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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001157-23 | EudraCT Number | ||
| 2023-508489-14-00 | Registry Identifier | EU CT |
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The purpose of this study is to assess the safety, pharmacokinetics, and immunogenicity of tiragolumab and atezolizumab intravenous fixed-dose combination (IV FDC) in participants with histologically confirmed PD-L1-selected solid tumors whose disease is locally advanced, recurrent, or metastatic and for whom an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiragolumab and Atezolizumab IV FDC | Experimental | Participants will receive tiragolumab and atezolizumab as an intravenous fixed dose combination (IV FDC) on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiragolumab and Atezolizumab IV FDC | Drug | Intravenous fixed dose combination (IV FDC) of tiragolumab 600 mg and atezolizumab 1200 mg once every 3 weeks (Q3W). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention. | Up to approximately 30.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Tiragolumab at Cycle 1 | day*µg/mL=day-micrograms per milliliter. | Up to Day 21 of Cycle 1 (1 cycle=21 days) |
| Area Under the Serum Concentration Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tiragolumab at Cycle 1 |
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Inclusion Criteria:
Cancer-Specific Inclusion Criteria:
Exclusion Criteria:
Cancer-Specific Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Oncology Associates | Spokane | Washington | 99208 | United States | ||
| Chongqing Sanxia Central Hospital |
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 received a fixed dose combination (FDC) of tiragolumab and atezolizumab. The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
A total of 64 adult participants with histologically-confirmed programmed death-ligand 1 (PD-L1)-selected locally advanced, recurrent, or metastatic solid tumors, took part in the study at 27 investigative sites across 8 countries from 04 May 2023 to 26 December 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab + Tiragolumab FDC | Participants received FDC of tiragolumab , 600 milligrams (mg) and atezolizumab , 1200 mg, as intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (PD) per investigator-assessed Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 14, 2023 | May 21, 2026 |
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| 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
| AUC0-21d of Atezolizumab at Cycle 1 | Up to Day 21 of Cycle 1 (1 cycle=21 days) |
| AUC0-inf of Atezolizumab at Cycle 1 | 30 minutes post-dose Day 1 of Cycle 1 (1 cycle=21 days) |
| Maximum Concentration (Cmax) of Tiragolumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
| Cmax of Atezolizumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
| Minimum Concentration (Cmin) of Tiragolumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
| Cmin of Atezolizumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
| Total Body Clearance (CL) of Tiragolumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
| CL of Atezolizumab at Cycle 1 | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
| Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab | Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. | Up to approximately 14.9 months |
| Number of Participants With ADAs to Atezolizumab | Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. | Up to approximately 14.9 months |
| Chongqing |
| 404000 |
| China |
| General Hospital Pula | Pula | 52000 | Croatia |
| Klinicki bolnicki centar Zagreb | Zagreb | 10000 | Croatia |
| IASO Obstetrics Gynecology Clinic | Marousi | 151 23 | Greece |
| University General Hospital of Patras | Pátrai | 265 00 | Greece |
| St. Luke's Hospital | Thessaloniki | 552 36 | Greece |
| University Hospital Medical Center Bezanijska kosa | Belgrade | 11080 | Serbia |
| Oncology Institute of Vojvodina | Kamenitz | 21204 | Serbia |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | 13605 | South Korea |
| Asan Medical Center - PPDS | Seoul | 05505 | South Korea |
| ICO l?Hospitalet ? Hospital Duran i Reynals | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital del Mar | Barcelona | 08003 | Spain |
| Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON | Barcelona | 8035 | Spain |
| C.H. Regional Reina Sofia - PPDS | Córdoba | 14004 | Spain |
| START MADRID_Hospital Universiario Fundacion Jimenez Diaz | Madrid | 28040 | Spain |
| START Madrid_Hospital Universitario HM Sanchinarro_CIOCC | Madrid | 28050 | Spain |
| Hospital Regional Universitario de Malaga ? Hospital General | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 70457 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| TAIPEI VETERANS GENERAL HOSPITAL, Urology | Taipei | 11217 | Taiwan |
| Namik Kemal University | Alt?nova | 59100 | Turkey (Türkiye) |
| Hacettepe Universitesi Tip Fakultesi Hastanesi | Ankara | 06100 | Turkey (Türkiye) |
| Gazi University Medical Faculty | Ankara | 06500 | Turkey (Türkiye) |
| Memorial Ankara Hastanesi | Ankara | 06520 | Turkey (Türkiye) |
| Memorial Sisli Private Hospital | Istanbul | 34385 | Turkey (Türkiye) |
| Inonu University Faculty of Medicine Turgut Ozal Medical Center | Malatya | 44280 | Turkey (Türkiye) |
| Medical Park Seyhan Hospital | Seyhan | 01060 | Turkey (Türkiye) |
| Safety Analysis Set (SAS) | SAS included all participants who received any amount of study treatment. |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all the enrolled study participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab + Tiragolumab FDC | Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity. |
| Units | Counts |
|---|---|
| Participants |
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| 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a participant or clinical study participant temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention. | SAS included all participants who received any amount of study treatment. | Posted | Count of Participants | Participants | Up to approximately 30.5 months |
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| ||||||||||||||||||||||||||
