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Recruiting NCT06585410

Study of Intralesional Cemiplimab in Adult Patients With Early Stage Cutaneous Squamous Cell Carcinoma

Phase III Interventional Cutaneous Squamous Cell Carcinoma (CSCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cemiplimab, Standard of care.
Who it may be relevant to
Registry conditions: Cutaneous Squamous Cell Carcinoma (CSCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3 Randomized Study of Intralesional Cemiplimab Versus Primary Surgery in Participants With Early Stage Cutaneous Squamous Cell Carcinoma (CSCC)

Overview

This study will test a study drug called cemiplimab to see if it can help treat early-stage Cutaneous Squamous Cell Carcinoma (CSCC), a type of skin cancer. Cemiplimab works by helping the immune system to kill cancer cells. It binds to a protein called Programmed cell Death-1 (PD-1) on the surface of certain immune cells. The main purpose of this study is to compare how well cemiplimab works compared to surgery, when injected into the lesion. The study is looking at: * The side effects cemiplimab might cause * How well cemiplimab works compared to surgery

Interventions

  • Drug Cemiplimab
    Administered per protocol
  • Procedure Standard of care
    Primary surgery

Primary outcome measures

  • Event-Free Survival (EFS) as assessed by the investigator [Time frame: Up to 1 year]
  • EFS as assessed by the investigator [Time frame: Up to 3 years]
Secondary outcome measures (6)
  • Composite Complete Response (CCR) for Target Lesion (TL) [Time frame: At week 13]
  • Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL) [Time frame: Baseline and at week 13]
  • Occurrence of Treatment Emergent Adverse Events (TEAEs) [Time frame: Up to 3 years]
  • Severity of TEAEs [Time frame: Up to 3 years]
  • Size of surgical defect [Time frame: At week 13]
  • Size of biopsy defect [Time frame: At week 13]

Eligibility criteria

Inclusion criteria

  • 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) located in either the Head or Neck (HN), hand, or pre-tibial surface, as described in the protocol
  • Participants who are judged to be eligible for surgical resection of their CSCC TL and the method of planned surgical resection would be Micrographically oriented histographic surgery (Mohs) or other surgical method of Complete Margin Assessment (CMA). Participants for whom the planned surgery is surgical excision without margin control are not eligible
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
  • Adequate hepatic, renal and bone marrow functions, as described in the protocol

Exclusion criteria

  • Participant in which the TL is a keratoacanthoma (KA), adenosquamous carcinoma, desmoplastic carcinoma, sarcomatoid carcinoma, basal cell carcinoma, basosquamous carcinoma, Bowen's disease, or CSCC in situ without an invasive component. (Note: For participants with invasive CSCC with a minor basaloid component, the patient may be eligible after discussion with the sponsor medical director.)
  • 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), as described in the protocol
  • 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 protocol defined inclusion / exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 47 centers
  • Medical Dermatology Specialists - Phoenix — Phoenix
  • Mayo Clinic - Arizona — Scottsdale
  • University of Arizona Cancer Center — Tucson
  • Arkansas Research Trials — North Little Rock
  • UC San Diego Moores Cancer Center — La Jolla
  • Profound Research, Dermatology Medical Group - Oceanside — Oceanside
  • Stanford University — Redwood City
  • Peak Dermatology, Aesthetics and Wellness — Visalia
  • … and 39 more centers
Australia · 5 centers
  • The Skin Hospital — Darlinghurst
  • Westmead Hospital — Westmead
  • Princess Alexandra Hospital — Woolloongabba
  • Dermatology Institute of Victoria (DIV) — South Yarra
  • Fremantle Dermatology — Fremantle

Identifiers

NCT: NCT06585410 · R2810-ONC-2251

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