Locally Advanced Basal Cell Carcinoma
Conditions
Keywords
BCC, laBCC, Skin Cancer, Non-melanoma skin cancer, Surgically unresectable, Unsuitable for radiotherapy, Inoperable Basal Cell Carcinoma, Recurrent Basal Cell Carcinoma, Cutaneous Basal Cell Carcinoma, Keratinocyte Carcinoma, High-Risk Basal Cell Carcinoma
Brief summary
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
Interventions
DRUGCemiplimab
Administered per the protocol
DRUGVidutolimod
Administered per the protocol
DRUGFianlimab
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Histologic confirmation of BCC by local board-certified pathologist, as described in the protocol 2. 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 3. The treating physician must document that the participant is not appropriate for curative-intent surgery or curative-intent radiation 4. 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 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 Subsequent Therapy Arm - specific inclusion criteria: 1. Documentation of histopathologic diagnosis of basal cell carcinoma - NOT necessary 2. Submission of tumor or blood for exploratory correlative research - NOT necessary Key
Exclusion criteria
1. 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) 2. History or current evidence of significant cardiovascular disease, as described in the protocol 3. Exposure to any prior systemic therapy (eg, HHI or an immune checkpoint inhibitor) or locally injectable agent for laBCC, as described in the protocol 4. 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. Subsequent Therapy Arm - specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) by blinded independent central review (BICR) per Composite Response Criteria | Up to approximately 3 years | Composite Response Criteria integrates radiology findings \[Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\] and external lesion assessments from digital photography \[modified World Health Organization (WHO) criteria\]. |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR) by BICR per Composite Response Criteria | Up to approximately 3 years |
| Time to Response (TTR) by BICR per Composite Response Criteria | Up to approximately 3 years |
| Best Overall Response (BOR) of Complete Response (CR) by BICR per composite Response Criteria | Up to approximately 3 years |
| Progression-Free Survival (PFS) by BICR per Composite Response Criteria | Up to approximately 3 years |
| Objective Response by investigator review per Composite Response Criteria | Up to approximately 3 years |
| DOR by investigator review per Composite Response Criteria | Up to approximately 3 years |
| TTR by investigator review per Composite Response Criteria | Up to approximately 3 years |
| Complete Response (CR) by investigator review per Composite Response Criteria | Up to approximately 3 years |
| PFS by investigator review per Composite Response Criteria | Up to approximately 3 years |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 3 years |
| Severity of TEAEs | Up to approximately 3 years |
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed