Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003708-33 | EudraCT Number |
Not provided
Not provided
Global desprioritization decision by the sponsor.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab | Experimental | 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). |
|
| Atezolizumab + Tiragolumab | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival (DFS) Rate at 24 Months | Month 24 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall dHebron; Oncology | Barcelona | BARCELONA | 08035 | Spain | ||
| Hospital Universitario 12 de Octubre; Servicio de Oncologia |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
|
| Up to approximately 60 months |
| Madrid |
| Madrid |
| 28041 |
| Spain |
| Hospital Universitario Virgen; Servicio de Oncologia | Seville | SEVILLA | 41013 | Spain |
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000730814 | Tiragolumab |
Not provided
Not provided
Not provided