A Phase 3 interventional study of Atezolizumab and Placebo in Locally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN), sponsored by Hoffmann-La Roche. Terminated at 135 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This study will evaluate the efficacy and safety of atezolizumab compared with placebo as adjuvant therapy after definitive local therapy in patients with high-risk locally advanced squamous cell carcinoma of the head and neck (SCCHN)
Exclusion Criteria:
Participants will receive Atezolizumab for 16 cycles, or up to 1 year (whichever occurs first)
Drug: Atezolizumab
Participants will receive Placebo for 16 cycles, or up to 1 year (whichever occurs first).
Drug: Placebo
Atezolizumab intravenous infusion will be administered at a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
Placebo intravenous infusion will be administered a fixed dose on Day 1 of each 21-day cycle for 16 cycles.
Investigator-Assessed Event-Free Survival (INV-assessed EFS)
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression \[per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\] per assessment by investigator, or death from any cause, whichever occurred first. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method.
Time frame: Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years)
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.
Time frame: Randomization to death from any cause (up to 5 years, 5 months)
Independent Review Facility (IRF) Assessed EFS
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, 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 on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method.
Time frame: Randomization to the first documented disease recurrence, disease progression or death from any cause, whichever occurs first (up to 5 years)
Percentage of Participants Event-Free for IRF-assessed EFS at 1, 2, 3, and 4 Years
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, 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 on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 \& 4 years.
Time frame: From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years
Percentage of Participants Event-Free for INV-assessed EFS at 1, 2, 3, and 4 Years
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by the investigator, 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 on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 \& 4 years.
Time frame: From randomization to EFS event or date last known to be alive and event-free at 1, 2, 3, and 4 years
Percentage of Participants Event-Free for OS at 2, 3, and 5 Years
OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at 2, 3 and 5 years.
Time frame: From randomization to OS event or date last known to be alive at 2, 3, and 5 Years
Change From Baseline in Physical Function (PF) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire- Core 30 (EORTC-QLQ-C30) Score
EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptoms (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in PF was assessed using the PF scale, where participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) was scored on a 4-point scale (1=Not at All to 4=Very Much). Scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning.
Time frame: Baseline, Day 1 of Cycles 2 to 16 (Cycle length = 21 days); study discontinuation visit (up to 1 year); Follow-up approximately every 3 months until disease recurrence or progression (up to approximately 4.5 years)
Change From Baseline in Health-related Quality of Life (HRQoL) as Assessed by EORTC-QLQ-C30 Score
EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Question 29: GHS; "How would you rate your overall health during the past week?") and QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome.
Time frame: Baseline, Day 1 of Cycles 2 to 16 (Cycle length = 21 days); study discontinuation visit (up to 1 year); Follow-up approximately every 3 months until disease recurrence or progression (up to approximately 4.5 years)
Number of Participants With at Least One Adverse Event (AE)
An AE is untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
Time frame: From first dose of study drug until 90 days after the last dose of study drug (up to 1 year, 3 months)
Serum Concentration of Atezolizumab
Time frame: Predose and 0.5 hours post dose on Cycle 1 Day 1; Predose on Day 1 of Cycles 2, 4, 8, and 16 (Cycle length=21 days); study discontinuation visit (up to 1 year)
Number of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab
Number of participants positive for Treatment Emergent ADA is the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period.
Time frame: Predose on Day 1 of Cycles 1, 2, 4, 8 and 16 (Cycle length=21 days)
Participants took part in the study across 128 investigative sites in 23 countries from 03 April 2018 to 06 March 2024.
| Milestone | Placebo | Atezolizumab |
|---|---|---|
| Started | 203 | 203 |
| Received at least one dose of study drug | 203 | 202 |
| Completed | 0 | 0 |
| Not completed | 203 | 203 |
| Withdrew: Death | 67 | 70 |
| Withdrew: Lost to follow-up | 4 | 2 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Study terminated by sponsor | 120 | 121 |
| Withdrew: Withdrawal by subject | 12 | 9 |
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression \[per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\] per assessment by investigator, or death from any cause, whichever occurred first. Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters (SOD) of target lesions, taking as reference the smallest SOD on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method.
