Clinical Trials List
Protocol NumberWO40242
NCT Number(ClinicalTrials.gov Identfier)NCT03452137
Completed
2018-03-16 - 2024-12-05
Phase III
Terminated5
ICD-10C44.42
Squamous cell carcinoma of skin of scalp and neck
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) as Adjuvant Therapy After Definitive Local Therapy in Patients With High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck
-
Trial Applicant
-
Sponsor
Hoffmann-La Roche
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- RUEY-LONG HONG Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
- HUAI-CHENG HUANG 無
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Mu-Hsin Chang Division of Hematology & Oncology
- Sheng-Yu Chen Division of Hematology & Oncology
- 朱本元 Division of Otolaryngology
- Tsung-Lun Lee Division of Otolaryngology
- 戴世光 Division of Otolaryngology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 劉奕廷 Division of General Internal Medicine
- Shang-Yin Wu Division of General Surgery
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Ming-Yu Lien Division of Hematology & Oncology
- Tzu-Ting Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Objectives
Primary Efficacy Objective
• To evaluate the efficacy of
atezolizumab compared with placebo
Secondary Efficacy Objectives
• To evaluate the efficacy of
atezolizumab compared with placebo
• To evaluate clinical benefit in
atezolizumab compared with placebo in
terms of impact on HRQoL and
physical functioning
Safety Objective
• To evaluate the safety and tolerability
of atezolizumab
Test Drug
TECENTRIQ (Atezolizumab)
Active Ingredient
atezolizumab
Dosage Form
injection
Dosage
1200mg/20ml
Endpoints
Primary
• IRF-assessed EFS, defined as the time from
randomization to the first documented disease
recurrence (per unequivocal radiographic evidence
of local recurrence, new primary lesion, or
development of distant metastasis), or disease
progression (per RECIST v1.1) or death from any
cause, whichever occurs first
• OS after randomization, defined as the time from
randomization to death from any cause
Secondary
• Investigator-assessed EFS, defined as the time
from randomization to the first documented disease
recurrence (per unequivocal radiographic evidence
of local recurrence, new primary lesion, or
development of distant metastasis), or disease
progression (per RECIST v1.1) or death from any
cause, whichever occurs first
• IRF-assessed EFS and investigator-assessed EFS
at 1 and 2 years
• OS at 1, 2, and 3 years
• Change from baseline in physical functioning over
time while receiving treatment as assessed through
use of the five-item Physical Functioning subscale
(Questions 1−5) of the EORTC QLQ-C30
• Change from baseline in HRQoL over time while
receiving treatment as assessed through use of the
two-item GHS/HRQoL subscale (Questions 29 and
30) of the EORTC QLQ-C30
• Incidence and severity of adverse events, including
serious adverse events and immune-related
adverse events, with severity determined according
to NCI CTCAE v4.0
• IRF-assessed EFS, defined as the time from
randomization to the first documented disease
recurrence (per unequivocal radiographic evidence
of local recurrence, new primary lesion, or
development of distant metastasis), or disease
progression (per RECIST v1.1) or death from any
cause, whichever occurs first
• OS after randomization, defined as the time from
randomization to death from any cause
Secondary
• Investigator-assessed EFS, defined as the time
from randomization to the first documented disease
recurrence (per unequivocal radiographic evidence
of local recurrence, new primary lesion, or
development of distant metastasis), or disease
progression (per RECIST v1.1) or death from any
cause, whichever occurs first
• IRF-assessed EFS and investigator-assessed EFS
at 1 and 2 years
• OS at 1, 2, and 3 years
• Change from baseline in physical functioning over
time while receiving treatment as assessed through
use of the five-item Physical Functioning subscale
(Questions 1−5) of the EORTC QLQ-C30
• Change from baseline in HRQoL over time while
receiving treatment as assessed through use of the
