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Study was closed early as the sponsor decided not to continue development of certain treatment combinations.
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This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced gastric carcinoma (GC) or gastroesophageal junction carcinoma (GEJC). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population. Cohort 1 will enroll participants with inoperable locally advanced, metastatic, or advanced GC or GEJC, with adenocarcinoma confirmed as the predominant histology, who have not received prior systemic therapy for advanced or metastatic disease. Eligible participants will initially be randomly assigned to one of treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezo + CAPOX (capecitabine + oxaliplatin) | Active Comparator | Participants in the atezolizumab plus capecitabine plus oxaliplatin in Stage 1 will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
|
| Atezo + CAPOX +Tira | Experimental | Participants in the atezolizumab plus capecitabine plus oxaliplatin plus tiragolumab arm in Stage 1 will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab is administered by IV infusion on Day 1 of each 21 day cycle. Treatment until progressive disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions, ≥ 4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off. | Up to 42.1 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) After Randomization | PFS after randomization was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was censored at the day of the last tumor assessment for participants who did not die or did not have documented PD. Median PFS was estimated using the Kaplan-Meier (K-M) method. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With AEs in Stage 2 | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. |
Inclusion Criteria for Stage 1:
Exclusion Criteria for Stage 1:
Exclusion Criteria for Tiragolumab-Containing Arm:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The General Hospital of People?s Liberation Army (301 Hospital) | Beijing | 100853 | China | |||
| the First Hospital of Jilin University |
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
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Participants in Stage 1 were randomized to receive either atezolizumab (atezo) in combination with capecitabine and oxaliplatin (CAPOX) (control arm), or atezolizumab in combination with CAPOX and tiragolumab (tira) (experimental arm). As pre-specified in the Protocol, the sponsor decided not to open the Stage 2 part of the study for enrollment.
A total of 40 participants with inoperable locally advanced, metastatic, or advanced gastric carcinoma (GC) or gastroesophageal junction carcinoma (GEJC), who had not received prior systemic therapy for advanced or metastatic disease, took part in the study at 11 investigative sites in China from 01 March 2022 to 04 September 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezo + CAPOX | Participants received atezolizumab, 1200 milligrams (mg), intravenously (IV) on Day 1 of each cycle, followed by capecitabine, 1000 milligrams per square meter (mg/m^2), orally (PO), twice daily (BID), on Days 1-14 of each cycle, and oxaliplatin 130 mg/m^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (1 Cycle=21 days). After completing Stage 1, participants entered the long-term survival follow-up (LTSFU). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 1, 2023 |
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|
| Capecitabine | Drug | Capecitabine is administered orally twice daily on Days 1-14 of each 21 day cycle. Treatment for up to six cycles. |
|
| Oxaliplatin | Drug | Oxaliplatin is administered by IV infusion on Day 1 of each 21 day cycle. Treatment for up to six cycles. |
|
| Tiragolumab | Drug | Tiragolumab is administered by IV infusion on Day 1 of each 21 day cycle. |
|
| From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to 42.1 months) |
| Overall Survival (OS) After Randomization | OS was defined as the time from randomization to death from any cause, regardless of stage. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. Median OS was estimated using the K-M method. | From randomization to death from any cause (up to 42.1 months) |
| OS Rates at Specified Timepoints | OS was defined as the time from randomization to death from any cause, regardless of stage. OS rate at 6 and 12 months was defined as the percentage of participants who did not experience death from any cause at these timepoints from randomization. OS rates at the specified timepoints were estimated using the K-M method. Percentages have been rounded off. | At Months 6 and 12 |
| Duration of Response (DOR) | DOR was defined as time from the first occurrence of a documented objective response (OR), CR or PR to PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target/non-target lesions) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. DOR was censored at the day of the last tumor assessment for participants who did not die or did not have documented PD. Median DOR was estimated using the K-M method. | From first occurrence of CR or PR to PD or death from any cause, whichever occurred first (up to 42.1 months) |
| Disease Control Rate (DCR) | DCR was defined as percentage of participants with stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Percentages have been rounded off. | Up to 42.1 months |
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Up to 42.1 months |
| Up to 42.1 months |
| Changchun |
| 130021 |
| China |
| First Affiliated Hospital of Gannan Medical University | Ganzhou | 341000 | China |
| The First Affiliated Hospital, Zhejiang University | Hangzhou | 310003 | China |
| Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University | Hangzhou | 310016 | China |
| The Second Affiliated Hospital of Anhui Medical University | Hefei | 230601 | China |
| Affiliated Hopsital of Jining Medical University | Jining | 272000 | China |
| Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School | Nanjing | 210008 | China |
| Nan Tong Tumor Hospital | Nantong | 226361 | China |
| Shanxi Province Cancer Hospital | Taiyuan | 030013 | China |
| The First Affiliated Hospital of Xian Jiao Tong University | Xi'an | 710061 | China |