| months | Placebo | Atezolizumab |
|---|---|---|
| Investigator-Assessed Event-Free Survival (INV-assessed EFS) | 52.73 (41.43 to NA) | 59.47 (46.75 to NA) |
OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. OS was estimated using the Kaplan-Meier method.
| months | Placebo | Atezolizumab |
|---|---|---|
| Overall Survival (OS) | NA (NA to NA) | NA (59.47 to NA) |
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, 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 on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. EFS was estimated using the Kaplan-Meier method.
| months | Placebo | Atezolizumab |
|---|---|---|
| Independent Review Facility (IRF) Assessed EFS | 52.73 (43.10 to NA) | 59.47 (45.17 to NA) |
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by IRF, 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 on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 \& 4 years.
| percentage of participants | Placebo | Atezolizumab |
|---|---|---|
| 1 Year | 72.59 (66.41 to 78.77) | 71.92 (65.68 to 78.16) |
| 2 Year | 65.85 (59.25 to 72.46) | 66.31 (59.73 to 72.89) |
| 3 Year | 59.87 (52.99 to 66.76) | 61.07 (54.25 to 67.88) |
| 4 Year | 54.71 (47.51 to 61.90) | 54.72 (47.52 to 61.91) |
EFS was defined as the time from randomization to the first documented disease recurrence (per unequivocal radiographic evidence of local recurrence, new second primary SCCHN lesion, or development of distant metastasis), or disease progression (per RECIST v1.1) per assessment by the investigator, 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 on study (including baseline). Participants without disease recurrence, progression or death at the time of analysis were censored at the time of the last tumor assessment. Kaplan-Meier approach was used to estimate percentage of participants who were event-free for EFS at 1, 2, 3 \& 4 years.
| percentage of participants | Placebo | Atezolizumab |
|---|---|---|
| 1 Year | 70.84 (64.58 to 77.10) | 76.01 (70.09 to 81.93) |
| 2 Year | 63.81 (57.17 to 70.45) | 67.41 (60.90 to 73.92) |
| 3 Year | 58.57 (51.73 to 65.41) | 61.71 (54.94 to 68.49) |
| 4 Year | 55.51 (48.49 to 62.52) | 56.82 (49.75 to 63.88) |
OS was defined as the time from randomization to death from any cause. Data from participants who were alive at the time of the analysis was censored as of the last date they were known to be alive. Kaplan-Meier approach was used to estimate the percentage of participants who were event-free for OS at 2, 3 and 5 years.
| percentage of participants | Placebo | Atezolizumab |
|---|---|---|
| 2 Year | 79.23 (73.64 to 84.82) | 82.00 (76.68 to 87.33) |
| 3 Year | 73.59 (67.48 to 79.70) | 72.34 (66.11 to 78.56) |
| 5 Year | 62.00 (53.46 to 70.55) | 60.93 (48.01 to 73.86) |
EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptoms (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in PF was assessed using the PF scale, where participant responses to 5 questions about daily activities (strenuous activities, long walks, short walks, bed/chair rest \& needing help with eating, dressing, washing themselves, or using the toilet) was scored on a 4-point scale (1=Not at All to 4=Very Much). Scores were linearly transformed on a scale of 0 to 100, with a high score indicating worst functioning.
