Trial Outcomes & Findings for Pembrolizumab in HNSCC With Residual Disease After Radiation (NCT NCT02892201)
NCT ID: NCT02892201
Last Updated: 2025-07-29
Results Overview
To determine the overall response rate based on RECIST 1.1 to pembrolizumab for patients with residual disease following radiation with or without systemic therapy for squamous cell carcinoma of the head and neck. For lesions considered too small for measurement by RECIST 1.1 a modified response criteria will be used. RECIST categories used for the target lesion are complete response (CR), partial response (PR), stable disease (NR/SD), and progressive disease (PD). Upon entry of results, the time frame was corrected to 12 weeks (see attached protocol).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-07-29
Participant Flow
Study was activated for enrollment on 9/08/2016 and was closed for low enrollment on 03/31/2020. Enrollment done in a medical Clinic.
Participant milestones
| Measure |
All Subjects
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab in HNSCC With Residual Disease After Radiation
Baseline characteristics by cohort
| Measure |
All Subjects
n=9 Participants
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksTo determine the overall response rate based on RECIST 1.1 to pembrolizumab for patients with residual disease following radiation with or without systemic therapy for squamous cell carcinoma of the head and neck. For lesions considered too small for measurement by RECIST 1.1 a modified response criteria will be used. RECIST categories used for the target lesion are complete response (CR), partial response (PR), stable disease (NR/SD), and progressive disease (PD). Upon entry of results, the time frame was corrected to 12 weeks (see attached protocol).
Outcome measures
| Measure |
All Subjects
n=9 Participants
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Overall Response Rate
complete response (CR)
|
1 Participants
|
|
Overall Response Rate
partial response (PR)
|
1 Participants
|
|
Overall Response Rate
stable disease (SD)
|
0 Participants
|
|
Overall Response Rate
progressive disease (PD)
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 4 weeksPopulation: 6 total participants had evaluable data at baseline, 2 had evaluable data at the 4 week follow up and 1 person withdrew consent at follow up.
To determine changes in PD-L1 expression following irradiation, the Modified Proportion Score or MPS was used. MPS is a scale of 0-100 and it represents the overall % positive cells expressing PD-L1 where the greater the score, the more likely there will be a response to treatment. This outcome was updated/corrected at the time of results entry.
Outcome measures
| Measure |
All Subjects
n=6 Participants
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Change in PD-L1 Expression
Baseline
|
25.5 score on a scale
Interval 0.0 to 90.0
|
|
Change in PD-L1 Expression
Week 4
|
7.5 score on a scale
Interval 0.0 to 15.0
|
|
Change in PD-L1 Expression
Baseline to Week 4 Change on Matched Cases
|
17.5 score on a scale
Interval 0.0 to 35.0
|
SECONDARY outcome
Timeframe: Up to 168 weeksTo evaluate median progression free survival in days. Upon entry of results, the time frame was corrected to the full amount of time that participants were followed up with.
Outcome measures
| Measure |
All Subjects
n=9 Participants
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Median Progression Free Survival
|
74 days
Interval 14.0 to 1902.0
|
SECONDARY outcome
Timeframe: 168 weeksPopulation: 1 person withdrew consent for long term follow up.
To evaluate overall survival. Overall survival is presented as a count of those deceased and living at the end of the follow up period.
Outcome measures
| Measure |
All Subjects
n=8 Participants
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Overall Survival
Confirmed Deceased
|
5 Participants
|
|
Overall Survival
Confirmed Living
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 168 weeksPopulation: 1 person withdrew consent for long term follow up.
To evaluate overall survival, the median overall survival time is presented in days through the study and follow up periods.This outcome was reported at the time of results entry to compliment the count of participants in the Overall Survival outcome.
Outcome measures
| Measure |
All Subjects
n=8 Participants
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Median Overall Survival
|
505 days
Interval 243.0 to 1905.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksTo determine the number of participants receiving immunotherapy following radiation with or without systemic therapy. This outcome was updated/corrected at the time of results entry.
Outcome measures
| Measure |
All Subjects
n=9 Participants
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Count of Participants With Immune Related Adverse Events
Experienced immune related adverse event
|
4 Participants
|
|
Count of Participants With Immune Related Adverse Events
Did not experience an immune related adverse event
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 168 WeeksPopulation: 1 participant withdrew consent for follow up.
Presented are a count of those that experienced distant metastases during the study period and follow up period. This outcome was updated/corrected when results were entered.
Outcome measures
| Measure |
All Subjects
n=8 Participants
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Count of Those With Distant Metastases
Distant Metastases: YES
|
1 Participants
|
|
Count of Those With Distant Metastases
Distant Metastases: NO
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 168 weeksTo determine the overall response rate based on RECIST 1.1 to pembrolizumab for patients with residual disease following radiation with or without systemic therapy for squamous cell carcinoma of the head and neck. For lesions considered too small for measurement by RECIST 1.1 a modified response criteria will be used. RECIST categories used for the target lesion are complete response (CR), partial response (PR), stable disease (NR/SD), and progressive disease (PD). This outcome was originally incorrectly listed as a secondary outcome.
Outcome measures
Outcome data not reported
Adverse Events
All Subjects
Serious events: 6 serious events
Other events: 8 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
All Subjects
n=9 participants at risk
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Cardiac disorders
Myocardial infarction
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Gastrointestinal disorders
Oral hemorrhage
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Infections and infestations
Upper respiratory infection
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Renal and urinary disorders
Hematuria
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal hemorrhage
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
General disorders
Hypotension
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
Other adverse events
| Measure |
All Subjects
n=9 participants at risk
For patients with squamous cell carcinoma of the head and neck who have residual disease following definitive therapy with radiation
Pembrolizumab will be given at a constant dose of 200 mg every three weeks, for four cycles. Patients with resectable disease can then go on to surgery, and patients with unresectable disease can continue on pembrolizumab until progression or for up to 1 year.
Pembrolizumab: a constant dose of 200 mg every three weeks, for four cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
11.1%
1/9 • Number of events 2 • Up to 168 weeks
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Endocrine disorders
Hypothyroidism
|
22.2%
2/9 • Number of events 2 • Up to 168 weeks
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
22.2%
2/9 • Number of events 2 • Up to 168 weeks
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • Up to 168 weeks
|
|
Gastrointestinal disorders
Periodontal disease
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
General disorders
Fatigue
|
33.3%
3/9 • Number of events 4 • Up to 168 weeks
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
44.4%
4/9 • Number of events 16 • Up to 168 weeks
|
|
General disorders
Localized edema
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
General disorders
Neck edema
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Infections and infestations
Infections and infestations - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Injury, poisoning and procedural complications
Bruising
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Investigations
Alkaline phosphatase increased
|
22.2%
2/9 • Number of events 4 • Up to 168 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Investigations
Creatinine increased
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Investigations
Lymphocyte count decreased
|
22.2%
2/9 • Number of events 3 • Up to 168 weeks
|
|
Investigations
Platelet count decreased
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Investigations
Weight loss
|
33.3%
3/9 • Number of events 5 • Up to 168 weeks
|
|
Investigations
White blood cell decreased
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
2/9 • Number of events 4 • Up to 168 weeks
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • Number of events 2 • Up to 168 weeks
|
|
Renal and urinary disorders
Urinary frequency
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
11.1%
1/9 • Number of events 2 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
11.1%
1/9 • Number of events 1 • Up to 168 weeks
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
11.1%
1/9 • Number of events 2 • Up to 168 weeks
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Number of events 7 • Up to 168 weeks
|
|
Vascular disorders
Hypotension
|
22.2%
2/9 • Number of events 2 • Up to 168 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place