Phase II Study of Atezolizumab and Tiragolumab Combined With Chemoradiotherapy for Localized Squamous Cell Carcinoma of the Anal Canal

What this Trial Is About

Researchers are evaluating the addition of immunotherapy drugs atezolizumab and tiragolumab to the standard chemoradiotherapy treatment for patients with localized squamous cell carcinoma of the anal canal. This Phase II, single-arm trial aims to improve the rate of clinical complete response, which means disappearance of all tumor lesions without residual disease, at the end of the consolidation treatment phase. The study also explores safety, quality of life, and molecular biomarkers to better understand treatment effects and outcomes. All participants will receive atezolizumab 1200 mg plus tiragolumab 600 mg for two cycles every three weeks alongside six weeks of standard chemoradiotherapy, which includes cisplatin, 5-Fluorouracil, and radiotherapy. After this concurrent phase, patients enter a consolidation phase receiving atezolizumab and tiragolumab for up to 24 weeks. Treatment will stop if the cancer progresses, unacceptable side effects occur, or based on patient or physician decision. Participants will be closely monitored throughout the study with clinical evaluations, biopsies to assess tumor response, and quality of life questionnaires. Researchers will track survival rates, tumor relapse, adverse events, and health-related quality of life over several years. Blood and tumor samples will be collected to study immune markers and genetic features. The total study duration for each participant includes treatment and long-term follow-up of up to five years.

Tiraglolumab Atezolizumab and Chemoradiotherapy in Localized Anal Carcinoma (TIRANUS)