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Withdrawn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

First listed
Mar 26, 2024
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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