Trial Outcomes & Findings for Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck (NCT NCT02289209)

Last Updated: 2025-03-06

Results Overview

Number of months from the date of initiation of treatment to the date of progression of disease or death (whichever occurs first). Progressive disease, per RECIST 1.1, is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

Up to 36 months (after starting reirradiation and MK-3475)

Results posted on

2025-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Reirradiation + MK-3475 Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Overall Study STARTED	48
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reirradiation With Pembrolizumab in Locoregional Inoperable Recurrence or Second Primary Squamous Cell CA of the Head and Neck

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reirradiation + MK-3475 n=48 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Age, Continuous	64.17 years STANDARD_DEVIATION 8.57 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 months (after starting reirradiation and MK-3475)

Population: All treated patients who were radiologically evaluable and experienced disease progression.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=48 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Progression Free Survival	7.9 months Interval 4.3 to 10.2

SECONDARY outcome

Timeframe: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)

Population: All treated patients who achieved radiologic response.

The percentage of the patients who have either Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, or, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The patient's best overall response rate defined as the best response recorded from the start of the treatment until disease progression will be recorded, per RECIST 1.1.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=23 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Best Overall Response Rate (ORR)	56.1 percentage of patients Interval 39.7 to 71.95

SECONDARY outcome

Timeframe: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)

Population: All treated patients who achieved radiologic response or stable disease.

The percentage of patients that have achieved a complete response, partial response, and stable disease as defined by RECIST 1.1. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, or Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=32 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Clinical Benefit Rate (CBR)	78.0 percentage of participants Interval 62.4 to 89.4

SECONDARY outcome

Timeframe: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)

Population: Zero patients with results.

Number of months from initiation of treatment to progression of disease within the radiation field.Progressive disease, per RECIST 1.1, is defined as: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=48 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Time to in Field Disease Progression	13.1 months Interval 9.1 to Upper bound of 95% CI not reached due to low number of events.

SECONDARY outcome

Timeframe: Up to 36 months (after initiation of treatment with reirradiation and MK-3475)

Population: All patients enrolled in the trial.

Number of months from first treatment until death. Patients who are alive will be censored at the last date of patient contact.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=48 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Overall Survival (OS)	13.1 months Interval 9.4 to 21.5

SECONDARY outcome

Timeframe: At Baseline

Population: Treated patients who completed Quality of Life evaluations.

Patient reported outcomes will be measured using EORTC QLQ-C30 questionnaires. This tool contains 30 items. It measures 5 functional dimensions (physical, role, cognitive, social, emotional), 6 single items (appetite loss, constipation, dyspnea, financial impact, sleep disturbance, diarrhea), 3 symptom items (fatigue, pain, nausea/vomiting) and a global health and quality of life scale. Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=48 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-C30 - Baseline Global Health Status	58.33 score on a scale Standard Deviation 24.06
Quality of Life Using EORTC QLQ-C30 - Baseline Physical Functioning	77.69 score on a scale Standard Deviation 24.55
Quality of Life Using EORTC QLQ-C30 - Baseline Role Functioning	66.33 score on a scale Standard Deviation 30.90
Quality of Life Using EORTC QLQ-C30 - Baseline Emotional Functioning	71.53 score on a scale Standard Deviation 26.06
Quality of Life Using EORTC QLQ-C30 - Baseline Cognitive Functioning	78.47 score on a scale Standard Deviation 25.02
Quality of Life Using EORTC QLQ-C30 - Baseline Social Functioning	66.67 score on a scale Standard Deviation 32.43
Quality of Life Using EORTC QLQ-C30 - Baseline Fatigue	36.34 score on a scale Standard Deviation 29.15
Quality of Life Using EORTC QLQ-C30 - Baseline Nausea and Vomiting	8.50 score on a scale Standard Deviation 16.36
Quality of Life Using EORTC QLQ-C30 - Baseline Pain	44.44 score on a scale Standard Deviation 32.86
Quality of Life Using EORTC QLQ-C30 - Baseline Dyspnea	13.61 score on a scale Standard Deviation 20.32
Quality of Life Using EORTC QLQ-C30 - Baseline Insomnia	34.69 score on a scale Standard Deviation 35.33
Quality of Life Using EORTC QLQ-C30 - Baseline Appetite Loss	23.61 score on a scale Standard Deviation 30.72
Quality of Life Using EORTC QLQ-C30 - Baseline Constipation	25.85 score on a scale Standard Deviation 32.82
Quality of Life Using EORTC QLQ-C30 - Baseline Diarrhea	10.20 score on a scale Standard Deviation 23.77
Quality of Life Using EORTC QLQ-C30 - Baseline Financial concerns	21.09 score on a scale Standard Deviation 30.95

