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,
Single group
Sample collection
Biological/VaccinePBMC collection at baseline, after radiotherapy 8 Gy (gray), at 6 months and at 12 months from inclusion: 6 EDTA tubes of 6 ml of peripheral blood mononuclear cell \[PBMC\] will be sent to the central laboratory (Biomonitoring Platform of Besançon, CHRU de Besançon located at Etablissement Français du Sang) at room temperature within 24 hours via an approved carrier for their processing, storage and immunomonitoring analysis. A sending sheet of the samples will be attached to each single sample. Plasma collection at baseline, after radiotherapy 8 Gy, at 6 months and at 12 months from inclusion: One 6 ml EDTA tube should be frozen in each investigation center for plasma collection. Plasma for circulating tumoral DNA (ctDNA) collection at baseline, at 2, 6 and 12 months from inclusion: two EDTA tube of 4 ml should be frozen in each investigation center for ctDNA collection.
Progression-Free Survival (PFS) rate at 1 year.
PFS rate at 1 year is defined as the number of patients alive without progression at 1 year divided by the overall number of patients evaluable for PFS status at 1 year. A patient is evaluable for PFS status at 1 year if he dies during the 1 year of follow up or if he is alive with a RECIST evaluation available at 1 year.
Objective response rate (ORR)
Addition of complete response (CR) and partial response (PR) rates.
Overall survival (OS)
Delay from the date of inclusion to death from any cause , or the date of the last follow-up, at which point data will be censored
Progression-Free Survival (PFS) median.
Delay from the date of inclusion to the disease progression or death from any cause, whichever occurs first , or the date of the last follow-up, at which point data will be censored
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Centre Hospitalier Universitaire de Besancon
Lead sponsor
National Cancer Institute, France
Collaborator
Novartis
Collaborator
