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)

Sponsor
Hoffmann-La Roche
Study ID
NCT06331598
Phase
PHASE2
Status
Withdrawn

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 30, 2024
Status verified
Dec 2024
Primary completion
Oct 20, 2028
Completion
Sep 20, 2029

Study Design

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

Arms

  • Experimental: Atezolizumab
    Participants will be treated with atezolizumab every 4 weeks (Q4W) for 12 cycles (cycle = 28 days). After study treatment discontinuation participants will be followed until disease progression and afterwards, survival follow-up and new anti-cancer therapy will be collected until death (unless the participant withdraws consent, is lost to follow-up or the Sponsor terminates the study).
  • Experimental: Atezolizumab + Tiragolumab
    Participants will be treated with atezolizumab and tiragolumab Q4W for 12 cycles (cycle = 28 days). After study treatment discontinuation participants will be followed until disease progression and afterwards, information on survival follow-up and new anti-cancer therapy will be collected until death (unless the participant withdraws consent, is lost to follow-up or the Sponsor terminates the study).

Primary Outcome Measure

Disease Free Survival (DFS) Rate at 24 Months [ Time Frame: Month 24 ]

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