SECONDARY outcome

Timeframe: At Cycle 3 (Week 6)

Population: Treated patients who completed Quality of Life evaluations.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=41 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Global Health Status	59.96 score on a scale Standard Deviation 18.93
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Physical Functioning	78.37 score on a scale Standard Deviation 21.38
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Role Functioning	63.01 score on a scale Standard Deviation 32.81
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Emotional Functioning	81.25 score on a scale Standard Deviation 23.93
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Cognitive Functioning	76.83 score on a scale Standard Deviation 23.53
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Social Functioning	73.17 score on a scale Standard Deviation 29.32
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Fatigue	41.46 score on a scale Standard Deviation 28.33
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Nausea and Vomiting	10.57 score on a scale Standard Deviation 13.31
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Pain	41.67 score on a scale Standard Deviation 29.96
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Dyspnea	16.26 score on a scale Standard Deviation 22.51
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Insomnia	29.27 score on a scale Standard Deviation 30.91
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Appetite Loss	31.67 score on a scale Standard Deviation 32.86
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Constipation	19.51 score on a scale Standard Deviation 24.69
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Diarrhea	5.69 score on a scale Standard Deviation 14.72
Quality of Life Using EORTC QLQ-C30 - Cycle 3 Financial concerns	15.45 score on a scale Standard Deviation 23.68

SECONDARY outcome

Timeframe: At Cycle 9 (Week 26)

Population: Treated patients who completed Quality of Life evaluations.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=25 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Global Health Status	61.00 score on a scale Standard Deviation 24.26
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Physical Functioning	74.93 score on a scale Standard Deviation 30.57
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Role Functioning	64.00 score on a scale Standard Deviation 33.22
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Emotional Functioning	77.78 score on a scale Standard Deviation 24.16
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Cognitive Functioning	75.33 score on a scale Standard Deviation 33.03
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Social Functioning	71.33 score on a scale Standard Deviation 30.63
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Fatigue	40.00 score on a scale Standard Deviation 31.75
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Nausea and Vomiting	8.67 score on a scale Standard Deviation 21.58
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Pain	40.00 score on a scale Standard Deviation 37.27
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Dyspnea	9.33 score on a scale Standard Deviation 22.61
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Insomnia	29.33 score on a scale Standard Deviation 35.12
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Appetite Loss	19.44 score on a scale Standard Deviation 32.48
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Constipation	20.00 score on a scale Standard Deviation 30.43
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Diarrhea	4.00 score on a scale Standard Deviation 11.06
Quality of Life Using EORTC QLQ-C30 - Cycle 9 Financial concerns	17.33 score on a scale Standard Deviation 30.61

