Trial Outcomes & Findings for Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC) (NCT NCT04808999)

Last Updated: 2025-05-29

Results Overview

Percentage of patients with either pathologic complete response (pCR) or partial pathologic response (pPR) per Immune-Related Pathologic Response Criteria (immunotherapy-specific pathologic response criteria (irPRC) criteria. Per (irPRC), pCR = 0% residual viable tumor (RVT) remaining in post-therapy specimen (no signs of cancer) in tissue samples removed during surgery, and pPR = \>10% but ≤50% RVT remaining in post-therapy specimen in tissue samples removed during surgery.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

At time of surgery, up to 6 weeks post-baseline

Results posted on

2025-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Pembrolizumab Neoadjuvant Phase: 200 mg IV infusion, every 3 weeks (Day 1 of each 3-week cycle, 2 cycles) Adjuvant Phase: Day 1 of each 3-week cycle, 15 cycles Pembrolizumab Injection: 200 mg IV infusion
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab n=30 Participants Neoadjuvant Phase: 200 mg IV infusion, every 3 weeks (Day 1 of each 3-week cycle, 2 cycles) Adjuvant Phase: Day 1 of each 3-week cycle, 15 cycles Pembrolizumab Injection: 200 mg IV infusion
Age, Continuous	76.5 years STANDARD_DEVIATION 9.18 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 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	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At time of surgery, up to 6 weeks post-baseline

Population: Treated patients evaluable for pathologic complete response (pCR) at the time of their surgery.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=27 Participants Neoadjuvant Phase: 200 mg IV infusion, every 3 weeks (Day 1 of each 3-week cycle, 2 cycles) Adjuvant Phase: Day 1 of each 3-week cycle, 15 cycles Pembrolizumab Injection: 200 mg IV infusion
Pathologic Response pCR	63.0 percentage of patients Interval 42.4 to 80.6
Pathologic Response pPR	7.4 percentage of patients Interval 0.9 to 24.3

PRIMARY outcome

Timeframe: At time of surgery

Population: Treated patients evaluable for pathologic complete response (pCR) at the time of their surgery.

Number of patients with pathologic complete response (pCR), partial pathologic response (pPR), pathologic non-response (pNR) per Immune-Related Pathologic Response Criteria ((irPRC) criteria. Per (irPRC), pCR = 0% residual viable tumor (RVT) (no signs of cancer), pPR = \>10% but ≤50% RVT, or pNR = \>50% RVT remaining in post-therapy specimen tissue samples removed during surgery.

Outcome measures

Outcome measures
Measure	Pembrolizumab n=27 Participants Neoadjuvant Phase: 200 mg IV infusion, every 3 weeks (Day 1 of each 3-week cycle, 2 cycles) Adjuvant Phase: Day 1 of each 3-week cycle, 15 cycles Pembrolizumab Injection: 200 mg IV infusion
Response Assessment Per Immune-Related Pathologic Response Criteria (irPRC) pCR	17 Participants
Response Assessment Per Immune-Related Pathologic Response Criteria (irPRC) pPR	2 Participants
Response Assessment Per Immune-Related Pathologic Response Criteria (irPRC) pNR	8 Participants

SECONDARY outcome

Timeframe: Up to 60 months

The median length of time from initiation of study drug(s) until disease relapse (disease progression) as defined by RECIST v1.1, or death. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

The proportion of patients whose disease does not progress/relapse (as defined by RECIST v1.1), or cease to breath at 1 year after the initiation of treatment. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 6 months

The proportion of patients whose disease does not progress/relapse (as defined by RECIST v1.1), or cease to breath at 6 months after the initiation of treatment. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

The proportion of patients whose disease does not progress (as defined by RECIST v1.1), or cease to breath at 2 years after the initiation of treatment. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 36 months

The proportion of patients whose disease does not progress/relapse (as defined by RECIST v1.1), or cease to breath at 3 years after the initiation of treatment. Progressive Disease (PD): ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The sum must also demonstrate an absolute increase of ≥5 mm. The appearance ≥1 new lesion(s) is considered progression.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 84 months

The median length of time from initiation of study treatment that patients remain alive.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

The proportion of patients alive at 1 year after the initiation of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

The proportion of patients alive at 2 years after the initiation of treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From start of treatment, up to 24 months

Number of patients with response per Immune-Related Pathologic Response Criteria (irPRC) criteria: major pathologic response (\<0 to ≤10% RVT); partial pathologic response (\<10 to ≤50% RVT).

Outcome measures

Outcome data not reported

Adverse Events

Pembrolizumab

Serious events: 13 serious events

Other events: 29 other events

Deaths: 6 deaths

Serious adverse events

Serious adverse events
Measure	Pembrolizumab n=30 participants at risk Neoadjuvant Phase: 200 mg IV infusion, every 3 weeks (Day 1 of each 3-week cycle, 2 cycles) Adjuvant Phase: Day 1 of each 3-week cycle, 15 cycles Pembrolizumab Injection: 200 mg IV infusion
Cardiac disorders Cardiac arrest	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Cardiac disorders Heart failure	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Cardiac disorders Mobitz (type) II atrioventricular block	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Cardiac disorders Myocardial infarction	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Cardiac disorders Myocarditis	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders GI bleed	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders Pain	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Infections and infestations Hepatitis viral	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Infections and infestations COVID-19	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Infections and infestations Urinary tract infection	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Injury, poisoning and procedural complications Fall	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Blood bilirubin increased	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypercalcemia	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Nervous system disorders metabolic encephalopathy	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders nephritis	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Aspiration	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Surgical and medical procedures skin graft surgery	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Vascular disorders Thromboembolic event	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.

Other adverse events

Other adverse events
Measure	Pembrolizumab n=30 participants at risk Neoadjuvant Phase: 200 mg IV infusion, every 3 weeks (Day 1 of each 3-week cycle, 2 cycles) Adjuvant Phase: Day 1 of each 3-week cycle, 15 cycles Pembrolizumab Injection: 200 mg IV infusion
Blood and lymphatic system disorders Anemia	56.7% 17/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Blood and lymphatic system disorders Eosinophilia	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Blood and lymphatic system disorders Leukocytosis	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Cardiac disorders Aortic valve disease	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Cardiac disorders coronary artery disease	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Cardiac disorders Heart failure	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Cardiac disorders Sinus bradycardia	16.7% 5/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Cardiac disorders Sinus tachycardia	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Ear and labyrinth disorders ear congestion	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Ear and labyrinth disorders Hearing impaired	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Ear and labyrinth disorders Vertigo	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Endocrine disorders Adrenal insufficiency	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Endocrine disorders Hyperthyroidism	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Endocrine disorders Hypothyroidism	16.7% 5/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Eye disorders Eyelid function disorder	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Abdominal pain	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Colitis	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Constipation	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Diarrhea	23.3% 7/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Dry mouth	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Dyspepsia	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Dysphagia	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Flatulence	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Gastroesophageal reflux disease	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Mucositis oral	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Nausea	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Oral pain	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Gastrointestinal disorders Vomiting	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders Edema limbs	20.0% 6/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders Fatigue	40.0% 12/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders Fever	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders Flu like symptoms	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders Gait disturbance	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders edema - tumor site	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders erythema - right upper extremity	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders wound vac at surgical site	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders Localized edema	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders Malaise	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
General disorders Pain	33.3% 10/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Immune system disorders immune mediated hepatitis	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Infections and infestations COVID-19	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Infections and infestations aspiration pneumonia	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Infections and infestations infection - right neck	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Infections and infestations skin graft to back of head	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Infections and infestations Lung infection	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Infections and infestations Urinary tract infection	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Injury, poisoning and procedural complications Dermatitis radiation	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Injury, poisoning and procedural complications Fall	20.0% 6/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Injury, poisoning and procedural complications Fracture	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Injury, poisoning and procedural complications Wound complication	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Activated partial thromboplastin time prolonged	23.3% 7/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Alanine aminotransferase increased	16.7% 5/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Alkaline phosphatase increased	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Aspartate aminotransferase increased	26.7% 8/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Blood bilirubin increased	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Blood lactate dehydrogenase increased	50.0% 15/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations CPK increased	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Cardiac troponin I increased	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Creatinine increased	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Hemoglobin increased	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations INR increased	16.7% 5/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Gout	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Lichen-planus-like keratosis right shoulder	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Thyroid surgery	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations multiple actinic keratosis of face and scalp	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations multiple benign melanocytic nevi	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations new primary SCC left neck	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations new primary SCC right mandible	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations seborrheic keratosis	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations tumor drainage - clear thick in color	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations tumor erythema	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Lymphocyte count decreased	30.0% 9/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Lymphocyte count increased	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Neutrophil count decreased	16.7% 5/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Platelet count decreased	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Thyroid stimulating hormone increased	26.7% 8/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations Weight loss	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Investigations White blood cell decreased	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Anorexia	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypercalcemia	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hyperglycemia	50.0% 15/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hyperkalemia	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hyperlipidemia	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypermagnesemia	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypernatremia	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hyperphosphatemia	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hyperuricemia	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 6/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypocalcemia	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypoglycemia	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypokalemia	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypomagnesemia	26.7% 8/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hyponatremia	50.0% 15/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders Hypophosphatemia	23.3% 7/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Metabolism and nutrition disorders latent autoimmune diabetes in adults	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Musculoskeletal and connective tissue disorders Arthralgia	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Musculoskeletal and connective tissue disorders Myalgia	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Musculoskeletal and connective tissue disorders Neck pain	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Musculoskeletal and connective tissue disorders Pain in extremity	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) EMZL MALT lymphoma	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) basal cell carcinoma of left nasal sidewall and left neck	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) left lateral shoulder SCC	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Nervous system disorders Dizziness	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Nervous system disorders Dysgeusia	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Nervous system disorders Facial muscle weakness	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Nervous system disorders Headache	16.7% 5/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Nervous system disorders Paresthesia	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Psychiatric disorders Anxiety	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Psychiatric disorders Confusion	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Psychiatric disorders Depression	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Psychiatric disorders Insomnia	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders Acute kidney injury	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders Chronic kidney disease	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders Glucosuria	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders Hematuria	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders Proteinuria	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders Ua Specific Gravity increased	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders Ua Specific Gravity low	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders blood urea nitrogen (BUN) increased	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders specify increased specific gravity	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders renal cysts	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Atelectasis	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Cough	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Dyspnea	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Hiccups	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Hypoxia	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Pleural effusion	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Postnasal drip	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Productive cough	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders Dry skin	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders Erythema multiforme	10.0% 3/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders Pruritus	26.7% 8/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders Rash acneiform	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders Rash maculo-papular	26.7% 8/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders actinic keratosis	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders bactrim rash	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders skin infection (cellulitus)	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders Skin ulceration	6.7% 2/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Skin and subcutaneous tissue disorders Urticaria	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Surgical and medical procedures contrast infiltration	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Surgical and medical procedures ectropian right lower eyelid/dehiscence of right cheek surgical wound	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Surgical and medical procedures oral fiberoptic bronchoscopy	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Vascular disorders Hypertension	30.0% 9/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Vascular disorders Hypotension	13.3% 4/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Vascular disorders Thromboembolic event	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.
Renal and urinary disorders increased specific gravity	3.3% 1/30 • Adverse Events data collected for a total of approximately 45 months for the study population. Up to approximately 16 months after start of treatment for individuals.

Additional Information

Barbara Stadterman, MPH, MSCCR, CCRP, Clinical Research Manager

UPMC Hillman Cancer Center

Phone: 4126475554

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place