This study evaluates the feasibility of the combination of radiotherapy, chemotherapies (docetaxel, cisplatin and 5-fluorouracil) and spartalizumab (anti-PD-1 therapy) in patients with metastatic squamous cell anal carcinoma
Male or female, aged ≥18 years,
Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) ≤1,
Histologically proven metastatic or locally advanced recurrent squamous cell carcinoma of anus (SCCA)
Presence of a evaluable lesion on CT-scan/MRI assessed by RECIST v1.1 criteria,
HIV positive patient , CD4 count < 400 cells/mm3 (HIV test mandatory before inclusion)
Diagnosis of additional malignancy within 2 years prior to the inclusion with the exception for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy,
Any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,
Current participation in a study of an investigational agent or in the period of exclusion,
Centre Hospitalier Universitaire de Besancon
Lead sponsor
National Cancer Institute, France
Collaborator
Novartis
Collaborator