| score on a scale | Placebo | Atezolizumab |
|---|---|---|
| Baseline (Cycle 1 Day 1) | 82.78 ± 16.36 | 83.46 ± 16.79 |
| Change at Cycle 2 Day 1 | 2.40 ± 11.09 | -0.58 ± 10.54 |
| Change at Cycle 3 Day 1 | 3.75 ± 12.03 | -0.13 ± 12.62 |
| Change at Cycle 4 Day 1 | 2.90 ± 13.00 | 0.77 ± 13.42 |
| Change at Cycle 5 Day 1 | 4.69 ± 13.86 | 1.60 ± 12.15 |
| Change at Cycle 6 Day 1 | 4.03 ± 12.76 | 2.18 ± 13.87 |
| Change at Cycle 7 Day 1 | 4.33 ± 13.07 | 3.56 ± 13.68 |
| Change at Cycle 8 Day 1 | 4.63 ± 13.07 | 3.19 ± 13.71 |
| Change at Cycle 9 Day 1 | 4.62 ± 13.86 | 2.96 ± 14.41 |
| Change at Cycle 10 Day 1 | 4.41 ± 14.30 | 2.12 ± 14.22 |
| Change at Cycle 11 Day 1 | 3.82 ± 14.20 | 3.69 ± 12.43 |
| Change at Cycle 12 Day 1 | 4.35 ± 15.23 | 3.05 ± 14.89 |
| Change at Cycle 13 Day 1 | 5.62 ± 13.63 | 3.30 ± 15.02 |
| Change at Cycle 14 Day 1 | 6.73 ± 13.67 | 3.20 ± 13.36 |
| Change at Cycle 15 Day 1 | 6.13 ± 13.11 | 3.99 ± 12.92 |
| Change at Cycle 16 Day 1 | 5.92 ± 14.85 | 4.11 ± 12.88 |
| Change at Study Discontinuation | 2.94 ± 16.52 | 2.70 ± 14.20 |
| Change at Follow Up 1 | 1.47 ± 16.36 | -6.63 ± 24.41 |
| Change at Follow Up 2 | -1.15 ± 18.10 | 0.19 ± 17.34 |
| Change at Follow Up 3 | -0.81 ± 17.17 | 2.68 ± 18.75 |
| Change at Follow Up 4 | -1.90 ± 18.62 | -2.56 ± 28.57 |
| Change at Follow Up 5 | -2.00 ± 26.21 | -6.03 ± 35.58 |
| Change at Follow Up 6 | -3.61 ± 18.08 | -3.24 ± 23.84 |
| Change at Follow Up 7 | -6.75 ± 21.85 | 1.54 ± 24.82 |
| Change at Follow Up 8 | -13.08 ± 28.96 | 1.36 ± 33.11 |
| Change at Follow Up 9 | 2.88 ± 14.38 | 4.63 ± 17.36 |
| Change at Follow Up 10 | -16.43 ± 32.50 | 3.33 ± 13.80 |
| Change at Follow Up 11 | -10.00 ± 35.31 | -16.67 ± 24.65 |
| Change at Follow Up 12 | -6.67 ± 8.43 | 0.00 ± 14.40 |
| Change at Follow Up 13 | -5.71 ± 7.13 | 4.44 ± 10.18 |
| Change at Follow Up 14 | -17.78 ± 42.86 | -6.67 ± 0 |
| Change at Follow Up 15 | -5.00 ± 6.38 | — |
| Change at Follow Up 16 | 2.22 ± 10.18 | — |
| Change at Follow Up 17 | -3.33 ± 4.71 | — |
| Change at Follow Up 18 | 13.33 ± 0 | — |
EORTC QLQ-C30 scale consists of 30 questions that assess participant functioning (physical, emotional, role, cognitive, and social), symptom (fatigue, nausea and vomiting, pain), global health/quality of life (QoL), and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Change in HRQoL was assessed using participant responses to questions regarding Global Health Status (Question 29: GHS; "How would you rate your overall health during the past week?") and QoL (Question 30: QoL; "How would you rate your overall quality of life during the past week?") were scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized. Scores range from 0-100. A higher score indicates a better outcome.
