Cutaneous Squamous Cell Carcinoma study: Cemiplimab
Official title Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06585410
What this study is testing
What is Cemiplimab?
An investigational injectable medicine being studied as a potential treatment for early‑stage cutaneous squamous cell carcinoma (CSCC). It is designed to bind to the PD‑1 protein on immune cells, helping the immune system recognize and kill cancer cells.
Also referred to as Libtayo.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well cemiplimab works and how safe it is compared with standard surgery for early‑stage cutaneous squamous cell carcinoma.
- Who it's for
- Adults who have early‑stage cutaneous squamous cell carcinoma.
- What's involved
- Participants receive cemiplimab injected directly into the tumor and may also undergo surgery, with follow‑up visits and safety tests.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants who have a histologically confirmed invasive CSCC TL, as described in the protocol
- Participants who have CSCC TL ≥1 cm and ≤2.0 cm (longest diameter) prior to biopsy and \>0.7 cm to ≤2.0 cm after biopsy, located in either the Head...
- Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
- Adequate hepatic, renal and bone marrow functions, as described in the protocol Key
You likely can't join if
- Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid carcinoma, basal cell carcinoma...
- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments...
- History of non-infectious pneumonitis within the last 5 years
- TL (lesion planned for intralesional therapy) or other non-target CSCC lesion in dry red lip (vermillion), oral cavity, or nasal mucosa NOTE: Other...
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Tucson, Arizona, United States
- North Little Rock, Arkansas, United States
- La Jolla, California, United States
- Oceanside, California, United States
- Redwood City, California, United States
- Visalia, California, United States
- Washington D.C., District of Columbia, United States
- Coral Springs, Florida, United States
- Delray Beach, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Naperville, Illinois, United States
- Rockville, Maryland, United States
- Beverly, Massachusetts, United States
- Boston, Massachusetts, United States
- Midland, Michigan, United States
- Troy, Michigan, United States
- Lee's Summit, Missouri, United States
+ 29 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Tucson, Arizona, United States; North Little Rock, Arkansas, United States; La Jolla, California, United States; Oceanside, California, United States and 43 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.