A Phase 2 interventional study of Atezolizumab and Tiragolumab in Squamous Cell Carcinoma of Head and Neck, sponsored by Hoffmann-La Roche. Completed at 47 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's enrollment of 123 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
Drug: Atezolizumab · Drug: Tiragolumab
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
Drug: Atezolizumab · Drug: Placebo
Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Also known as: Tecentriq, RO5541267
Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Also known as: RO7092284
Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
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.
Time frame: Up to approximately 30.6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From study start up to 90 days after last dose (up to approximately 52.9 months)
Serum Concentration of Atezolizumab at Specified Timepoints
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: Up to approximately 49.9 months
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.
| Milestone | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| Started | 41 | 82 |
| Safety-evaluable (se) population | 39 | 80 |
| Completed | 0 | 0 |
| Not completed | 41 | 82 |
| Withdrew: Death | 28 | 60 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Study ended by sponsor | 10 | 11 |
| Withdrew: Withdrawal by subject | 2 | 9 |
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.
| percentage of participants | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| 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) | 15.4 (6.41 to 31.21) | 21.3 (13.21 to 32.11) |
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.
| months | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| Duration of Response (DOR) | NA (6.28 to NA) | 14.75 (9.69 to NA) |
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.
| months | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| Progression-free Survival (PFS) | 2.99 (1.48 to 7.13) | 4.14 (2.86 to 7.00) |
OS was defined as the time from randomization to death from any cause. K-M method was used to estimate the median OS.
| months | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| Overall Survival (OS) | 13.57 (8.84 to 18.92) | 16.23 (12.68 to 19.88) |
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.
| percentage of participants | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| PFS Rate at 6 Months | 35.90 (20.84 to 50.95) | 42.10 (31.07 to 53.12) |
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.
| percentage of participants | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| Month 6 | 76.92 (63.70 to 90.15) | 83.37 (75.11 to 91.63) |
| Month 12 | 53.05 (37.21 to 68.89) | 64.84 (54.14 to 75.55) |
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.
| months | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| 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 | 9.00 (3.84 to NA) | 11.76 (6.24 to NA) |
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.
| Participants | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 30 | 76 |
| micrograms per milliliter (µg/mL) | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| Pre-dose, Day 1 of Cycle 1 | NA ± NA | NA ± NA |
| 30 minutes post-dose, Day 1 of Cycle 1 | 262 ± 340.5 | 285 ± 296.9 |
| Pre-dose, Day 1 of Cycle 2 | 80.4 ± 40.5 | 84.3 ± 44.0 |
| Pre-dose, Day 1 of Cycle 3 | 118 ± 37.0 | 132 ± 41.5 |
| Pre-dose, Day 1 of Cycle 4 | 131 ± 44.7 | 164 ± 41.3 |
| Pre-dose, Day 1 of Cycle 8 | 197 ± 41.3 | 186 ± 63.2 |
| Pre-dose, Day 1 of Cycle 12 | 218 ± 38.9 | 215 ± 59.7 |
| Pre-dose, Day 1 of Cycle 16 | 170 ± 21.4 | 284 ± 46.4 |
| Treatment Completion/ED | 82.8 ± 105.3 | 137 ± 58.9 |
| µg/mL | Tira + Atezo |
|---|---|
| Pre-dose, Day 1 of Cycle 1 | NA ± NA |
| 30 minutes post-dose, Day 1 of Cycle 1 | 147 ± 863.7 |
| Pre-dose, Day 1 of Cycle 2 | 44.6 ± 45.9 |
| Pre-dose, Day 1 of Cycle 3 | 65.7 ± 46.9 |
| Pre-dose, Day 1 of Cycle 4 | 80.2 ± 45.5 |
| Pre-dose, Day 1 of Cycle 8 | 89.8 ± 77.8 |
| Pre-dose, Day 1 of Cycle 12 | 104 ± 49.6 |
| Pre-dose, Day 1 of Cycle 16 | 124 ± 40.5 |
| Treatment Completion/ED | 67.5 ± 53.6 |
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).
| Participants | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab | 8 | 11 |
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).
| Participants | Tira + Atezo |
|---|---|
| Number of Participants With ADAs to Tiragolumab | 0 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pbo + Atezo | 28/39 (71.8%) | 14/39 (35.9%) | 28/39 (71.8%) |
| Tira + Atezo | 62/80 (77.5%) | 23/80 (28.8%) | 68/80 (85%) |
| Event | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/39 | 0/80 |
| Shock haemorrhagicVascular disorders | 2/39 | 0/80 |
| PneumoniaInfections and infestations | 1/39 | 3/80 |
| Gastrointestinal perforationGastrointestinal disorders | 1/39 | 0/80 |
| Large intestine perforationGastrointestinal disorders | 1/39 | 0/80 |
| AstheniaGeneral disorders | 1/39 | 0/80 |
| DeathGeneral disorders | 1/39 | 2/80 |
| Device related thrombosisGeneral disorders | 1/39 | 0/80 |
| General physical health deteriorationGeneral disorders | 1/39 | 0/80 |
| PyrexiaGeneral disorders | 1/39 | 0/80 |
| Event | Pbo + Atezo | Tira + Atezo |
|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 2/39 | 19/80 |
| ConstipationGastrointestinal disorders | 8/39 | 9/80 |
| HypothyroidismEndocrine disorders | 6/39 | 15/80 |
| AstheniaGeneral disorders | 7/39 | 10/80 |
| Decreased appetiteMetabolism and nutrition disorders | 6/39 | 12/80 |
| FatigueGeneral disorders | 5/39 | 11/80 |
| NauseaGastrointestinal disorders | 5/39 | 8/80 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 5/39 | 7/80 |
| AnaemiaBlood and lymphatic system disorders | 4/39 | 10/80 |
| CoughRespiratory, thoracic and mediastinal disorders | 4/39 | 10/80 |
Intent-to-treat (ITT) population included all randomized participants irrespective of whether the assigned treatment was actually received.
| Age, Continuous(years) | Pbo + Atezo | Tira + Atezo | Total |
|---|---|---|---|
| Mean | 63.7 ± 10.0 | 64.6 ± 10.3 | 64.3 ± 10.2 |
| Sex: Female, Male(Participants) | Pbo + Atezo | Tira + Atezo | Total |
|---|---|---|---|
| Female | 11 | 17 | 28 |
| Male | 30 | 65 | 95 |
| Ethnicity (NIH/OMB)(Participants) | Pbo + Atezo | Tira + Atezo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 3 | 3 |
| Not Hispanic or Latino | 29 | 60 | 89 |
| Unknown or Not Reported | 12 | 19 | 31 |
| Race (NIH/OMB)(Participants) | Pbo + Atezo | Tira + Atezo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 8 | 19 | 27 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 0 | 0 | 0 |
| White | 20 | 43 | 63 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 12 | 20 | 32 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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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Squamous Cell Carcinoma of Head and Neck→
Hoffmann-La Roche