SECONDARY outcome

Timeframe: At 12 months

Population: Treated patients who completed Quality of Life evaluations.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=10 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-C30 - 12 Months Global Health Status	72.50 score on a scale Standard Deviation 16.69
Quality of Life Using EORTC QLQ-C30 - 12 Months Physical Functioning	84.67 score on a scale Standard Deviation 16.94
Quality of Life Using EORTC QLQ-C30 - 12 Months Role Functioning	85.00 score on a scale Standard Deviation 16.57
Quality of Life Using EORTC QLQ-C30 - 12 Months Emotional Functioning	85.00 score on a scale Standard Deviation 16.57
Quality of Life Using EORTC QLQ-C30 - 12 Months Cognitive Functioning	91.67 score on a scale Standard Deviation 14.16
Quality of Life Using EORTC QLQ-C30 - 12 Months Social Functioning	86.67 score on a scale Standard Deviation 23.31
Quality of Life Using EORTC QLQ-C30 - 12 Months Fatigue	14.44 score on a scale Standard Deviation 17.41
Quality of Life Using EORTC QLQ-C30 - 12 Months Nausea and Vomiting	0.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-C30 - 12 Months Pain	26.67 score on a scale Standard Deviation 22.50
Quality of Life Using EORTC QLQ-C30 - 12 Months Dyspnea	6.67 score on a scale Standard Deviation 21.08
Quality of Life Using EORTC QLQ-C30 - 12 Months Insomnia	6.67 score on a scale Standard Deviation 21.08
Quality of Life Using EORTC QLQ-C30 - 12 Months Appetite Loss	20.00 score on a scale Standard Deviation 23.31
Quality of Life Using EORTC QLQ-C30 - 12 Months Constipation	3.33 score on a scale Standard Deviation 10.54
Quality of Life Using EORTC QLQ-C30 - 12 Months Diarrhea	3.33 score on a scale Standard Deviation 10.54
Quality of Life Using EORTC QLQ-C30 - 12 Months Financial concerns	16.67 score on a scale Standard Deviation 28.33

SECONDARY outcome

Timeframe: At 36 months

Population: Treated patients who completed Quality of Life evaluations.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=3 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-C30 - 36 Months Global Health Status	75.00 score on a scale Standard Deviation 22.05
Quality of Life Using EORTC QLQ-C30 - 36 Months Physical Functioning	95.56 score on a scale Standard Deviation 3.85
Quality of Life Using EORTC QLQ-C30 - 36 Months Role Functioning	88.89 score on a scale Standard Deviation 19.25
Quality of Life Using EORTC QLQ-C30 - 36 Months Emotional Functioning	88.89 score on a scale Standard Deviation 12.73
Quality of Life Using EORTC QLQ-C30 - 36 Months Cognitive Functioning	94.44 score on a scale Standard Deviation 9.62
Quality of Life Using EORTC QLQ-C30 - 36 Months Social Functioning	66.67 score on a scale Standard Deviation 57.74
Quality of Life Using EORTC QLQ-C30 - 36 Months Fatigue	11.11 score on a scale Standard Deviation 19.25
Quality of Life Using EORTC QLQ-C30 - 36 Months Nausea and Vomiting	0.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-C30 - 36 Months Pain	5.56 score on a scale Standard Deviation 9.62
Quality of Life Using EORTC QLQ-C30 - 36 Months Dyspnea	0.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-C30 - 36 Months Insomnia	11.11 score on a scale Standard Deviation 19.25
Quality of Life Using EORTC QLQ-C30 - 36 Months Appetite Loss	11.11 score on a scale Standard Deviation 19.25
Quality of Life Using EORTC QLQ-C30 - 36 Months Constipation	11.11 score on a scale Standard Deviation 19.25
Quality of Life Using EORTC QLQ-C30 - 36 Months Diarrhea	0.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-C30 - 36 Months Financial concerns	33.33 score on a scale Standard Deviation 57.74

SECONDARY outcome

Timeframe: At Baseline

Population: Treated patients who completed Quality of Life evaluations.

