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
Histologic confirmation of BCC by local board-certified pathologist, as described in the protocol
At least one lesion that is measurable by study criteria, defined as ≥ 1cm in at least one dimension, as assessed by radiology and/or digital medical photography, as described in the protocol
The treating physician must document that the participant is not appropriate for curative-intent surgery or curative-intent radiation
The treating physician must document that the participant does not wish to receive a hedgehog pathway inhibitor (HHI) or is not a candidate for an HHI
Metastatic disease to lymph node(s) or distant site(s) (Note: involvement of lymph node due to direct invasion from overlying cutaneous BCC is still considered laBCC, and is not excluded)
History or current evidence of significant cardiovascular disease, as described in the protocol
Exposure to any prior systemic therapy (eg, HHI or an immune checkpoint inhibitor) or locally injectable agent for laBCC, as described in the protocol
Current participation OR past participation in another investigational trial in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical trial.
Parallel
Cemiplimab
DrugAdministered per the protocol
Vidutolimod
DrugAdministered per the protocol
Fianlimab
DrugAdministered 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 \[modified World Health Organization (WHO) criteria\].
Duration of Response (DOR) by BICR per Composite Response Criteria
Time to Response (TTR) by BICR per Composite Response Criteria
Best Overall Response (BOR) of Complete Response (CR) by BICR per composite Response Criteria
Progression-Free Survival (PFS) by BICR per Composite Response Criteria
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This trial is not recruiting at the moment. You can still explore other options:
