This study will test an experimental Regeneron drug called cemiplimab ("study drug") given alone or in combination with other anti-cancer drugs ("combination treatment") to see if they can help treat laBCC. The study is looking at: * What side effects cemiplimab, alone or in a combination treatment, might cause * How well cemiplimab, alone or in a combination treatment, works * How cemiplimab, alone or in a combination treatment could affect the immune system, which can help researchers understand why cemiplimab, alone or in a combination treatment, works better in some participants than others
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Administered per the protocol
Administered per the protocol
Administered per the protocol
Objective Response Rate (ORR) by blinded independent central review (BICR) per Composite Response Criteria
Composite Response Criteria integrates radiology findings \[Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\] and external lesion assessments from digital photography \[modified World Health Organization (WHO) criteria\].
Time frame: Up to approximately 3 years
Duration of Response (DOR) by BICR per Composite Response Criteria
Time frame: Up to approximately 3 years
Time to Response (TTR) by BICR per Composite Response Criteria
Time frame: Up to approximately 3 years
Best Overall Response (BOR) of Complete Response (CR) by BICR per composite Response Criteria
Time frame: Up to approximately 3 years
Progression-Free Survival (PFS) by BICR per Composite Response Criteria
Time frame: Up to approximately 3 years
Objective Response by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
DOR by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
TTR by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
Complete Response (CR) by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
PFS by investigator review per Composite Response Criteria
Time frame: Up to approximately 3 years
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3 years
Severity of TEAEs
Time frame: Up to approximately 3 years
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