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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002852-19 | EudraCT Number |
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The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Tiragolumab | Experimental | Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle. |
|
| Atezolizumab + Placebo | Placebo Comparator | Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed Objective Response, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | A confirmed objective response rate (ORR) was defined as the percentage of participants with a confirmed objective response (OR), characterized by a complete response (CR) or a partial response (PR), on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator per RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) 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. Percentages have been rounded off. | Up to approximately 30.6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DOR) | DOR was defined as the time from the first occurrence of a documented confirmed OR to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. Confirmed OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Kaplan-Meier (K-M) method was used to estimate the median DOR. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moores Cancer Center at UC San Diego Health | La Jolla | California | 92093 | United States | ||
| UCLA |
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 were randomized in a 2:1 ratio to receive either tiragolumab + atezolizumab (Tira + Atezo) or placebo + atezolizumab (Pbo + Atezo). The study is considered "Completed" because all the pre-planned study activities and analyses have been performed.
A total of 123 participants diagnosed with recurrent/metastatic programmed death-ligand 1 (PD-L1) positive squamous cell carcinoma of the head and neck (SCCHN) took part in the study at 57 investigative sites across 13 countries from 02 March 2021 to 27 August 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pbo + Atezo | Participants received atezolizumab, 1200 milligrams (mg) as intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle, followed by placebo also administered as IV infusion, Q3W on Day 1 of each 21-day cycle until disease progression (PD), unacceptable toxicity or loss of clinical benefit. |
| FG001 |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2023 |
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| Tiragolumab | Drug | Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
|
|
| Placebo | Drug | Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
|
| From first occurrence of a documented confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 30.6 months) |
| Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the median PFS. | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 30.6 months) |
| Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate the median OS. | From randomization to death from any cause (up to approximately 30.6 months) |
| PFS Rate at 6 Months | PFS rate at 6 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at Month 6. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the PFS rate. Percentages have been rounded off. | Month 6 |
| OS Rate at 6 Months and 12 Months | OS rate at 6 months and 12 months was defined as percentage of participants who did not experience death from any cause at the specified timepoints. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off. | Months 6 and 12 |
| Time to Confirmed Deterioration (TTCD) in Participant-reported Physical Functioning (PF), as Measured by the Patient-reported Outcomes Measurement Information System (PROMIS) Item Bank Version 2.0 (v2.0)-PF-Short Form 10b | TTCD=time from the date of randomization to the first confirmed clinically meaningful deterioration (CCMD). PROMIS Item Bank v2.0-PF- Short Form 10b is a 10-item participant-reported questionnaire including 2 types of items to assess PF: 6 ability-based items assessing difficulty in performing activities, scored on a 5-point scale ranging from 1=Unable to do, 2=With much difficulty, 3=With some difficulty, 4=With a little difficulty, 5=Without any difficulty; and 4 limitation-based items assessing the extent to which health limits activities, scored on a 5-point scale ranging from 1=Cannot do, 2=Quite a lot, 3=Somewhat, 4=Very little, 5=Not at all. Item responses were summed to generate a raw score and converted to a PROMIS T-score, with a higher T-score indicating better PF. CCMD=decrease from baseline (≥ 4 points) in T-score, held for at least 2 consecutive assessments. K-M method was used to estimate median TTCD. | Up to approximately 30.6 months |
| Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any of the following: 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. | From study start up to 90 days after last dose (up to approximately 52.9 months) |
| Serum Concentration of Atezolizumab at Specified Timepoints | Pre-dose and 30 minutes post-dose on Day 1 of Cycle 1; Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, & 16; and at treatment completion/early discontinuation (ED) (1 Cycle=21 days) (up to approximately 49.9 months) |
| Serum Concentration of Tiragolumab at Specified Timepoints | Pre-dose and 30 minutes post-dose on Day 1 of Cycle 1; Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, & 16; and at treatment completion/ED (1 Cycle=21 days) (up to approximately 49.9 months) |
| Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following atezolizumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). | Up to approximately 49.9 months |
| Number of Participants With ADAs to Tiragolumab | Participants were considered to be ADA positive if they were ADA negative 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 greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). | Up to approximately 49.9 months |
| Los Angeles |
| California |
| 90095 |
| United States |
| SCRI Florida Cancer Specialists PAN | Tallahassee | Florida | 32308 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| Tennessee Oncology - Nashville | Nashville | Tennessee | 37203 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| CHU Bordeaux | Bordeaux | 33075 | France |
| Centre Francois Baclesse | Caen | 14076 | France |
| Centre Leon Berard | Lyon | 69373 | France |
| Institut régional du Cancer Montpellier | Montpellier | 34298 | France |
| Institut Curie | Paris | 75231 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Anticancer Hospital Ag Savas | Athens | 115 22 | Greece |
| Attiko Hospital University of Athens | Athens | 12462 | Greece |
| Periph. University General Hospital of Heraklion Crete | Heraklion | 711 10 | Greece |
| Euromedical General Clinic of Thessaloniki | Thessaloniki | 546 45 | Greece |
| Gy?r-Moson-Sopron Vármegyei Petz Aladár Egyetemi Oktató Kórház | Gy?r | 9024 | Hungary |
| Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont | Kecskemét | 6000 | Hungary |
| Pécsi Tudományegyetem | Pécs | 7623 | Hungary |
| Asst Degli Spedali Civili Di Brescia | Brescia | Lombardy | 25100 | Italy |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | 20133 | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Tuscany | 50134 | Italy |
| Auckland City Hospital, Cancer and Blood Research | Auckland | 1023 | New Zealand |
| Beskidzkie Centrum Onkologii- Szpital Miejski | Bielsko-Biala | 43-300 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gda?sk | 80-214 | Poland |
| Centrum Terapii Wspolczesnej J.M.Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | 90-242 | Poland |
| Centrum Onkologii Ziemi Lubelskiej Im. ?W. Jana Z Dukli | Lublin | 20-090 | Poland |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Institut Catala d Oncologia Hospital Duran i Reynals | Barcelona | 08908 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 112201 | Taiwan |
| National Taiwan University Hospital | Zhongzheng Dist. | 10048 | Taiwan |
| Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| Songklanagarind Hospital | Songkhla | 90110 | Thailand |
| Velindre Cancer Centre | Cardiff | CF14 2TL | United Kingdom |
| Beatson West of Scotland Cancer Centre | Glasgow | G12 0YN | United Kingdom |
| Guys and St Thomas NHS Foundation Trust, Guys Hospital | London | SE1 9RT | United Kingdom |
| Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| Tira + Atezo |
Participants received atezolizumab, 1200 mg as IV infusion, Q3W on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg also administered as IV infusion, Q3W on Day 1 of each 21-day cycle until PD, unacceptable toxicity or loss of clinical benefit. |
| Safety-evaluable (SE) Population | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all randomized participants irrespective of whether the assigned treatment was actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pbo + Atezo | Participants received atezolizumab, 1200 mg as IV infusion, Q3W on Day 1 of each 21-day cycle, followed by placebo also administered as IV infusion, Q3W on Day 1 of each 21-day cycle until PD, unacceptable toxicity or loss of clinical benefit. |
| BG001 | Tira + Atezo | Participants received atezolizumab, 1200 mg as IV infusion, Q3W on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg also administered as IV infusion, Q3W on Day 1 of each 21-day cycle until PD, unacceptable toxicity or loss of clinical benefit. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Confirmed Objective Response, as Determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | A confirmed objective response rate (ORR) was defined as the percentage of participants with a confirmed objective response (OR), characterized by a complete response (CR) or a partial response (PR), on 2 consecutive occasions ≥ 4 weeks apart, as determined by the investigator per RECIST v1.1. CR was defined as the disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any pathological lymph nodes (whether target or non-target) 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. Percentages have been rounded off. | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 30.6 months |
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| Secondary | Duration of Response (DOR) | DOR was defined as the time from the first occurrence of a documented confirmed OR to PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. Confirmed OR was defined as either a CR or a PR on 2 consecutive occasions ≥ 4 weeks apart. CR was defined as disappearance of all target and non-target lesions & normalization of tumor marker level. Additionally, any lymph nodes (whether target or non-target) 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. Kaplan-Meier (K-M) method was used to estimate the median DOR. | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. Overall number analyzed is the number of participants with a confirmed OR. | Posted | Median | 95% Confidence Interval | months | From first occurrence of a documented confirmed OR to PD or death from any cause, whichever occurred first (up to approximately 30.6 months) |
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| Secondary | Progression-free Survival (PFS) | PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the median PFS. | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. | Posted | Median | 95% Confidence Interval | months | From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to approximately 30.6 months) |
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| Secondary | Overall Survival (OS) | OS was defined as the time from randomization to death from any cause. K-M method was used to estimate the median OS. | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. | Posted | Median | 95% Confidence Interval | months | From randomization to death from any cause (up to approximately 30.6 months) |
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| Secondary | PFS Rate at 6 Months | PFS rate at 6 months was defined as the percentage of participants who did not experience PD or death from any cause, as determined by the investigator, at Month 6. PFS was defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurred first. 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). Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm or unequivocal progression of existing non-target lesions. K-M method was used to estimate the PFS rate. Percentages have been rounded off. | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 6 |
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| Secondary | OS Rate at 6 Months and 12 Months | OS rate at 6 months and 12 months was defined as percentage of participants who did not experience death from any cause at the specified timepoints. OS was defined as the time from randomization to death from any cause. K-M method was used to estimate OS rate. Percentages have been rounded off. | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. | Posted | Number | 95% Confidence Interval | percentage of participants | Months 6 and 12 |