| Secondary | Area Under the Concentration-time Curve From 0 to 21 Days (AUC0-21d) of Tiragolumab at Cycle 1 | day*µg/mL=day-micrograms per milliliter. | Tiragolumab pharmacokinetic (PK)-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*µg/mL | Up to Day 21 of Cycle 1 (1 cycle=21 days) |
|
| ||||||||||||||||||||||||||
| Secondary | Area Under the Serum Concentration Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tiragolumab at Cycle 1 | Tiragolumab PK-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*µg/mL | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
|
| |||||||||||||||||||||||||||
| Secondary | AUC0-21d of Atezolizumab at Cycle 1 | Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*µg/mL | Up to Day 21 of Cycle 1 (1 cycle=21 days) |
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| |||||||||||||||||||||||||||
| Secondary | AUC0-inf of Atezolizumab at Cycle 1 | Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | day*µg/mL | 30 minutes post-dose Day 1 of Cycle 1 (1 cycle=21 days) |
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| Secondary | Maximum Concentration (Cmax) of Tiragolumab at Cycle 1 | Tiragolumab PK-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL (micrograms per milliliter) | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
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| Secondary | Cmax of Atezolizumab at Cycle 1 | Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
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| Secondary | Minimum Concentration (Cmin) of Tiragolumab at Cycle 1 | Tiragolumab PK-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
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| Secondary | Cmin of Atezolizumab at Cycle 1 | Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
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| Secondary | Total Body Clearance (CL) of Tiragolumab at Cycle 1 | Tiragolumab PK-evaluable set included all participants who received any amount of tiragolumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | liters/day (L/day) | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
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| Secondary | CL of Atezolizumab at Cycle 1 | Atezolizumab PK-evaluable set included all participants who received any amount of atezolizumab and had at least one evaluable post-baseline PK assessment available. Overall number analyzed is the number of participants with data available for analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/day | 30 minutes post-dose on Day 1 of Cycle 1 (1 cycle=21 days) |
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| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab | Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. | SAS included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to approximately 14.9 months |
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| |||||||||||||||||||||||||||
| Secondary | Number of Participants With ADAs to Atezolizumab | Participants were considered to be treatment-emergent ADA positive if they were ADA negative or had missing data at baseline but developed an ADA response following tiragolumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). Participants with a positive post-baseline sample has been reported here. | SAS included all participants who received any amount of study treatment. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to approximately 14.9 months |
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Up to approximately 30.5 months
SAS included all participants who received any amount of study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atezolizumab + Tiragolumab FDC | Participants received FDC of tiragolumab, 600 mg and atezolizumab, 1200 mg, as IV infusion on Day 1 of each 21-day cycle until PD per investigator-assessed RECIST v1.1, or loss of clinical benefit, as assessed by the investigator, or unacceptable toxicity. | 34 | 63 | 23 | 63 | 50 | 63 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Oesophageal ulcer | Gastrointestinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Subileus | Gastrointestinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Death | General disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Swelling | General disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Systemic inflammatory response syndrome | General disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Drug-induced liver injury | Hepatobiliary disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Biliary tract infection | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Cytomegalovirus infection | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Fungaemia | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA version: 28.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA version: 28.1 | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA version: 28.1 | Systematic Assessment |
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| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA version: 28.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA version: 28.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA version: 28.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Cerebral small vessel ischaemic disease | Nervous system disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Demyelination | Nervous system disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Neurotoxicity | Nervous system disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Arterial thrombosis | Vascular disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version: 28.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA version: 28.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA version: 28.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA version: 28.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA version: 28.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version: 28.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version: 28.1 | Systematic Assessment |
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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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 21, 2024 | May 21, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000730814 | Tiragolumab |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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