A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio

De intervención

Fase

Fase 2

Rango de edad

18 años - No especificado

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

34 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

• Biopsy proven cutaneous squamous cell carcinoma which is locally advanced

• Mixed histology tumors that are predominantly squamous cell carcinoma are eligible
• Locally advanced primary tumor is T3-T4 and/or N+ by AJCC and/or UICC 8th edition clinical criteria
• T3-T4 primary tumor characteristics noted below:

• Non-eyelid tumor \>4 cm in maximum dimension or with bone erosion or invasion, perineural invasion of nerve 0.1 mm or larger, or invasion beyond subcutaneous fat or \>6 mm from granular layer of adjacent normal epidermis
• Eyelid tumor \>2 cm or invading adjacent ocular, orbital or facial structures
• ≥18 years old
• Unresectable or medically inoperable according to local multidisciplinary consensus for reasons such as:

• Tumor or regional lymph node metastases that has recurred despite ≥2 prior surgical procedures, with another curative resection unlikely
• Tumor or nodal disease with significant local invasion that precludes complete resection
• Tumor or nodal disease in anatomically challenging area where surgery may result in significant disfigurement or dysfunction (amputation of nose, ear, eye, digit, limb, etc)
• Medical contraindication to surgery
• Patient refusal of surgery due to anticipate morbidity
• ECOG ≤2
• Adequate bone marrow and metabolic function (by blood tests)

• Total bilirubin ≤1.5 x upper limit of normal
• Aspirate aminotransferase (AST) ≤3 x upper limit of normal
• Alanine aminotransferase (ALT) ≤3 x upper limit of normal
• Alkaline phosphatase ≤2.5 x upper limit of normal
• Serum creatinine ≤1.5 x upper limit of normal or estimated creatinine clearance \>30 mL/min according to Cockcroft-Gault formula
• Hemoglobin \>9 g/dL
• Absolute neutrophil count ≥1.5 x10\^9/L
• Platelet count ≥75 x10\^9/L
• Able to provide informed consent
• Acceptable candidate for curative intent radiotherapy and Cemiplimab immunotherapy, in opinion of radiation and medical oncologist, respectively
• Life expectancy \>18 months

Exclusion Criteria:

• Primary tumor originating on the mucosal (non-hair bearing) lip or nose, anogenital (penis, scrotum, vulva, perianal) area
• Iatrogenic immunosuppression (\>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)
• Women of child bearing potential unwilling or unable to use effective contraception while receiving treatment with cemiplimab and for 4 months thereafter
• Distant metastases
• Clinically significant autoimmune disease that requires iatrogenic immunosuppression

o For example, severe rheumatoid arthritis requiring disease modifying antirheumatic drugs, such as methotrexate
* Current or previous hematopoietic malignancy (leukemia, lymphoma)
* Prior allogeneic transplant of solid organ or bone marrow
* Concurrent malignancies with \>10% risk of metastasis or death within 2 years
* Prior aPD1 immunotherapy or PI3Kδ inhibitor use
* Prior radiotherapy for the cutaneous squamous cell carcinoma requiring treatment
* Other ongoing cancer therapy

o Adjuvant endocrine therapy is permitted for patients with prostate or breast cancer
* Uncontrolled HIV or infectious hepatitis (viral load detectable in patient with known infection)
* Pregnancy or breastfeeding
* Comorbid or diagnostic abnormalities within the last year that would interfere with interpretation of study results

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

No aplica

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Centros de investigación (13)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

13 centros

Equipo y fechas

Patrocinador principal

Memorial Sloan Kettering Cancer Center

Inicio del estudio

6 oct 2022 Real

Finalización primaria

6 oct 2027 Estimado

Finalización del estudio

6 oct 2027 Estimado

Primera publicación

10 oct 2022 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.