NCT05009069

A Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Participants With Locally Advanced Rectal Cancer

A Phase II, Randomized, Open Label, Parallel-group Study of Atezolizumab With or Without Tiragolumab Following Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Rectal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Neoplasms
• Rectal Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Weeks 1-5: 45-50.4Gy in 25-28 fractions to the pelvis on Days 1-5 every week.
DRUG	Capecitabine	Weeks 1-5: Capecitabine 825 mg/m\^2 orally twice daily (bid) 5 days/week during radiotherapy.
DRUG	Fluorouracil	Weeks 1-5: fluorouracil (5-FU) 225 mg/m\^2 intravenously (IV) over 24 hours 5 days/week during radiotherapy.
DRUG	Atezolizumab	Weeks 8, 11 and 14: Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle for 3 cycles.
DRUG	Tiragolumab	Weeks 8, 11 and 14: Tiragolumab 600 mg IV on Day 1 of each 21-day cycle for 3 cycles.

Timeline

• Start date: 2022-03-18
• Primary completion: 2023-11-21
• Completion: 2026-11-06
• First posted: 2021-08-17
• Last updated: 2026-01-22

Locations

5 sites across 1 country: China

Regulatory

• FDA-regulated drug study