Not provided
Not provided
Not provided
Not provided
Not provided
Sponsor's decision to terminate the study after Stage 1; will not proceed with Stage 2.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment in participants with HER2-negative unresectable advanced, recurrent or metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ AC).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezo + Tira + XELOX | Experimental | Atezolizumab plus tiragolumab in combination with XELOX (oxaliplatin and capecitabine) will be administered during Cycles 1-4 (each cycle is 21 days). During Cycle 5 and beyond atezolizumab and tiragolumab will be administered on Day 1 of each 21-day cycle. Participants will receive study treatment until disease progression, unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab 1200 mg will be administered intravenously (IV) on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) in the Full Analysis Set (FAS) Population | Up to approximately 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) in Responders of the FAS Population | The time from the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months | |
| Progression-free Survival (PFS) in the FAS Population |
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 |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | 100142 | China | |||
| Jilin Cancer Hospital |
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tiragolumab | Drug | Tiragolumab 600 mg will be administered IV on Day 1 of each 21-day cycle. |
|
| Oxaliplatin | Drug | Oxaliplatin 130 mg/m^2 will be administered IV on Day 1 of each 21-day cycle during Cycles 1-4. |
|
| Capecitabine | Drug | Capecitabine 1000 mg/m^2/d will be administered orally (PO) twice daily (bid) on Days 1-14 during Cycles 1-4. |
|
| The time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months |
| Overall Survival (OS) in the FAS Population | The time from initiation of study treatment to death due to any cause up to approximately 20 months |
| Mean Score in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in the FAS Population | Up to approximately 20 months |
| Change from Baseline in EORTC QLQ-C30 in the FAS Population | Up to approximately 20 months |
| Mean Score in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire in Gastric Cancer (EORTC QLQ-STO22) in the FAS Population | Up to approximately 20 months |
| Change from Baseline in EORTC QLQ-STO22 in the FAS Population | Up to approximately 20 months |
| ORR in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression | Up to approximately 20 months |
| Duration of Response (DOR) in Responders of a Subgroup Population With PD-L1 and/or TIGIT Positive Expression | The time from the first occurrence of a confirmed objective response to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months |
| Progression-free Survival (PFS) in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression | The time from initiation of study treatment to the first occurrence of disease progression or death from any cause (whichever occurs first) up to approximately 20 months |
| Overall Survival (OS) in a Subgroup Population With PD-L1 and/or TIGIT Positive Expression | The time from initiation of study treatment to death due to any cause up to approximately 20 months |
| Number of Participants With Adverse Events | Up to approximately 20 months |
| Changchun |
| 132013 |
| China |
| Hunan Cancer Hospital | Changsha | 410013 | China |
| Changzhou First People's Hospital | Changzhou | 213003 | China |
| The First Affiliated Hospital of College of Medicine, Zhejiang University; Medical Oncology | Hangzhou | 310003 | China |
| The First Affiliated Hospital of Anhui Medical University | Hefei | 230022 | China |
| Anhui Province Cancer Hospital | Hefei | 230031 | China |
| Liaoning cancer Hospital & Institute | Shenyang | 110042 | China |
| Tianjin Cancer Hospital | Tianjin | 300060 | China |
| Hubei Cancer Hospital | Wuhan | 430079 | China |
| The First Affiliated Hospital of Xiamen University | Xiamen | 361003 | China |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000730814 | Tiragolumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided