Solid Tumors
Conditions
Brief 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.
Interventions
DRUGAtezolizumab
A dose of 1680 mg atezolizumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.
DRUGTiragolumab
A dose of 840 mg tiragolumab will be administered intravenously on Day 1 of each 28-day cycle for a total of 12 cycles.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Any of the following solid tumors considered to be resectable with a curative intent: non-small cell lung cancer, skin melanoma, skin squamous cell carcinoma, urothelial carcinoma, colorectal cancer, gastric cancer, endometrial cancer, cervix cancer, head and neck cancer and any other tumor type with known high TMB (≥ 13 mut/MB) or MSI-H * Participants must undergo standard treatment according to the stage of their disease and investigator´s choice * All participants must be disease free after standard therapy to be included in this study * Having TMB ≥ 13 mut/MB or MSI-H in tumor tissue biopsy obtained prior to starting standard treatment or from surgical specimens and analyzed using F1 CDx * Participants must be at intermediate/high risk of recurrence * Adequate hematologic and organ function * Female participants of childbearing potential and male participants with female partners of childbearing potential must be willing to avoid pregnancy * Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.
Exclusion criteria
* Previous malignancies within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * Prior cancer immunotherapy * Women who are pregnant, lactating, or intending to become pregnant during the study * History of autoimmune disease * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan * Significant cardiovascular disease * Treatment with systemic immunosuppressive medications within 2 weeks prior to inclusion * Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives of the drug, whichever is longer, prior to randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease Free Survival (DFS) Rate at 24 Months | Month 24 |
Secondary
| Measure | Time frame |
|---|---|
| DFS Rate at 36, 48 and 60 Months | Months 36, 48, 60 |
| OS (Overall Survival) | From randomization to death from any cause (up to approximately 60 months) |
| Percentage of Participants With Adverse Events | Up to approximately 60 months |
Countries
Spain
Outcome results
None listed