The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
IBI318 will be given fixed dose via intravenous (IV) infusion on Day 1 of each 14-day cycle until disease progression or loss of clinical benefit.
Sun Yat-sen University Cancer Center
Guangzhou, China
Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
RECIST version 1.1 will be used to determine ORR by IRRC
Time frame: 24 months
Investigator Assessments of Overall Response Rate
RECIST version 1.1 will be used to determine ORR by investigator
Time frame: 24 months
Duration of response
RECIST version 1.1 will be used to determine DOR by investigator and IRRC
Time frame: 24 months
PFS (progression-free survival)
RECIST version 1.1 will be used to determine PFS by investigator and IRRC
Time frame: 24 months
Overall Survival
Time frame: 24 months
AEs and SAEs
To evaluate the safety and tolerability of IBI318 \[Adverse events (AEs), Serious Adverse Events (SAEs) \]
Time frame: 30 months
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