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RP1 · ARTACUS

Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies

Ensayo de Replimune Group, Inc. en Merkel Cell Carcinoma · Basal Cell Carcinoma · Locally Advanced Cutaneous Squamous Cell Carcinoma · Cancer (del registro, en inglés).

Más ensayos de: Carcinoma de células de Merkel · Cáncer.

Fase

Fase 1/2

Estado

En marcha, sin reclutar

Participantes

69

previstos

Centros

24

Fin del objetivo primario

jul 2029

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en may 2020.

Qué mide

Primary Objective for Patients with Locally Advances CSCC (laCSCC) (del registro, en inglés) (36 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer. The skin cancer is either locally advanced (large tumors in the skin, muscles or nerves) or metastatic (spread to other parts of the body). This study will consist of a 28-day Screening Period, a Treatment Period, and a Follow-up Period. During the Treatment Period, patients will be dosed with RP1 every two weeks for up to 2 years (104 weeks). Tumor measurements will be done approximately every 8 weeks (and additionally if needed) until progressive disease, start of subsequent anticancer therapy, or completion/discontinuation of the study. During the Follow-up Period, patients will visit the clinic at 30, 60, and 100-150 days after their last dose of RP1 for safety and quality of life assessments. Patients will continue follow-up for up to 3 years from the day of the last patient's first dose.

Más ensayos de REPL

Todos los de REPL, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04349436), actualizada en abr 2026.