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Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) or Locally Advanced Unresectable cSCC (MK-3475-629/KEYNOTE-629)

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ClinicalTrials.gov Identifier: NCT03284424
Recruitment Status : Active, not recruiting
First Posted : September 15, 2017
Results First Posted : November 19, 2021
Last Update Posted : July 1, 2022
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Squamous Cell Carcinoma
Intervention Biological: Pembrolizumab
Enrollment 159
Recruitment Details  
Pre-assignment Details There were 2 cohorts in this study and each cohort received the same dose/treatment regimen. Participant flow, baseline characteristics, and outcome measures are presented by cohort. Adverse events were pre-specified to be reported as a single group by intervention. Results are from database cutoff date of 29-Jul-2020.
Arm/Group Title Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort Locally Advanced Unresectable cSCC Cohort
Hide Arm/Group Description Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle. Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
Period Title: Overall Study
Started 105 54
Completed 0 0
Not Completed 105 54
Reason Not Completed
Death             56             13
Lost to Follow-up             1             0
Physician Decision             1             0
Withdrawal by Subject             3             2
Ongoing in study             44             39
Arm/Group Title Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) Cohort Locally Advanced Unresectable cSCC Cohort Total
Hide Arm/Group Description Participants received pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle. Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle. Total of all reporting groups
Overall Number of Baseline Participants 105 54 159
Hide Baseline Analysis Population Description
The analysis population consisted of all participants who received ≥1 dose of study treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 54 participants 159 participants
70.0  (14.3) 73.7  (12.4) 71.3  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 54 participants 159 participants
Female
25
  23.8%
15
  27.8%
40
  25.2%
Male
80
  76.2%
39
  72.2%
119
  74.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 54 participants 159 participants
Hispanic or Latino
13
  12.4%
2
   3.7%
15
   9.4%
Not Hispanic or Latino
57
  54.3%
41
  75.9%
98
  61.6%
Unknown or Not Reported
35
  33.3%
11
  20.4%
46
  28.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 54 participants 159 participants
American Indian or Alaska Native
3
   2.9%
1
   1.9%
4
   2.5%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.0%
0
   0.0%
1
   0.6%
Black or African American
0
   0.0%
1
   1.9%
1
   0.6%
White
74
  70.5%
45
  83.3%
119
  74.8%
More than one race
1
   1.0%
0
   0.0%
1
   0.6%
Unknown or Not Reported
26
  24.8%
7
  13.0%
33
  20.8%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants who have best response of Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). ORR per RECIST 1.1 as assessed by blinded independent central review (BICR) is presented.
Time Frame Up to approximately 31.8 months (database cutoff date 29-Jul-2020)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all participants who received ≥1 dose of study treatment.
Arm/Group Title Recurrent or Metastatic cSCC Cohort Locally Advanced Unresectable cSCC Cohort
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
Overall Number of Participants Analyzed 105 54
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
35.2
(26.2 to 45.2)
50.0
(36.1 to 63.9)
2.Secondary Outcome
Title Duration of Response (DOR)
Hide Description [Not Specified]
Time Frame Up to approximately 56 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description [Not Specified]
Time Frame Up to approximately 56 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description [Not Specified]
Time Frame Up to approximately 56 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description [Not Specified]
Time Frame Up to approximately 56 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Number of Participants Who Experienced One or More Adverse Events (AEs)
Hide Description [Not Specified]
Time Frame Up to approximately 56 months
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
Hide Description [Not Specified]
Time Frame Up to approximately 56 months
Outcome Measure Data Not Reported
Time Frame Through database cutoff date of 29-July-2020 (up to approximately 31.8 months)
Adverse Event Reporting Description The analysis population for adverse events (AEs) included all participants who received ≥1 dose of study treatment. Adverse Events were pre-specified to be reported as a single group by intervention. Per protocol, disease progression was not considered an AE unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "neoplasm progression (NP)", "malignant NP" and "disease progression" not related to study treatment are excluded.
 
Arm/Group Title Pembrolizumab 200 mg
Hide Arm/Group Description Participants received pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle.
All-Cause Mortality
Pembrolizumab 200 mg
Affected / at Risk (%)
Total   73/159 (45.91%)    
Hide Serious Adverse Events
Pembrolizumab 200 mg
Affected / at Risk (%) # Events
Total   73/159 (45.91%)    
Blood and lymphatic system disorders   
Anaemia  1  3/159 (1.89%)  3
Haemolytic anaemia  1  1/159 (0.63%)  2
Cardiac disorders   
Acute myocardial infarction  1  1/159 (0.63%)  1
Angina pectoris  1  1/159 (0.63%)  1
Atrial fibrillation  1  2/159 (1.26%)  2
Cardiac failure  1  2/159 (1.26%)  2
Cardiac failure chronic  1  1/159 (0.63%)  1
Coronary artery disease  1  1/159 (0.63%)  1
Myocardial infarction  1  2/159 (1.26%)  2
Ventricular extrasystoles  1  1/159 (0.63%)  1
Endocrine disorders   
Adrenal insufficiency  1  1/159 (0.63%)  1
Lymphocytic hypophysitis  1  1/159 (0.63%)  1
Gastrointestinal disorders   
Abdominal pain lower  1  1/159 (0.63%)  1
Abdominal wall haemorrhage  1  1/159 (0.63%)  1
Colitis  1  2/159 (1.26%)  2
Constipation  1  1/159 (0.63%)  1
Duodenal ulcer perforation  1  1/159 (0.63%)  1
Dysphagia  1  1/159 (0.63%)  1
Large intestine perforation  1  2/159 (1.26%)  2
Nausea  1  1/159 (0.63%)  1
Oral pain  1  1/159 (0.63%)  1
Vomiting  1  1/159 (0.63%)  1
General disorders   
Asthenia  1  1/159 (0.63%)  1
Death  1  1/159 (0.63%)  1
General physical health deterioration  1  1/159 (0.63%)  1
Hepatobiliary disorders   
Autoimmune hepatitis  1  1/159 (0.63%)  1
Immune system disorders   
Anaphylactic reaction  1  1/159 (0.63%)  1
Infections and infestations   
Abscess neck  1  1/159 (0.63%)  1
Appendicitis perforated  1  1/159 (0.63%)  1
Arthritis bacterial  1  1/159 (0.63%)  1
Bacteraemia  1  1/159 (0.63%)  1
COVID-19  1  1/159 (0.63%)  1
Cellulitis  1  1/159 (0.63%)  1
Clostridium difficile infection  1  1/159 (0.63%)  1
Dermo-hypodermitis  1  1/159 (0.63%)  1
Device related sepsis  1  1/159 (0.63%)  1
Fungal skin infection  1  1/159 (0.63%)  1
Gastroenteritis salmonella  1  1/159 (0.63%)  1
Infection  1  1/159 (0.63%)  1
Infestation  1  1/159 (0.63%)  1
Lower respiratory tract infection  1  1/159 (0.63%)  1
Oral candidiasis  1  1/159 (0.63%)  1
Otitis externa  1  1/159 (0.63%)  1
Pneumonia  1  5/159 (3.14%)  5
Respiratory tract infection  1  1/159 (0.63%)  1
Sepsis  1  3/159 (1.89%)  3
Septic shock  1  1/159 (0.63%)  1
Soft tissue infection  1  1/159 (0.63%)  1
Subcutaneous abscess  1  1/159 (0.63%)  1
Urinary tract infection  1  2/159 (1.26%)  2
Wound infection  1  1/159 (0.63%)  1
Injury, poisoning and procedural complications   
Head injury  1  1/159 (0.63%)  1
Hip fracture  1  1/159 (0.63%)  1
Infusion related reaction  1  1/159 (0.63%)  1
Joint injury  1  1/159 (0.63%)  1
Radiation necrosis  1  1/159 (0.63%)  1
Subdural haematoma  1  1/159 (0.63%)  1
Toxicity to various agents  1  1/159 (0.63%)  1
Wound complication  1  1/159 (0.63%)  1
Investigations   
Blood creatine increased  1  1/159 (0.63%)  1
Transaminases increased  1  3/159 (1.89%)  3
Metabolism and nutrition disorders   
Diabetic ketoacidosis  1  1/159 (0.63%)  3
Hyponatraemia  1  1/159 (0.63%)  1
Hypophagia  1  1/159 (0.63%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/159 (0.63%)  1
Back pain  1  1/159 (0.63%)  1
Groin pain  1  1/159 (0.63%)  1
Osteoarthritis  1  1/159 (0.63%)  1
Pain in extremity  1  1/159 (0.63%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  2/159 (1.26%)  2
Infected neoplasm  1  3/159 (1.89%)  3
Myelodysplastic syndrome  1  1/159 (0.63%)  1
Neoplasm recurrence  1  1/159 (0.63%)  1
Neuroendocrine carcinoma of the skin  1  1/159 (0.63%)  1
Tumour haemorrhage  1  2/159 (1.26%)  2