| FG001 | Atezo + CAPOX + Tira | Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU. |
| COMPLETED | Completed Stage 1 and Continued Into Long-term Survival Follow-up Period |
|
| NOT COMPLETED |
|
|
| Long-term Survival Follow-up |
|
|
All Randomized Population included randomized participants, grouped according to the treatment assigned.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezo + CAPOX | Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU. |
| BG001 | Atezo + CAPOX + Tira | Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions, ≥ 4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to < 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off. | Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 42.1 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) After Randomization | PFS after randomization was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was censored at the day of the last tumor assessment for participants who did not die or did not have documented PD. Median PFS was estimated using the Kaplan-Meier (K-M) method. | Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. | Posted | Median | 95% Confidence Interval | months | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to 42.1 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) After Randomization | OS was defined as the time from randomization to death from any cause, regardless of stage. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. Median OS was estimated using the K-M method. | Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. | Posted | Median | 95% Confidence Interval | months | From randomization to death from any cause (up to 42.1 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | OS Rates at Specified Timepoints | OS was defined as the time from randomization to death from any cause, regardless of stage. OS rate at 6 and 12 months was defined as the percentage of participants who did not experience death from any cause at these timepoints from randomization. OS rates at the specified timepoints were estimated using the K-M method. Percentages have been rounded off. | Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. | Posted | Number | 95% Confidence Interval | percentage of participants | At Months 6 and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) | DOR was defined as time from the first occurrence of a documented objective response (OR), CR or PR to PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target/non-target lesions) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. DOR was censored at the day of the last tumor assessment for participants who did not die or did not have documented PD. Median DOR was estimated using the K-M method. | Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed is the number of participants with OR (CR/PR). | Posted | Median | 95% Confidence Interval | months | From first occurrence of CR or PR to PD or death from any cause, whichever occurred first (up to 42.1 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) | DCR was defined as percentage of participants with stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Percentages have been rounded off. | Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 42.1 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Safety-evaluable (SE) population included all participants who received any amount of the study treatment. | Posted | Count of Participants | Participants | Up to 42.1 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With AEs in Stage 2 | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Not Posted | Up to 42.1 months | Participants |
Up to 42.1 months
SE population included all participants who received any amount of the study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atezo + CAPOX | Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU. | 13 | 18 | 9 | 18 | 18 | 18 |
| EG001 | Atezo + CAPOX + Tira | Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU. | 18 | 22 | 12 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Immune-mediated myocarditis | Cardiac disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Lymphocytic hypophysitis | Endocrine disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Gastrointestinal obstruction | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Aortic dilatation | Vascular disorders | MedDRA version: 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version: 28.0 | Systematic Assessment |
| |
| Acid base balance abnormal | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Alpha hydroxybutyrate dehydrogenase increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Blood corticotrophin decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Blood follicle stimulating hormone increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Blood luteinising hormone decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Blood prolactin increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Cortisol decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Electrocardiogram T wave abnormal | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Thyroxine free increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Tri-iodothyronine free increased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA version: 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Pharyngeal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version: 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Pelvic fluid collection | Reproductive system and breast disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version: 28.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA version: 28.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Apr 13, 2026 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| C000730814 | Tiragolumab |
| ID | Term |
|---|---|
| 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 |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Withdrawal by Subject |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
|
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|
|
| OG001 | Atezo + CAPOX + Tira | Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU. |
|
|
| Atezo + CAPOX + Tira |
Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU. |
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