Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
Conditions
Keywords
CSCC, BCC
Brief summary
This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC). The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810). The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks. The study is also looking at several other research questions, including: * What side effects may happen from taking the study drug * To see effect of cemiplimab on the tumor * How much study drug is in the blood at different times
Interventions
DRUGCemiplimab
Each patient will receive intralesional injections of cemiplimab every week (QW), or at less frequent dosing into the lesion at the assigned dose level for 3-12 weeks prior to scheduled surgery
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cohorts A, B, D and H will enroll sequentially (not randomized). Cohort C and I for BCC will enroll in parallel with, and independently of, Cohorts A, B, D and H for CSCC patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria 1. Dose Escalation: History of recurrent resectable CSCC or BCC (Cohort C and I only) that satisfies conditions as defined in the protocol 2. Patients must have measurable disease in the index lesion, defined as 1-2 cm in the longest diameter 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Key
Exclusion criteria
1. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-mediated adverse events (imAEs) 2. Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway. 3. Prior treatment with other systemic immune modulating agent as defined in the protocol 4. M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years 5. Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded. 6. Patients with a history of solid organ transplant 7. Has received a Coronavirus induced disease of 2019 (COVID-19) vaccination (initial series and booster) within 1 week of planned start of study medication Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of TEAEs graded according to the NCI CTCAE v5 | From the first dose up to 90 days after the last dose | — |
| The incidence and severity of injection site reactions (ISRs) | From the first dose to 90 days after the last dose | — |
| Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 | From the first dose through day 28 | Dose levels 1-3 |
| Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 | From the first dose to 90 days after the last dose | Dose levels 1-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) of index lesion | At baseline and at Week 13 | Determined by the investigator using the modified World Health Organization (WHO) criteria |
| Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion | At time of surgery | — |
| Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations | Up to 90 days after last dose | The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme. |
| Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery) in index lesion | At time of surgery | — |
| Cemiplimab concentration in serum over time | From the first dose up to 90 days after the last dose | — |
| Incidence of anti-drug antibody (ADA) titers for cemiplimab | Up to 90 days after last dose | — |
Countries
Australia, Netherlands, United States
Contacts
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed