Trial Outcomes & Findings for Pembrolizumab in Patients With Locally Advanced or Metastatic Skin Cancer (NCT NCT02964559)
NCT ID: NCT02964559
Last Updated: 2024-06-26
Results Overview
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Up to 1 year after treatment discontinuation (max treatment duration of 3 years)
Results posted on
2024-06-26
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab in Patients With Locally Advanced or Metastatic Skin Cancer
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=11 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 year after treatment discontinuation (max treatment duration of 3 years)Population: all patients except patient diagnosed with covid-19
Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=11 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
|---|---|
|
Response Rate of Pembrolizumab
|
72.73 percentage of participants
Interval 39.03 to 93.98
|
SECONDARY outcome
Timeframe: Up to 1 year after treatment discontinuation (max treatment duration of 3 years)Number of patients who were alive 1 year after their respective treatment completion dates
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=11 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
|---|---|
|
Overall Survival
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 6 months after treatment discontinuation (max treatment duration of 3 years)Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Treatment (Pembrolizumab)
n=11 Participants
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Pembrolizumab: Given IV
|
|---|---|
|
Progression-free Survival
|
81.8 percentage of participants
Interval 44.7 to 95.1
|
Adverse Events
Pembrolizumab
Serious events: 6 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=11 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Nervous system disorders
Edema cerebral
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Musculoskeletal and connective tissue disorders
Fall
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Injury, poisoning and procedural complications
General disorders and administration site conditions - Other, specify
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Injury, poisoning and procedural complications
Hematoma
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Hydrocephalus
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Hypotension
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Meningitis
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Presyncope
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Seizure
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
Other adverse events
| Measure |
Pembrolizumab
n=11 participants at risk
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Endocrine disorders
Hyperglycemia
|
81.8%
9/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Endocrine disorders
Hyponatremia
|
63.6%
7/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Anemia
|
45.5%
5/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Hepatobiliary disorders
Creatinine increased
|
45.5%
5/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Gastrointestinal disorders
Diarrhea
|
36.4%
4/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Activated partial thromboplastin time prolonged
|
36.4%
4/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
36.4%
4/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
36.4%
4/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
Fatigue
|
36.4%
4/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Hepatobiliary disorders
Alkaline phosphatase increased
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
Dry mouth
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Gastrointestinal disorders
Dyspnea
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Hyperkalemia
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Hypertension
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Gastrointestinal disorders
Hyperuricemia
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Hypocalcemia
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Endocrine disorders
Hypoglycemia
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Hypomagnesemia
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
Pain
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.3%
3/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Gastrointestinal disorders
Anorexia
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Injury, poisoning and procedural complications
Bruising
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Gastrointestinal disorders
Constipation
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Infections and infestations
Cough
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Musculoskeletal and connective tissue disorders
Dysphagia
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Musculoskeletal and connective tissue disorders
Fall
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Infections and infestations
Flu like symptoms
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Hemoglobin increased
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Hypermagnesemia
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Hypokalemia
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Endocrine disorders
Hypothyroidism
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Psychiatric disorders
Insomnia
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Gastrointestinal disorders
Metabolism and nutrition disorders - Other, specify
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Renal and urinary disorders
Urine discoloration
|
18.2%
2/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Hepatobiliary disorders
Adrenal insufficiency
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Immune system disorders
Allergic reaction
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Injury, poisoning and procedural complications
Aspiration
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Eye disorders
Blurred vision
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
Chills
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
Dizziness
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Edema cerebral
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Edema limbs
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Infections and infestations
Fever
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Flushing
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Hematoma
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Hydrocephalus
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
Hypercalcemia
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Hypernatremia
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Congenital, familial and genetic disorders
Hypophosphatemia
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Hypotension
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Infections and infestations
Infections and infestations - Other, specify
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
Investigations - Other, specify
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Ear and labyrinth disorders
Laryngeal hemorrhage
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Ear and labyrinth disorders
Laryngeal inflammation
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Meningitis
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Musculoskeletal and connective tissue disorders
Movements involuntary
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Skin and subcutaneous tissue disorders
Papulopustular rash
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Paresthesia
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Ear and labyrinth disorders
Postnasal drip
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
Presyncope
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Nervous system disorders
Seizure
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Cardiac disorders
Supraventricular tachycardia
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Thromboembolic event
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Musculoskeletal and connective tissue disorders
Vascular disorders - Other, specify
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
Ventricular arrhythmia
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
General disorders
Weight loss
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
9.1%
1/11 • 1 year after treatment discontinuation (max treatment duration of 3 years)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place