Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma.

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

January 4, 2022

Primary Completion Date

November 21, 2024

Study Completion Date

July 5, 2026

Conditions
Squamous Cell Carcinoma of the Anus Stage III
Interventions
BIOLOGICAL

Blood sample collection

"A total of 9 EDTA (ethylenediaminetetraacetic acid) tubes will be collected at each time point to perform:~PBMC collection: 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: One 6 ml EDTA tube should be frozen in each investigation center for plasma collection.~Plasma for circulating tumoral DNA (ctDNA) collection: Two 4 ml EDTA tube should be frozen in each investigation center for ctDNA collection."

PROCEDURE

Biopsy

A tumor biopsy will be performed at 2 months after enrollment.

Trial Locations (10)

21000

Centre georges-François Leclerc, Dijon

25000

Centre Hospitalier Universitaire de Besançon, Besançon

69000

Centre Léon Bérard, Lyon

Hôpital Privé Jean Mermoz, Lyon

75000

Hôpital Saint Louis, Paris

Unknown

Hôpital Franco-Britannique, Levallois-Perret

Hôpital Nord Franche-Comté, Montbéliard

Centre Antoine Lacassagne, Nice

CHU de Poitiers, Poitiers

CHU Robert Debré, Reims

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Boehringer Ingelheim

INDUSTRY

lead

Centre Hospitalier Universitaire de Besancon

OTHER