Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Interventions
- Registration Number
- NCT06384820
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice
- Tumor biopsy is required during screening period as described in the protocol
- Participant is willing to undergo delayed surgery
- At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function as described in the protocol
Key
- Stage I or II CSCC
- Anogenital, penile, vermilion lip CSCC
- CSCC bone invasion
- Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol
- Prior radiation therapy for CSCC
- Myocardial infarction within 6 months of enrollment, or history of myocarditis.
- 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/Exclusion Criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cemiplimab cemiplimab - fianlimab+cemiplimab fianlimab - fianlimab+cemiplimab cemiplimab -
- Primary Outcome Measures
Name Time Method Pathological complete response (pCR) rate by blinded independent pathological review (BIPR) Up to 100 days
- Secondary Outcome Measures
Name Time Method Incidence of ADA to other experimental agents (as applicable) 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 Occurrence of adverse event of special interest (AESI) Up to 3 years Occurrence of treatment-emergent serious adverse events (SAEs) Up to 3 years Occurrence of death due to TEAE Up to 3 years Titer of ADA to cemiplimab Up to 3 years Titer of ADA to fianlimab Up to 3 years Titer of ADA to other experimental agents (as applicable) Up to 3 years Overall survival (OS) Up to 3 years Occurrence of immune-mediated adverse events (imAEs) Up to 3 years Occurrence of treatment-related TEAEs 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 Occurrence of treatment-emergent adverse events (TEAEs) 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 laboratory abnormalities Up to 3 years Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
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 Incidence of ADA to fianlimab Up to 3 years