The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
IV infusion
Objective Response Rate (ORR)
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 32 months
Duration of Response (DOR)
For participants who demonstrated a confirmed CR or PR per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. The DOR per RECIST 1.1 as assessed by BICR is presented for all participants who experienced a confirmed CR or PR.
Time frame: Up to approximately 56 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants who have a CR or PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease). The DCR per RECIST 1.1 as assessed by BICR is presented.
Time frame: Up to approximately 56 months
Progression-free Survival (PFS)
PFS was defined as the time from first dose of study treatment to the first documented PD or death due to any cause, whichever occurred first. PFS per RECIST 1.1 as assessed by BICR is presented.
Time frame: Up to approximately 56 months
Overall Survival (OS)
OS was defined as the time from first dose of study treatment to death due to any cause. The OS for all participants is presented.
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Moores UC San Diego Cancer Center ( Site 0352)
La Jolla, California, United States
Stanford University Medical Center ( Site 0366)
Palo Alto, California, United States
St. Joseph Heritage Healthcare ( Site 0350)
Santa Rosa, California, United States
Yale University ( Site 0365)
New Haven, Connecticut, United States
Lombardi Comprehensive Cancer Center ( Site 0360)
Washington D.C., District of Columbia, United States
Indiana University Melvin and Bren Simon Cancer Center ( Site 0353)
Indianapolis, Indiana, United States
University of Kansas Cancer Center ( Site 0361)
Westwood, Kansas, United States
Massachusetts General Hospital ( Site 0362)
Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada ( Site 8001)
Las Vegas, Nevada, United States
John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0367)
Hackensack, New Jersey, United States
...and 49 more locations
Time frame: Up to approximately 56 months
Number of Participants Who Experienced One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who experienced an AE is presented.
Time frame: Up to approximately 56 months
Number of Participants Who Discontinued Study Treatment Due to AE
An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy. The number of participants who discontinued study treatment due to an AE is presented.
Time frame: Up to approximately 56 months