Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

June 9, 2022

Primary Completion Date

June 1, 2025

Study Completion Date

November 1, 2026

Conditions
Squamous Cell Anal CarcinomaMetastatic Squamous Cell Carcinoma
Interventions
BIOLOGICAL

Sample collection

"PBMC 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."

Trial Locations (5)

25000

RECRUITING

Centre Hospitalier Universitaire de Besançon, Besançon

69000

WITHDRAWN

Centre Léon Bérard, Lyon

Unknown

RECRUITING

Centre Georges-François Leclerc (CGFL), Dijon

WITHDRAWN

Hôpital Franco-Britannique, Levallois-Perret

RECRUITING

Hôpital Nord Franche Comté, Montbéliard

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

Novartis

INDUSTRY

lead

Centre Hospitalier Universitaire de Besancon

OTHER