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
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Among 76 studies in Squamous Cell Carcinoma of Head and Neck with a site in Japan — 25 open to participants now, 38 under way, 10 of them phase 3. Squamous Cell Carcinoma of Head and Neck · Japan.
Among the 76 studies in Squamous Cell Carcinoma of Head and Neck with a site in Japan, this one is the 26th largest by enrollment of the 75 interventional ones that give a count, is one of 4 that started in 2018, is one of 20 in phase 3, and was the 22nd registered.
2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.
Browse Squamous Cell Carcinoma of Head and Neck studies →25 of the 76 studies in Squamous Cell Carcinoma of Head and Neck with a site in Japan are open now. Recruiting first, the newest first:
Astellas Pharma Global Development, Inc. · Sites in Japan, United States
Ages 18+
AbbVie · Sites in Japan, United States, Taiwan
Ages 18+
EMD Serono Research & Development Institute, Inc. · Sites in Japan, United States, Canada and 1 more country
Ages 18+
Johnson & Johnson Enterprise Innovation Inc. · Sites in Japan, United States, France and 1 more country
Ages 18–74
Janssen Research & Development, LLC · Sites in Japan, United States, Australia and 19 more countries
Ages 18+
A study can be open while its sites in Japan have not opened yet or have stopped. Only those recruiting at a site in Japan →
Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
76 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 21 · Phase 3 21
First in 2004; this study’s year is marked. 4 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 406 is above the median of 48 across 1,653 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Median enrollment 248 across the 75 interventional studies, 412 across the 1 observational. Of the 37 that completed or were terminated, 21 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
73 of 76 have an industry lead sponsor. The 10 most frequent:
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 88 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Hoffmann-La Roche has 5 studies filed under Squamous Cell Carcinoma of Head and Neck — fewer than ten, so there is no comparison to draw.
8 of the studies in Squamous Cell Carcinoma of Head and Neck with a site in Japan that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
| NCT06238479Eli Lilly and CompanyA Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors | 2027-03 |
| NCT06465069Eli Lilly and CompanyA Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors | 2027-05 |
| NCT03821935AbbVieStudy to Determine the Safety, Tolerability, Pharmacokinetics and Recommended Phase 2 Dose (RP2D) of Livmoniplimab (ABBV-151) as a Single Agent and in Combination With Budigalimab (ABBV-181) in Participants With Locally Advanced or Metastatic Solid Tumors | 2027-06 |
| NCT05005403AbbVieStudy to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan | 2027-07 |
Add all 8 to your calendar (.ics) → With an account.
Among the 76 studies in Squamous Cell Carcinoma of Head and Neck with a site in Japan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
Showing the first 100 of 135 sites across 23 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Sep 2023, 65 months.
Results were first posted in Oct 2024, 1 year after primary completion.
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Studies of the drug tested here: Atezolizumab
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