Cutaneous Squamous Cell Carcinoma
Conditions
Keywords
Neoadjuvant, Adjuvant, Surgery
Brief summary
This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a study drug or called study drugs when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC). The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery. The study is looking at several other research questions, including: * Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery * Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery * What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab * How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)
Interventions
DRUGcemiplimab
Administered Intravenous (IV) infusion every three weeks (Q3W)
DRUGfianlimab
IV infusion Q3W
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. Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice 2. Tumor biopsy is required during screening period as described in the protocol 3. Participant is willing to undergo delayed surgery 4. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 6. Adequate organ and bone marrow function as described in the protocol Key
Exclusion criteria
1. Stage I or II CSCC 2. Anogenital, penile, vermilion lip CSCC 3. CSCC bone invasion 4. Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol 5. Prior radiation therapy for CSCC 6. Myocardial infarction within 6 months of enrollment, or history of myocarditis. 7. Prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) rate by blinded independent pathological review (BIPR) | Up to 100 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Titer of ADA to fianlimab | Up to 3 years | — |
| Titer of ADA to other experimental agents (as applicable) | Up to 3 years | — |
| Occurrence of laboratory abnormalities | Up to 3 years | Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 |
| Occurrence of death due to TEAE | Up to 3 years | — |
| Occurrence of interruption of study drug(s) due to TEAEs | Up to 3 years | — |
| Occurrence of discontinuation of study drug(s) due to TEAEs | Up to 3 years | — |
| Occurrence of cancellation of surgery due to TEAE | Up to 100 days | — |
| Occurrence of delay to surgery due to TEAE | Up to 100 days | — |
| Concentrations of cemiplimab in serum | Up to 3 years | — |
| Concentrations of fianlimab in serum | Up to 3 years | — |
| Concentrations of other experimental agents (as applicable) in serum | Up to 3 years | — |
| Incidence of anti-drug antibodies (ADA) to cemiplimab | Up to 3 years | — |
| Titer of ADA to cemiplimab | Up to 3 years | — |
| pCR rate by local pathological review | Up to 100 days | — |
| Major pathological response (MPR) | Up to 100 days | — |
| Event-free survival (EFS) | Up to 3 years | — |
| Disease free survival (DFS) | Up to 3 years | — |
| Objective response rate (ORR) prior to surgery | Up to 100 days | — |
| Overall survival (OS) | Up to 3 years | — |
| Occurrence of treatment-emergent adverse events (TEAEs) | Up to 3 years | — |
| Occurrence of immune-mediated adverse events (imAEs) | Up to 3 years | — |
| Occurrence of treatment-related TEAEs | Up to 3 years | — |
| Occurrence of adverse event of special interest (AESI) | Up to 3 years | — |
| Occurrence of treatment-emergent serious adverse events (SAEs) | Up to 3 years | — |
| Incidence of ADA to other experimental agents (as applicable) | Up to 3 years | — |
| Incidence of ADA to fianlimab | Up to 3 years | — |
Outcome results
None listed