| score on a scale | Placebo | Atezolizumab |
|---|---|---|
| Baseline (Cycle 1 Day 1) | 66.92 ± 21.41 | 67.54 ± 20.79 |
| Change at Cycle 2 Day 1 | 2.99 ± 20.32 | 0.09 ± 18.33 |
| Change at Cycle 3 Day 1 | 4.87 ± 24.02 | 0.49 ± 17.35 |
| Change at Cycle 4 Day 1 | 6.05 ± 21.04 | 1.34 ± 17.33 |
| Change at Cycle 5 Day 1 | 5.29 ± 22.80 | 1.19 ± 18.25 |
| Change at Cycle 6 Day 1 | 4.66 ± 23.81 | 3.17 ± 18.01 |
| Change at Cycle 7 Day 1 | 7.25 ± 21.71 | 4.09 ± 17.47 |
| Change at Cycle 8 Day 1 | 7.58 ± 21.48 | 4.25 ± 19.93 |
| Change at Cycle 9 Day 1 | 6.30 ± 23.20 | 3.00 ± 17.93 |
| Change at Cycle 10 Day 1 | 7.83 ± 22.29 | 3.85 ± 17.12 |
| Change at Cycle 11 Day 1 | 7.65 ± 21.21 | 2.64 ± 17.35 |
| Change at Cycle 12 Day 1 | 7.47 ± 22.52 | 2.60 ± 17.75 |
| Change at Cycle 13 Day 1 | 8.45 ± 21.37 | 2.94 ± 18.41 |
| Change at Cycle 14 Day 1 | 6.91 ± 21.82 | 3.39 ± 17.04 |
| Change at Cycle 15 Day 1 | 7.21 ± 21.58 | 5.27 ± 18.13 |
| Change at Cycle 16 Day 1 | 6.30 ± 22.87 | 6.05 ± 17.83 |
| Change at Study Discontinuation | 3.86 ± 23.64 | 1.55 ± 18.41 |
| Change at Follow Up 1 | 1.50 ± 25.01 | -5.83 ± 25.32 |
| Change at Follow Up 2 | 4.67 ± 21.33 | -0.95 ± 21.73 |
| Change at Follow Up 3 | -1.77 ± 18.84 | 2.53 ± 18.57 |
| Change at Follow Up 4 | 0.74 ± 25.32 | 3.87 ± 22.51 |
| Change at Follow Up 5 | 3.16 ± 23.19 | 4.76 ± 23.36 |
| Change at Follow Up 6 | 6.32 ± 23.11 | 1.85 ± 17.28 |
| Change at Follow Up 7 | 2.45 ± 23.34 | -10.26 ± 23.11 |
| Change at Follow Up 8 | -8.33 ± 32.00 | 2.27 ± 11.84 |
| Change at Follow Up 9 | 3.70 ± 17.24 | -1.85 ± 12.34 |
| Change at Follow Up 10 | -15.00 ± 50.14 | 9.38 ± 9.38 |
| Change at Follow Up 11 | -4.63 ± 50.88 | -4.17 ± 19.84 |
| Change at Follow Up 12 | 20.00 ± 40.23 | -14.58 ± 20.83 |
| Change at Follow Up 13 | 11.11 ± 38.61 | -2.78 ± 12.73 |
| Change at Follow Up 14 | 8.33 ± 11.79 | -16.67 ± 0 |
| Change at Follow Up 15 | 14.58 ± 34.94 | — |
| Change at Follow Up 16 | 2.78 ± 12.73 | — |
| Change at Follow Up 17 | -8.33 ± 11.79 | — |
| Change at Follow Up 18 | 8.33 ± 11.79 | — |
An AE is untoward medical occurrence in participant administered a pharmaceutical product \& regardless of causal relationship with this treatment. An AE can therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with use of investigational product, whether or not considered related to investigational product.
| Participants | Placebo | Atezolizumab |
|---|---|---|
| Number of Participants With at Least One Adverse Event (AE) | 186 | 192 |
| micrograms per milliliters (ug/mL) | Atezolizumab |
|---|---|
| Cycle 1 Day 1: Predose | NA ± NA |
| Cycle 1 Day 1: 0.5 hours Post-dose | 447 ± 27.1 |
| Cycle 2 Day 1: Predose | 99.2 ± 31.1 |
| Cycle 4 Day 1: Predose | 186 ± 64.3 |
| Cycle 8 Day 1: Predose | 238 ± 40.6 |
| Cycle 16 Day 1: Predose | 257 ± 40.3 |
| Study Discontinuation | 178 ± 141.0 |
Number of participants positive for Treatment Emergent ADA is the number of post-baseline evaluable participants determined to have treatment induced ADA or treatment-enhanced ADA during the study period.
