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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Cemiplimab
  Administered per protocol
• Процедура Standard of care
  Primary surgery

Первичные конечные точки

• Event-Free Survival (EFS) as assessed by the investigator [Срок оценки: Up to 1 year]
• EFS as assessed by the investigator [Срок оценки: Up to 3 years]

Вторичные конечные точки (6)

• Composite Complete Response (CCR) for Target Lesion (TL) [Срок оценки: At week 13]
• Non-Target Lesions (NTLs) in the Region of the Target Lesion (ROTL) [Срок оценки: Baseline and at week 13]
• Occurrence of Treatment Emergent Adverse Events (TEAEs) [Срок оценки: Up to 3 years]
• Severity of TEAEs [Срок оценки: Up to 3 years]
• Size of surgical defect [Срок оценки: At week 13]
• Size of biopsy defect [Срок оценки: At week 13]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 47 центров

• 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
• … и ещё 39 центров

Австралия · 5 центров

• The Skin Hospital — Darlinghurst
• Westmead Hospital — Westmead
• Princess Alexandra Hospital — Woolloongabba
• Dermatology Institute of Victoria (DIV) — South Yarra
• Fremantle Dermatology — Fremantle

Идентификаторы

NCT: NCT06585410 · R2810-ONC-2251

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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