NCT06331598

A Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors with Resectable Disease with Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H)

A Phase II, Open Label, Randomized, Non-Comparative Cohorts Study of Adjuvant Atezolizumab or Atezolizumab Plus Tiragolumab in Solid Tumors with Resectable Disease with Intermediate-High Risk of Recurrence and High Tumor Mutational Burden (TMB-H) or Microsatellite Instability (MSI-H)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to evaluate efficacy parameters (disease free survival \[DFS\] and overall survival \[OS\]) of atezolizumab and atezolizumab in combination with tiragolumab in TMB-H or MSI-H as adjuvant treatment after standard radical intended treatment in participants with intermediate-high risk of recurrence.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Atezolizumab	A dose of 1680 mg atezolizumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.
DRUG	Tiragolumab	A dose of 840 mg tiragolumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.

Timeline

• Start date: 2024-11-30
• Primary completion: 2028-10-20
• Completion: 2029-09-20
• First posted: 2024-03-26
• Last updated: 2024-12-24

Locations

3 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study