Tumour pain  1  1/159 (0.63%)  1
Nervous system disorders   
Cerebrospinal fluid leakage  1  1/159 (0.63%)  1
Cranial nerve disorder  1  1/159 (0.63%)  1
Dementia  1  1/159 (0.63%)  1
Epilepsy  1  1/159 (0.63%)  1
Neuropathy peripheral  1  1/159 (0.63%)  1
Peripheral sensory neuropathy  1  1/159 (0.63%)  1
Transient ischaemic attack  1  1/159 (0.63%)  1
Renal and urinary disorders   
Acute kidney injury  1  1/159 (0.63%)  1
Autoimmune nephritis  1  1/159 (0.63%)  1
Nephrolithiasis  1  1/159 (0.63%)  1
Prerenal failure  1  1/159 (0.63%)  1
Urinary retention  1  1/159 (0.63%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  1/159 (0.63%)  1
Dyspnoea  1  1/159 (0.63%)  1
Epistaxis  1  1/159 (0.63%)  1
Lung disorder  1  1/159 (0.63%)  1
Pleural effusion  1  1/159 (0.63%)  1
Pneumonia aspiration  1  1/159 (0.63%)  1
Pneumonitis  1  2/159 (1.26%)  2
Pulmonary embolism  1  1/159 (0.63%)  2
Respiratory failure  1  1/159 (0.63%)  1
Skin and subcutaneous tissue disorders   
Rash  1  1/159 (0.63%)  1
Vascular disorders   
Peripheral ischaemia  1  1/159 (0.63%)  1
Superior vena cava occlusion  1  1/159 (0.63%)  1
Temporal arteritis  1  1/159 (0.63%)  1
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab 200 mg
Affected / at Risk (%) # Events
Total   139/159 (87.42%)    
Blood and lymphatic system disorders   
Anaemia  1  17/159 (10.69%)  24
Endocrine disorders   
Hypothyroidism  1  14/159 (8.81%)  16
Gastrointestinal disorders   
Abdominal pain  1  13/159 (8.18%)  14
Constipation  1  40/159 (25.16%)  46
Diarrhoea  1  31/159 (19.50%)  38
Nausea  1  23/159 (14.47%)  29
Vomiting  1  16/159 (10.06%)  22
General disorders   
Asthenia  1  33/159 (20.75%)  42
Chest pain  1  8/159 (5.03%)  8
Fatigue  1  35/159 (22.01%)  39
Oedema peripheral  1  15/159 (9.43%)  19
Pyrexia  1  14/159 (8.81%)  17
Infections and infestations   
Bronchitis  1  8/159 (5.03%)  8
Injury, poisoning and procedural complications   
Fall  1  11/159 (6.92%)  13
Investigations   
Blood creatinine increased  1  8/159 (5.03%)  8
Weight decreased  1  17/159 (10.69%)  18
Metabolism and nutrition disorders   
Decreased appetite  1  26/159 (16.35%)  28
Hypercalcaemia  1  9/159 (5.66%)  11
Musculoskeletal and connective tissue disorders   
Arthralgia  1  19/159 (11.95%)  23
Back pain  1  12/159 (7.55%)  13
Neck pain  1  8/159 (5.03%)  8
Pain in extremity  1  25/159 (15.72%)  28
Nervous system disorders   
Dizziness  1  11/159 (6.92%)  12
Headache  1  16/159 (10.06%)  18
Psychiatric disorders   
Insomnia  1  10/159 (6.29%)  10
Respiratory, thoracic and mediastinal disorders   
Cough  1  19/159 (11.95%)  22
Dyspnoea  1  12/159 (7.55%)  12
Skin and subcutaneous tissue disorders   
Actinic keratosis  1  8/159 (5.03%)  13
Dry skin  1  10/159 (6.29%)  10
Pruritus  1  39/159 (24.53%)  44
Rash  1  22/159 (13.84%)  31
Skin lesion  1  12/159 (7.55%)  23
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If publication activity is not directed by the sponsor, the investigator agrees to submit all manuscripts or abstracts to the sponsor before submission. This allows the sponsor to protect proprietary information and to provide comments.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT03284424    
Other Study ID Numbers: 3475-629
MK-3475-629 ( Other Identifier: Merck )
KEYNOTE-629 ( Other Identifier: Merck )
2017-000594-37 ( EudraCT Number )
First Submitted: September 14, 2017
First Posted: September 15, 2017
Results First Submitted: September 14, 2021
Results First Posted: November 19, 2021
Last Update Posted: July 1, 2022