This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
400 mg IV infusion
Placebo-matched IV infusion
University of South Alabama, Mitchell Cancer Institute ( Site 1562)
Mobile, Alabama, United States
City of Hope Medical Center ( Site 1505)
Duarte, California, United States
UCSD Moores Cancer Center ( Site 1561)
La Jolla, California, United States
UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)
Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center ( Site 1560)
Sacramento, California, United States
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
RFS as assessed by investigator was defined as the time between the date of randomization to the date of first local or regional recurrence of the index lesion, distant metastasis, or death due to any cause; whichever occurred first. Participants were analyzed in the treatment group to which they were randomized. RFS as assessed by investigator is presented.
Time frame: Up to approximately 62 months
Overall Survival (OS)
OS is the time from randomization to death due to any cause. Participants were analyzed in the treatment group to which they were randomized. OS is presented.
Time frame: Up to approximately 62 months
Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score is presented.
Time frame: Baseline and up to approximately 60 months
Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score
Change from baseline in the score of EORTC QLQ-C30 Items 1-5 is reported. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores meant a better level of function. Participants were analyzed in the treatment group to which they were randomized. Change from baseline in EORTC QLQ-C30 physical functioning is presented.
Time frame: Baseline and up to approximately 60 months
Percentage of Participants Who Experience an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who experience at least one AE is presented.
Time frame: Up to approximately 62 months
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of participants who discontinue study treatment due to an AE is presented.
Time frame: Up to approximately 19 months
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Stanford University Medical Center ( Site 1503)
Stanford, California, United States
University of Colorado Cancer Center ( Site 1506)
Aurora, Colorado, United States
Smilow Cancer Center at Yale-New Haven ( Site 1507)
New Haven, Connecticut, United States
Boca Raton Regional Hospital ( Site 1551)
Boca Raton, Florida, United States
UF Health ( Site 1511)
Gainesville, Florida, United States
...and 171 more locations