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

Sponsor
Hoffmann-La Roche
Study ID
NCT05009069
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 18, 2022
Status verified
Apr 2026
Primary completion
Nov 21, 2023
Completion
Nov 10, 2026

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Tiragolumab
    Weeks 1-5: Radiotherapy to the pelvis on Days 1-5 every week. Chemotherapy: Capecitabine or fluorouracil (5-FU) 5 days/week during radiotherapy. Day 1 of Weeks 8, 11 and 14: Atezolizumab plus tiragolumab (Day 1 of each 21-day cycle for 3 cycles).
  • Other: Atezolizumab
    Weeks 1-5: Radiotherapy to the pelvis on Days 1-5 every week. Chemotherapy: Capecitabine or fluorouracil (5-FU) 5 days/week during radiotherapy. Day 1 of Weeks 8, 11 and 14: Atezolizumab (Day 1 of each 21-day cycle for 3 cycles).

Primary Outcome Measure

Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: At Week 16, Day 1 ]

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