Trial Outcomes & Findings for Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in SCCHN (NCT NCT03085719)
NCT ID: NCT03085719
Last Updated: 2025-02-25
Results Overview
The primary endpoint of this study is progression-free survival (PFS) rate at 3 months. Patients are considered progression-free at 3 months if progression is not observed at the 3-month disease assessment. PFS is defined as the time from registration to disease progression per RECIST or death, whichever occurred first. Progressive Disease is defined as at least a 20% increase in the sum of diameters of target lesions, which must also demonstrate an absolute increase of at least 5 mm (with reference to the smallest sum on study). The appearance of one or more new lesions is also considered progressions (RECIST guidelines version 1.1).
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
1 year
Results posted on
2025-02-25
Participant Flow
Participant milestones
| Measure |
High Dose Radiation + Pembrolizumab
* High dose radiation will be given in 3 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
High Dose + Low Dose Radiation + Pembrolizumab
* High Dose radiation will be given in 3 fractions
* Low Dose Radiation will be given in 2 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting PD-1 Therapy Resistance With Focused High or High and Low Dose Radiation in SCCHN
Baseline characteristics by cohort
| Measure |
High Dose Radiation + Pembrolizumab
n=6 Participants
* High dose radiation will be given in 3 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
High Dose + Low Dose Radiation + Pembrolizumab
n=12 Participants
* High Dose radiation will be given in 3 fractions
* Low Dose Radiation will be given in 2 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
M Stage
M1
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
M Stage
Missing
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Disease Stage
Stage III
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Age, Continuous
|
59 years
n=99 Participants
|
67 years
n=107 Participants
|
65.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
ECOG PS
0
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
ECOG PS
1
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
ECOG PS
2
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Smoking Status
Current Smoker
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Smoking Status
Former Smoker
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Smoking Status
Never Smoked
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
T Stage
T1
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
T Stage
T2
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
T Stage
T3
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
T Stage
T4
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
T Stage
TX
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
T Stage
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
N Stage
N0
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
N Stage
N1
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
N Stage
N2
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
N Stage
N3
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
N Stage
NX
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
N Stage
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
M Stage
M0
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Disease Stage
Stage IV
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Disease Stage
Missing
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Disease Site
Oropharynx
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Disease Site
Hypopharynx
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Disease Site
Oral Cavity
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Disease Site
Larynx
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Disease Site
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Pathology
Squamous Cell Carcinoma
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Pathology
Other
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
HIV Status
Negative
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
HIV Status
Unknown
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
HPV Status
Negative
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
HPV Status
Positive
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
HPV Status
Unknown
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Prior Treatment
Chemotherapy
|
5 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Prior Treatment
Surgery
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Prior Treatment
Radiation Therapy
|
6 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Prior IO Therapy Type
Nivolumab
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Prior IO Therapy Type
Nivolumab/Lirilumab
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Prior IO Therapy Type
Pembrolizumab
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Prior IO Therapy Type
Other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed under Primary Outcome were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
The primary endpoint of this study is progression-free survival (PFS) rate at 3 months. Patients are considered progression-free at 3 months if progression is not observed at the 3-month disease assessment. PFS is defined as the time from registration to disease progression per RECIST or death, whichever occurred first. Progressive Disease is defined as at least a 20% increase in the sum of diameters of target lesions, which must also demonstrate an absolute increase of at least 5 mm (with reference to the smallest sum on study). The appearance of one or more new lesions is also considered progressions (RECIST guidelines version 1.1).
Outcome measures
| Measure |
High Dose Radiation + Pembrolizumab
n=6 Participants
* High dose radiation will be given in 3 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
High Dose + Low Dose Radiation + Pembrolizumab
n=12 Participants
* High Dose radiation will be given in 3 fractions
* Low Dose Radiation will be given in 2 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
|---|---|---|
|
Progression-Free Surival
|
1 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearOutcome measures
Outcome data not reported
Adverse Events
High Dose Radiation + Pembrolizumab
Serious events: 3 serious events
Other events: 4 other events
Deaths: 6 deaths
High Dose + Low Dose Radiation + Pembrolizumab
Serious events: 7 serious events
Other events: 12 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
High Dose Radiation + Pembrolizumab
n=6 participants at risk
* High dose radiation will be given in 3 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
High Dose + Low Dose Radiation + Pembrolizumab
n=12 participants at risk
* High Dose radiation will be given in 3 fractions
* Low Dose Radiation will be given in 2 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Oral/nasal bleeding
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Esophageal Hemorrhage
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Injury, poisoning and procedural complications
Intraoperative skin injury
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Injury, poisoning and procedural complications
Tracheostomy site bleeding
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
General disorders
Death NOS
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Eye disorders
Eye infection
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
Other adverse events
| Measure |
High Dose Radiation + Pembrolizumab
n=6 participants at risk
* High dose radiation will be given in 3 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
High Dose + Low Dose Radiation + Pembrolizumab
n=12 participants at risk
* High Dose radiation will be given in 3 fractions
* Low Dose Radiation will be given in 2 fractions
* Pembrolizumab administered intravenously on day one of each cycle.
Pembrolizumab: Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
Radiation: Radiation is used to shrink the cancer
|
|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
33.3%
4/12 • Number of events 4 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Dry mouth
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
25.0%
3/12 • Number of events 3 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
50.0%
6/12 • Number of events 6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Ear and labyrinth disorders
Hearing impaired
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
25.0%
3/12 • Number of events 3 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Injury, poisoning and procedural complications
Tumor site bleeding
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Mucositis oral
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Oral hemorrhage
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
General disorders
Pain
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Eye disorders
Watering eyes
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
General disorders
Chills
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Investigations
Creatinine Increased
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
General disorders
Edema Face
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
General disorders
Edema Limbs
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
33.3%
4/12 • Number of events 5 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Vascular disorders
Lymphedema
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
16.7%
2/12 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Investigations
White blood cell decreased
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
8.3%
1/12 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Eye disorders
Eye disorders - Other, specify
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
General disorders
Facial Pain
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
2/6 • Number of events 2 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
General disorders
Neck edema
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
|
Cardiac disorders
Ventricular tachycardia
|
16.7%
1/6 • Number of events 1 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
0.00%
0/12 • Adverse events were evaluated from baseline through the end of treatment (30 days after the last study intervention), for a maximum total duration of 15 months. This time period varied depending on how many total treatment cycles each patient was given.
All toxicities that were definitely, probably, possibly, or not related to protocol treatment were included. The groups of 'High Dose Radiation + Pembrolizumab' and 'High Dose + Low Dose Radiation + Pembrolizumab' listed in Adverse Events were the predefined groups in the study protocol; this was not a dose escalation study for pembrolizumab.
|
Additional Information
Jonathan Schoenfeld, MD, MPH
Dana-Farber Cancer Institute
Phone: 617-582-8731
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place