Patient reported outcomes will be measured using the EORTC QLQ-H\&N35, a 35-item questionnaire that assesses symptoms encountered specifically by patients with head and neck cancer. This measure generates 7 multiple-item scales (Pain, Swallowing, Senses, Speech, Social eating, Social contact, and Sexuality), in addition to 11 single items (eg, Opening mouth, Sticky saliva, Dry mouth, etc). Scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=48 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Pain	38.89 score on a scale Standard Deviation 33.21
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Swallowing Problems	40.08 score on a scale Standard Deviation 35.13
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Sensory Problems	32.58 score on a scale Standard Deviation 32.34
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Speech Problems	42.68 score on a scale Standard Deviation 31.69
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Trouble with Social Eating	39.07 score on a scale Standard Deviation 32.46
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Trouble with Social Contact	16.53 score on a scale Standard Deviation 20.07
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Less Sexuality	25.19 score on a scale Standard Deviation 37.54
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Teeth Problems	21.01 score on a scale Standard Deviation 36.08
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Mouth Opening Problems	48.61 score on a scale Standard Deviation 39.48
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Dry Mouth	46.53 score on a scale Standard Deviation 38.12
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Sticky Saliva	45.14 score on a scale Standard Deviation 42.66
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Coughing	35.46 score on a scale Standard Deviation 34.34
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Feeling Ill	27.08 score on a scale Standard Deviation 34.14
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Painkiller Use	74.47 score on a scale Standard Deviation 44.08
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Nutritional Supplement Use	62.50 score on a scale Standard Deviation 48.92
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Feeding Tube Use	37.50 score on a scale Standard Deviation 48.92
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Weight Loss	31.25 score on a scale Standard Deviation 46.84
Quality of Life Using EORTC QLQ-H&N 35 - Baseline Weight Gain	20.83 score on a scale Standard Deviation 41.04

SECONDARY outcome

Timeframe: At Cycle 3 (Week 6)

Population: Treated patients who completed Quality of Life evaluations.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=41 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Pain	41.87 score on a scale Standard Deviation 32.09
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Swallowing Problems	45.83 score on a scale Standard Deviation 34.47
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Sensory Problems	43.24 score on a scale Standard Deviation 29.52
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Speech Problems	43.54 score on a scale Standard Deviation 27.89
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Trouble with Social Eating	47.97 score on a scale Standard Deviation 32.89
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Trouble with Social Contact	16.75 score on a scale Standard Deviation 23.79
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Less Sexuality	30.56 score on a scale Standard Deviation 39.14
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Teeth Problems	16.24 score on a scale Standard Deviation 29.49
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Mouth Opening Problems	54.47 score on a scale Standard Deviation 37.83
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Dry Mouth	51.22 score on a scale Standard Deviation 35.82
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Sticky Saliva	62.50 score on a scale Standard Deviation 35.56
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Coughing	37.40 score on a scale Standard Deviation 30.00
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Feeling Ill	21.95 score on a scale Standard Deviation 29.45
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Painkiller Use	82.93 score on a scale Standard Deviation 38.09
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Nutritional Supplement Use	56.10 score on a scale Standard Deviation 50.24
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Feeding Tube Use	58.54 score on a scale Standard Deviation 49.88
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Weight Loss	50.00 score on a scale Standard Deviation 50.64
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 3 Weight Gain	22.50 score on a scale Standard Deviation 42.29

SECONDARY outcome

Timeframe: At Cycle 9 (Week 26)

Population: Treated patients who completed Quality of Life evaluations.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=25 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Pain	29.33 score on a scale Standard Deviation 25.13
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Swallowing Problems	31.75 score on a scale Standard Deviation 33.61
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Sensory Problems	32.54 score on a scale Standard Deviation 34.35
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Speech Problems	40.10 score on a scale Standard Deviation 29.35
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Trouble with Social Eating	32.25 score on a scale Standard Deviation 29.97
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Trouble with Social Contact	20.27 score on a scale Standard Deviation 26.28
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Less Sexuality	32.54 score on a scale Standard Deviation 40.99
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Teeth Problems	27.54 score on a scale Standard Deviation 39.76
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Mouth Opening Problems	48.00 score on a scale Standard Deviation 43.12
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Dry Mouth	52.00 score on a scale Standard Deviation 33.44
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Sticky Saliva	52.00 score on a scale Standard Deviation 36.11
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Coughing	31.94 score on a scale Standard Deviation 26.88
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Feeling Ill	16.00 score on a scale Standard Deviation 29.06
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Painkiller Use	68.00 score on a scale Standard Deviation 47.61
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Nutritional Supplement Use	62.50 score on a scale Standard Deviation 49.45
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Feeding Tube Use	36.00 score on a scale Standard Deviation 48.99
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Weight Loss	33.33 score on a scale Standard Deviation 48.15
Quality of Life Using EORTC QLQ-H&N 35 - Cycle 9 Weight Gain	16.00 score on a scale Standard Deviation 37.42

SECONDARY outcome

Timeframe: At 12 months

Population: Treated patients who completed Quality of Life evaluations.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=10 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Pain	10.00 score on a scale Standard Deviation 12.30
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Swallowing Problems	52.50 score on a scale Standard Deviation 46.98
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Sensory Problems	30.00 score on a scale Standard Deviation 29.19
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Speech Problems	51.11 score on a scale Standard Deviation 28.30
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Trouble with Social Eating	54.17 score on a scale Standard Deviation 41.99
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Trouble with Social Contact	11.33 score on a scale Standard Deviation 16.64
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Less Sexuality	33.33 score on a scale Standard Deviation 47.14
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Teeth Problems	33.33 score on a scale Standard Deviation 38.49
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Mouth Opening Problems	74.07 score on a scale Standard Deviation 36.43
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Dry Mouth	66.67 score on a scale Standard Deviation 35.14
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Sticky Saliva	46.67 score on a scale Standard Deviation 39.13
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Coughing	26.67 score on a scale Standard Deviation 34.43
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Feeling Ill	10.00 score on a scale Standard Deviation 22.50
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Painkiller Use	60.00 score on a scale Standard Deviation 51.64
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Nutritional Supplement Use	80.00 score on a scale Standard Deviation 42.16
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Feeding Tube Use	50.00 score on a scale Standard Deviation 52.70
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Weight Loss	20.00 score on a scale Standard Deviation 42.16
Quality of Life Using EORTC QLQ-H&N 35 - 12 Months Weight Gain	10.00 score on a scale Standard Deviation 31.62

SECONDARY outcome

Timeframe: At 36 months

Population: Treated patients who completed Quality of Life evaluations.

Outcome measures

Outcome measures
Measure	Reirradiation + MK-3475 n=3 Participants Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Pain	0.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Swallowing Problems	66.67 score on a scale Standard Deviation 11.79
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Sensory Problems	0.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Speech Problems	59.26 score on a scale Standard Deviation 16.97
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Trouble with Social Eating	72.22 score on a scale Standard Deviation 34.69
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Trouble with Social Contact	33.33 score on a scale Standard Deviation 57.74
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Less Sexuality	33.33 score on a scale Standard Deviation 57.74
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Teeth Problems	22.22 score on a scale Standard Deviation 19.25
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Mouth Opening Problems	50.00 score on a scale Standard Deviation 23.57
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Dry Mouth	33.33 score on a scale Standard Deviation 33.33
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Sticky Saliva	44.44 score on a scale Standard Deviation 50.92
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Coughing	11.11 score on a scale Standard Deviation 19.25
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Feeling Ill	0.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Painkiller Use	33.33 score on a scale Standard Deviation 57.74
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Nutritional Supplement Use	100.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Feeding Tube Use	100.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Weight Loss	0.00 score on a scale Standard Deviation 0.00
Quality of Life Using EORTC QLQ-H&N 35 - 36 Months Weight Gain	0.00 score on a scale Standard Deviation 0.00

Adverse Events

Reirradiation + MK-3475

Serious events: 27 serious events

Other events: 46 other events

Deaths: 37 deaths

Serious adverse events

Serious adverse events
Measure	Reirradiation + MK-3475 n=48 participants at risk Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Blood and lymphatic system disorders Anemia	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Cardiac disorders Cardiac arrest	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Diarrhea	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Dysphagia	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Lower gastrointestinal hemorrhage	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Nausea	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Oral hemorrhage	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Pancreatitis	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Vomiting	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Death NOS	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Fatigue	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Fever	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Other, specify	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Lung infection	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Skin infection	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Stoma site infection	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Urinary tract infection	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Injury, poisoning and procedural complications Injury, poisoning and procedural complications_Fall	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Blood bilirubin increased	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Creatinine increased	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Weight loss	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Anorexia	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Dehydration	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hyponatremia	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Generalized muscle weakness	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Depressed level of consciousness	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Somnolence	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Syncope	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Aspiration	16.7% 8/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Dyspnea	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Epistaxis	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months

Other adverse events

Other adverse events
Measure	Reirradiation + MK-3475 n=48 participants at risk Reirradiation 1.2 Gy BID for 5 days a week for 5 weeks with MK-3475 (Keytruda, pembrolizumab) 200mg intravenous every 3 weeks until 3 months post completion of reirradiation. Reirradiation: Reirradiation 1.2 GY BID 5 days a week for 5 weeks. MK-3475: MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
Blood and lymphatic system disorders Anemia	33.3% 16/48 • Adverse event data were collected for a total of 6 years, 7 months
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Blood and lymphatic system disorders Leukocytosis	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Cardiac disorders Cardiac disorders_Palpitations	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Cardiac disorders Cardiac disorders_Sinus bradycardia	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Cardiac disorders Cardiac disorders_Sinus tachycardia	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Ear and labyrinth disorders Other, specify	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Ear and labyrinth disorders Ear pain	14.6% 7/48 • Adverse event data were collected for a total of 6 years, 7 months
Ear and labyrinth disorders Hearing impaired	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Ear and labyrinth disorders Middle ear inflammation	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Ear and labyrinth disorders Tinnitus	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Ear and labyrinth disorders Vertigo	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Endocrine disorders Hyperthyroidism	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Endocrine disorders Hypothyroidism	18.8% 9/48 • Adverse event data were collected for a total of 6 years, 7 months
Eye disorders Blurred vision	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Eye disorders Eye disorders - Other, specify	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Eye disorders Photophobia	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Abdominal pain	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Constipation	45.8% 22/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Diarrhea	20.8% 10/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Dry mouth	37.5% 18/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Dyspepsia	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Dysphagia	33.3% 16/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Gastroesophageal reflux disease	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	12.5% 6/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Mucositis oral	41.7% 20/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Nausea	31.2% 15/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Oral hemorrhage	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Oral pain	27.1% 13/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Salivary duct inflammation	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Stomach pain	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Toothache	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Gastrointestinal disorders Vomiting	12.5% 6/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Chills	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Edema face	16.7% 8/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Edema limbs	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Facial pain	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Fatigue	66.7% 32/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Fever	12.5% 6/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Flu like symptoms	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders General disorders and administration site conditions - Other, specify	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Irritability	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Localized edema	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Malaise	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Non-cardiac chest pain	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
General disorders Pain	18.8% 9/48 • Adverse event data were collected for a total of 6 years, 7 months
Hepatobiliary disorders Bile duct stenosis	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Bladder infection	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Bronchial infection	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Infections and infestations - Other, specify	12.5% 6/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Lung infection	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Mucosal infection	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Otitis media	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Papulopustular rash	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Scrotal infection	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Sinusitis	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Skin infection	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Stoma site infection	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Upper respiratory infection	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Infections and infestations Urinary tract infection	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Injury, poisoning and procedural complications Bruising	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Injury, poisoning and procedural complications Dermatitis radiation	33.3% 16/48 • Adverse event data were collected for a total of 6 years, 7 months
