Tiraglolumab Atezolizumab and Chemoradiotherapy in Localized Anal Carcinoma (TIRANUS)

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

February 14, 2023

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2028

Conditions
Squamous Cell Carcinoma of the Anal Canal
Interventions
DRUG

Atezolizumab plus Tiraglolumab

All patients receive atezolizumab (1200mg) plus tiragolumab (600 mg) for 2 cycles (Q3W) in concomitance with the 6 weeks of standard scheduled chemoradiotherapy (cisplatin: 60 mg/m² on days 1 and 29; 5-FU: 1000 mg/m² per day on days 1-4 and 29-32; radiotherapy: 1.8 Gy per day / total dose 54 Gy). After the concomitant phase, patients receive atezolizumab and tiragolumab for 6 additional cycles (consolidation phase).

Trial Locations (15)

13005

RECRUITING

Hospital General de Ciudad Real, Ciudad Real

24071

RECRUITING

Complejo Asistencial Universitario de León, León

25198

RECRUITING

Hospital Arnau de Vilanova, Lleida

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

28222

RECRUITING

HU Puerta de Hierro Majadahonda, Majadahonda

45007

RECRUITING

Hospital General Universitario de Toledo, Toledo

46014

RECRUITING

Consorcio Hospital General Universitario de Valencia, Valencia

46026

RECRUITING

Hospital Universitario y Politécnico la Fe de Valencia, Valencia

50009

RECRUITING

Hospital Universitario Miguel Servet, Zaragoza

07120

RECRUITING

Hospital Universitario Son Espases, Palma de Mallorca

08908

RECRUITING

Institut Català d'Oncologia (ICO) Hospitalet, L'Hospitalet de Llobregat

08970

RECRUITING

Hospital Sant Joan Despí, Martorell

08024

RECRUITING

Consorcio Corporación Sanitaria Parc Taulí, Sabadell

RECRUITING

Hospital de la Santa Creu i Sant Pau, Barcelona

RECRUITING

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Grupo Espanol Multidisciplinario del Cancer Digestivo

OTHER