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)

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06384820
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • cemiplimab — DRUG
    Administered Intravenous (IV) infusion every three weeks (Q3W)
  • fianlimab — DRUG
    IV infusion Q3W

Study Details

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)

Key Dates

Start date
Nov 14, 2024
Status verified
Jul 2024
Primary completion
Jun 8, 2026
Completion
May 6, 2030

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: cemiplimab
  • Experimental: fianlimab+cemiplimab

Primary Outcome Measure

Pathological complete response (pCR) rate by blinded independent pathological review (BIPR) [ Time Frame: Up to 100 days ]

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