Trial Outcomes & Findings for The Addition of Pembrolizumab to Postoperative Radiotherapy in Cutaneous Squamous Cell Cancer of the Head and Neck (NCT NCT03057613)
NCT ID: NCT03057613
Last Updated: 2022-06-30
Results Overview
There will be an initial safety run in cohort consisting of an initial safety run in cohort consisting of eight patients to allow for at least six evaluable patients for dose limiting toxicities (DLTs) by the week 20 visit. If a total of 0-2 of the initial six evaluable patients experience DLTs, the safety run in will have been deemed successful and the 29 remaining planned patients will be accrued. DLT for this study is defined as the occurrence of a severe adverse event (AE) that is at least possibly related to pembrolizumab, and occurs from the initiation of treatment thru 30 days after the final administration of the study treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
Up to 20 weeks post treatment
Results posted on
2022-06-30
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + Post Operative Radiotherapy
IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks
Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion
IMRT 60-66Gy: 60-66Gy for 6 weeks
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Addition of Pembrolizumab to Postoperative Radiotherapy in Cutaneous Squamous Cell Cancer of the Head and Neck
Baseline characteristics by cohort
| Measure |
Pembrolizumab + Post Operative Radiotherapy
n=18 Participants
IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks
Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion
IMRT 60-66Gy: 60-66Gy for 6 weeks
|
|---|---|
|
Age, Customized
60-69 years
|
6 Participants
n=93 Participants
|
|
Age, Customized
70-79 years
|
10 Participants
n=93 Participants
|
|
Age, Customized
80-89 years
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 20 weeks post treatmentPopulation: Participants enrolled in study
There will be an initial safety run in cohort consisting of an initial safety run in cohort consisting of eight patients to allow for at least six evaluable patients for dose limiting toxicities (DLTs) by the week 20 visit. If a total of 0-2 of the initial six evaluable patients experience DLTs, the safety run in will have been deemed successful and the 29 remaining planned patients will be accrued. DLT for this study is defined as the occurrence of a severe adverse event (AE) that is at least possibly related to pembrolizumab, and occurs from the initiation of treatment thru 30 days after the final administration of the study treatment
Outcome measures
| Measure |
Pembrolizumab + Post Operative Radiotherapy
n=18 Participants
IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks
Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion
IMRT 60-66Gy: 60-66Gy for 6 weeks
|
|---|---|
|
Number of Subjects With Dose Limiting Toxicities
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year after beginning treatmentPopulation: Participants enrolled in the study, excluding one participant who had disease progression prior to completing treatment.
Progression-free survival (PFS) will be calculated from treatment initiation to disease progression or death from any cause or last follow up
Outcome measures
| Measure |
Pembrolizumab + Post Operative Radiotherapy
n=18 Participants
IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks
Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion
IMRT 60-66Gy: 60-66Gy for 6 weeks
|
|---|---|
|
Number of Participants With Progression Free Survival
|
17 Participants
|
Adverse Events
Pembrolizumab + Post Operative Radiotherapy
Serious events: 3 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Pembrolizumab + Post Operative Radiotherapy
n=18 participants at risk
IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks
Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion
IMRT 60-66Gy: 60-66Gy for 6 weeks
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Infections and infestations
Urinary tract infection
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Infections and infestations
Abdominal infection
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
Other adverse events
| Measure |
Pembrolizumab + Post Operative Radiotherapy
n=18 participants at risk
IMRT 60-66Gy for 6 weeks in combination with Pembrolizumab every 3 weeks for 16 weeks
Pembrolizumab: 200mg every 3 weeks for 16 weeks given by IV infusion
IMRT 60-66Gy: 60-66Gy for 6 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
6/18 • Number of events 6 • Up to 4 weeks after the last dose of trial treatment
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Endocrine disorders
Hyperthyroidism
|
16.7%
3/18 • Number of events 3 • Up to 4 weeks after the last dose of trial treatment
|
|
Endocrine disorders
Hypothyroidism
|
27.8%
5/18 • Number of events 5 • Up to 4 weeks after the last dose of trial treatment
|
|
Eye disorders
Dry eye
|
5.6%
1/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Eye disorders
Subjunctival hemorrhage
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
4/18 • Number of events 5 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Dry mouth
|
55.6%
10/18 • Number of events 15 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
3/18 • Number of events 3 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Esophageal pain
|
5.6%
1/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Flatulence
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Gingival pain
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
6/18 • Number of events 8 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Nausea
|
33.3%
6/18 • Number of events 10 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
General disorders
Chills
|
5.6%
1/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
General disorders
Edema face
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
General disorders
Fatigue
|
72.2%
13/18 • Number of events 24 • Up to 4 weeks after the last dose of trial treatment
|
|
General disorders
Fever
|
5.6%
1/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
General disorders
Neck edema
|
11.1%
2/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Hepatobiliary disorders
Hepatic pain
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Infections and infestations
Mucosal infection
|
5.6%
1/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Infections and infestations
Otitis externa
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Infections and infestations
Rash pustular
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
83.3%
15/18 • Number of events 35 • Up to 4 weeks after the last dose of trial treatment
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Injury, poisoning and procedural complications
Seroma
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
2/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Investigations
Alkaline phosphatase increased
|
11.1%
2/18 • Number of events 6 • Up to 4 weeks after the last dose of trial treatment
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
3/18 • Number of events 5 • Up to 4 weeks after the last dose of trial treatment
|
|
Investigations
Creatinine increased
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Investigations
Lymphocyte count decreased
|
77.8%
14/18 • Number of events 30 • Up to 4 weeks after the last dose of trial treatment
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Investigations
Weight gain
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Investigations
Weight loss
|
38.9%
7/18 • Number of events 14 • Up to 4 weeks after the last dose of trial treatment
|
|
Investigations
White blood cell decreased
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
9/18 • Number of events 16 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
6/18 • Number of events 8 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
2/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
2/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
2/18 • Number of events 3 • Up to 4 weeks after the last dose of trial treatment
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Nervous system disorders
Dysgeusia
|
77.8%
14/18 • Number of events 24 • Up to 4 weeks after the last dose of trial treatment
|
|
Nervous system disorders
Headache
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
2/18 • Number of events 3 • Up to 4 weeks after the last dose of trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
1/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
16.7%
3/18 • Number of events 6 • Up to 4 weeks after the last dose of trial treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.1%
2/18 • Number of events 3 • Up to 4 weeks after the last dose of trial treatment
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
5.6%
1/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
5.6%
1/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
5.6%
1/18 • Number of events 2 • Up to 4 weeks after the last dose of trial treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
2/18 • Number of events 4 • Up to 4 weeks after the last dose of trial treatment
|
|
Skin and subcutaneous tissue disorders
verrucas lesion ~1cm behind left ear
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1 • Up to 4 weeks after the last dose of trial treatment
|
Additional Information
Dr. Shlomo Koyfman
Cleveland Clinic, Case Comprehensive Cancer Center
Phone: 1-866-223-8100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place