| Participants | Atezolizumab |
|---|---|
| Number of Participants With Anti-Drug Antibodies (ADA) to Atezolizumab | 13 |
Collected over For adverse events (AEs): From first dose of study drug until 90 days after the last dose of study drug (up to 1 year, 3 months); For all-cause mortality: from randomization through the end of post-treatment survival follow-up (up to 5 years, 5 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 69/203 (34%) | 32/203 (15.8%) | 144/203 (70.9%) |
| Atezolizumab | 70/202 (34.7%) | 32/202 (15.8%) | 155/202 (76.7%) |
| Event | Placebo | Atezolizumab |
|---|---|---|
| PneumoniaInfections and infestations | 1/203 | 6/202 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/203 | 2/202 |
| DeathGeneral disorders | 1/203 | 2/202 |
| CellulitisInfections and infestations | 2/203 | 0/202 |
| Pneumonia aspirationInfections and infestations | 2/203 | 1/202 |
| Cerebrovascular accidentNervous system disorders | 2/203 | 1/202 |
| Laryngeal oedemaRespiratory, thoracic and mediastinal disorders | 2/203 | 1/202 |
| Myocardial infarctionCardiac disorders | 0/203 | 1/202 |
| Salivary gland fistulaGastrointestinal disorders | 0/203 | 1/202 |
| Implant site painGeneral disorders | 0/203 | 1/202 |
| Event | Placebo | Atezolizumab |
|---|---|---|
| HypothyroidismEndocrine disorders | 34/203 | 54/202 |
| FatigueGeneral disorders | 26/203 | 29/202 |
| DiarrhoeaGastrointestinal disorders | 10/203 | 26/202 |
| PruritusSkin and subcutaneous tissue disorders | 15/203 | 23/202 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 16/203 | 22/202 |
| LymphopeniaBlood and lymphatic system disorders | 22/203 | 8/202 |
| AnaemiaBlood and lymphatic system disorders | 18/203 | 19/202 |
| Dry mouthGastrointestinal disorders | 16/203 | 18/202 |
| CoughRespiratory, thoracic and mediastinal disorders | 12/203 | 17/202 |
| RashSkin and subcutaneous tissue disorders | 17/203 | 13/202 |
Intent-to-Treat (ITT) population included all randomized participants, regardless of whether they received any of the assigned treatment.
| Age, Continuous(years) | Placebo | Atezolizumab | Total |
|---|---|---|---|
| Mean | 57.7 ± 10.1 | 59.4 ± 8.5 | 58.5 ± 9.4 |
| Sex: Female, Male(Participants) | Placebo | Atezolizumab | Total |
|---|---|---|---|
| Female | 29 | 35 | 64 |
| Male | 174 | 168 | 342 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Atezolizumab | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 11 | 24 |
| Not Hispanic or Latino | 181 | 183 | 364 |
| Unknown or Not Reported | 9 | 9 | 18 |
| Race (NIH/OMB)(Participants) | Placebo | Atezolizumab | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 61 | 68 | 129 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 135 | 121 | 256 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 6 | 12 | 18 |
| Human papilloma virus (HPV) Status(Participants) | Placebo | Atezolizumab | Total |
|---|---|---|---|
| Negative | 166 | 168 | 334 |
| Positive | 37 | 35 | 72 |
| Type of Definitive Local Therapy(Participants) | Placebo | Atezolizumab | Total |
|---|---|---|---|
| Primary Surgery | 78 | 79 | 157 |
| No Primary Surgery | 125 | 124 | 249 |
| Response to Definitive Local Therapy(Participants) | Placebo | Atezolizumab | Total |
|---|---|---|---|
| Complete Response (CR) | 170 | 170 | 340 |
| Partial Response (PR) or Stable Disease (SD) | 33 | 33 | 66 |
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