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| Secondary | Time to Confirmed Deterioration (TTCD) in Participant-reported Physical Functioning (PF), as Measured by the Patient-reported Outcomes Measurement Information System (PROMIS) Item Bank Version 2.0 (v2.0)-PF-Short Form 10b | TTCD=time from the date of randomization to the first confirmed clinically meaningful deterioration (CCMD). PROMIS Item Bank v2.0-PF- Short Form 10b is a 10-item participant-reported questionnaire including 2 types of items to assess PF: 6 ability-based items assessing difficulty in performing activities, scored on a 5-point scale ranging from 1=Unable to do, 2=With much difficulty, 3=With some difficulty, 4=With a little difficulty, 5=Without any difficulty; and 4 limitation-based items assessing the extent to which health limits activities, scored on a 5-point scale ranging from 1=Cannot do, 2=Quite a lot, 3=Somewhat, 4=Very little, 5=Not at all. Item responses were summed to generate a raw score and converted to a PROMIS T-score, with a higher T-score indicating better PF. CCMD=decrease from baseline (≥ 4 points) in T-score, held for at least 2 consecutive assessments. K-M method was used to estimate median TTCD. | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. | Posted | Median | 95% Confidence Interval | months | Up to approximately 30.6 months |
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| Secondary | Number of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, regardless of causal attribution. An AE was therefore any of the following: 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. | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. | Posted | Count of Participants | Participants | From study start up to 90 days after last dose (up to approximately 52.9 months) |
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| Secondary | Serum Concentration of Atezolizumab at Specified Timepoints | Atezolizumab pharmacokinetic (PK)-evaluable population included all randomized participants who received at least one dose of atezolizumab and had atleast 1 evaluable PK sample. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | Pre-dose and 30 minutes post-dose on Day 1 of Cycle 1; Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, & 16; and at treatment completion/early discontinuation (ED) (1 Cycle=21 days) (up to approximately 49.9 months) |
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| Secondary | Serum Concentration of Tiragolumab at Specified Timepoints | Tiragolumab PK-evaluable population included all randomized participants who received at least one dose of tiragolumab. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Geometric Mean | Geometric Coefficient of Variation | µg/mL | Pre-dose and 30 minutes post-dose on Day 1 of Cycle 1; Pre-dose on Day 1 of Cycles 2, 3, 4, 8, 12, & 16; and at treatment completion/ED (1 Cycle=21 days) (up to approximately 49.9 months) |
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| Secondary | Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | Participants were considered to be ADA positive if they were ADA negative at baseline but developed an ADA response following atezolizumab administration (treatment-induced ADA response), or if they were ADA positive at baseline and the titer of one or more post-baseline samples was greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 titer unit (t.u.) greater than the baseline titer result (treatment-enhanced ADA response). | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to approximately 49.9 months |
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| Secondary | Number of Participants With ADAs to Tiragolumab | Participants were considered to be ADA positive if they were ADA negative 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 greater than the titer of the baseline sample by a scientifically reasonable margin such as at least 0.60 t.u. greater than the baseline titer result (treatment-enhanced ADA response). | SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. Overall number analyzed is the number of participants with data available for analysis. | Posted | Count of Participants | Participants | Up to approximately 49.9 months |
|
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All AEs: From study start up to 90 days after last dose (up to approximately 52.9 months) All-cause mortality: Up to 53.8 months
SE population included all randomized participants who received at least one dose of study treatment, with participants grouped and analyzed based on actual treatment received. 4 participants did not receive any study treatment and were therefore excluded from safety analysis.
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 | Pbo + Atezo | Participants received atezolizumab, 1200 mg as IV infusion, Q3W on Day 1 of each 21-day cycle, followed by placebo also administered as IV infusion, Q3W on Day 1 of each 21-day cycle until PD, unacceptable toxicity or loss of clinical benefit. | 28 | 39 | 14 | 39 | 28 | 39 |
| EG001 | Tira + Atezo | Participants received atezolizumab, 1200 mg as IV infusion, Q3W on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg also administered as IV infusion, Q3W on Day 1 of each 21-day cycle until PD, unacceptable toxicity or loss of clinical benefit. | 62 | 80 | 23 | 80 | 68 | 80 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Gastrointestinal perforation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oesophageal fistula | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Device related thrombosis | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hepatic cytolysis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated hepatic disorder | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Stoma site infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Immune-mediated lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dermatitis psoriasiform | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pemphigoid | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Breath odour | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 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 14, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000730814 | Tiragolumab |
Not provided
Not provided
Not provided
| 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 |
|
| OG001 | Tira + Atezo | Participants received atezolizumab, 1200 mg as IV infusion, Q3W on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg also administered as IV infusion, Q3W on Day 1 of each 21-day cycle until PD, unacceptable toxicity or loss of clinical benefit. |
|
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| Participants |
|
|
|
| OG001 | Tira + Atezo | Participants received atezolizumab, 1200 mg as IV infusion, Q3W on Day 1 of each 21-day cycle, followed by tiragolumab, 600 mg also administered as IV infusion, Q3W on Day 1 of each 21-day cycle until PD, unacceptable toxicity or loss of clinical benefit. |
|
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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