsden NHS Foundation Trust

Phone: (+44) 02089156666

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place