Injury, poisoning and procedural complications Fall	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Alanine aminotransferase increased	16.7% 8/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Alkaline phosphatase increased	14.6% 7/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Aspartate aminotransferase increased	18.8% 9/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Cholesterol high	0.00% 0/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Creatinine increased	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations GGT increased	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Investigations - Other, specify	14.6% 7/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Lymphocyte count decreased	22.9% 11/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Platelet count decreased	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Weight gain	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations Weight loss	43.8% 21/48 • Adverse event data were collected for a total of 6 years, 7 months
Investigations White blood cell decreased	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Anorexia	12.5% 6/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Dehydration	16.7% 8/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hypercalcemia	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hyperglycemia	16.7% 8/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hyperkalemia	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hypermagnesemia	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hypernatremia	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hyperuricemia	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hypoalbuminemia	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hypocalcemia	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hypoglycemia	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hypokalemia	12.5% 6/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hypomagnesemia	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hyponatremia	16.7% 8/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Hypophosphatemia	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Metabolism and nutrition disorders Other, specify	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Back pain	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Chest wall pain	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Fibrosis deep connective tissue	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Myalgia	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Neck pain	27.1% 13/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Neck soft tissue necrosis	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Pain in extremity	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Superficial soft tissue fibrosis	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Musculoskeletal and connective tissue disorders Trismus	22.9% 11/48 • Adverse event data were collected for a total of 6 years, 7 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Aphonia	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Ataxia	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Concentration impairment	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Dizziness	16.7% 8/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Dysarthria	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Dysgeusia	18.8% 9/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Headache	12.5% 6/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Hypoglossal nerve disorder	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Lethargy	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Nervous system disorders - Other, specify	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Neuralgia	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Paresthesia	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Peripheral sensory neuropathy	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Presyncope	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Nervous system disorders Syncope	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Psychiatric disorders Agitation	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Psychiatric disorders Anxiety	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Psychiatric disorders Confusion	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Psychiatric disorders Depression	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Psychiatric disorders Insomnia	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Psychiatric disorders Psychiatric disorders - Other, specify	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Renal and urinary disorders Chronic kidney disease	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Renal and urinary disorders Hematuria	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Renal and urinary disorders Proteinuria	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Renal and urinary disorders Urinary incontinence	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Renal and urinary disorders Urine discoloration	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Aspiration	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Cough	31.2% 15/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Dyspnea	20.8% 10/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Epistaxis	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Hiccups	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Hoarseness	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 3/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Productive cough	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Sore throat	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Respiratory, thoracic and mediastinal disorders Wheezing	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Skin and subcutaneous tissue disorders Alopecia	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Skin and subcutaneous tissue disorders Bullous dermatitis	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Skin and subcutaneous tissue disorders Dry skin	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Skin and subcutaneous tissue disorders Erythema multiforme	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Skin and subcutaneous tissue disorders Pruritus	8.3% 4/48 • Adverse event data were collected for a total of 6 years, 7 months
Skin and subcutaneous tissue disorders Rash maculo-papular	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	12.5% 6/48 • Adverse event data were collected for a total of 6 years, 7 months
Skin and subcutaneous tissue disorders Skin hyperpigmentation	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Skin and subcutaneous tissue disorders Skin ulceration	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Surgical and medical procedures Surgical and medical procedures_Surgical and medical procedures - Other, specify	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Vascular disorders Hot flashes	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months
Vascular disorders Hypertension	14.6% 7/48 • Adverse event data were collected for a total of 6 years, 7 months
Vascular disorders Hypotension	10.4% 5/48 • Adverse event data were collected for a total of 6 years, 7 months
Vascular disorders Lymphedema	4.2% 2/48 • Adverse event data were collected for a total of 6 years, 7 months
Vascular disorders Other, specify	2.1% 1/48 • Adverse event data were collected for a total of 6 years, 7 months

Additional Information

Barbara Stadterman, MPH, CCRP

UPMC Hillman Cancer Center

Phone: 4126475554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place