drugset / Trial / NCT05009069
A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will evaluate the efficacy and safety of atezolizumab plus tiragolumab or atezolizumab alone following neoadjuvant chemoradiotherapy (nCRT) in participants with locally advanced rectal cancer (LARC). The study consists of a safety run-in phase and a randomization phase. Participants enrolled in the safety run-in phase will receive atezolizumab + tiragolumab following nCRT. Upon determination of the safety of the treatment regimen, the study will be proceed to the randomization phase. Participants will be randomized in a 1:1 ratio to the atezolizumab + tiragolumab arm or atezolizumab arm.
Timeline
- Start
- 2022-03-18
- Primary completion
- 2023-11-21
- Completion
- 2026-11-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Tiragolumab | Monoclonal antibody | 600 mg | Intravenous |
| Background | Capecitabine | Small molecule | 825 mg/m2 | Oral |
| Background | fluorouracil | Small molecule | 225 mg/m2 | Intravenous |