two-item GHS/HRQoL subscale (Questions 29 and
30) of the EORTC QLQ-C30
• Incidence and severity of adverse events, including
serious adverse events and immune-related
adverse events, with severity determined according
to NCI CTCAE v4.0
Inclution Criteria
Inclusion Criteria
Patients must meet the following criteria for study entry:
• Signed Informed Consent Form
• Age ≥ 18 years at the time of signing the Informed Consent Form
• Ability to comply with the study protocol, in the investigator's judgment
• Histologically or cytologically confirmed SCCHN (HPV positive Stage III or
HPV negative Stave IVA or IVB based on AJCC 8th Edition Cancer Staging Manual)
involving the oral cavity, oropharynx, larynx, or hypopharynx
– HPV negative Stage IVA (T3/T4a+ N2M0) regardless of tobacco use history
– HPV negative Stage IVB (T3/T4a+ N3M0 or T4b+N2/N3M0) regardless of
tobacco use history
– HPV-positive oropharyngeal carcinoma Stage III (clinical T1/T2+ N3M0) and
≥ 10 years of tobacco use history
– HPV-positive oropharyngeal carcinoma Stage III (clinical T3/T4+ N3M0 or
pathologic T3/T4+ N2M0) regardless of tobacco use history
• HPV status as determined locally by p16 IHC, in situ hybridization, or by polymerase
chain reaction−based assay
• Completed definitive local therapy (as defined below) and have scans (MRI or CT
with contrast of head and neck region; CT with contrast of chest, abdomen, and
pelvis) 10−12 weeks after completion of definitive local therapy confirming either
CR, PR, or SD and within 4 weeks of randomization
– Primary surgery followed by either postoperative RT or concurrent CRT
– Induction chemotherapy followed by primary surgery alone (e.g., laryngectomy);
or induction chemotherapy follow by primary surgery followed by RT or CRT; or
induction chemotherapy followed by RT or CRT alone
– Concurrent CRT without primary or salvage surgery
– CRT followed by salvage neck dissection or salvage laryngectomy (only for
patients with laryngeal cancer)
Absence of metastatic disease as documented by radiographic scans
• Recovered from acute toxicities, except fatigue, xerostomia, dysgeusia, alopecia,
associated with definitive treatment to Grade 1 or lower
• Patients with feeding tubes are eligible
• Availability of a representative pretreatment tumor specimen for exploratory
biomarker research (see Section 4.5.6 for information on tumor specimens)
The tissue sample must be submitted before or within 4 weeks after
randomization; however, patients may be enrolled into the study before the
pretreatment tumor tissue sample is submitted.
• ECOG PS of 0 or 1
• Life expectancy ≥ 12 weeks
• Adequate hematologic and end-organ function, defined by the following laboratory
test results, obtained within 14 days prior to initiation of study treatment:
– ANC ≥ 1.5×109
/L (1500/µL) without granulocyte colony-stimulating factor
support
– Lymphocyte count ≥ 0.3×109
/L (300/µL)
– Platelet count ≥ 100× 109
/L (100,000/µL) without transfusion
– Hemoglobin ≥ 90 g/L (9 g/dL)
Patients may be transfused to meet this criterion.
– AST, ALT, and ALP ≤ 2.5× ULN
– Serum bilirubin ≤ 1.5× ULN with the following exception:
Patients with known Gilbert disease: serum bilirubin level ≤ 3 × ULN
– Creatinine CL ≥ 20 mL/min (calculated by Cockcroft-Gault formula)
– Serum albumin ≥ 25 g/L (2.5 g/dL)
– For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5× ULN
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
• Negative HIV test at screening
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total
HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
The HBV DNA test will be performed only for patients who have a positive total
HBcAb test.
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV
antibody test followed by a negative HCV RNA test at screening
The HCV RNA test will be performed only for patients who have a positive
HCV antibody test.
• For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods with a failure rate of
< 1% per year during the treatment period and for 5 months after the last dose of
study treatment
A woman is considered to be of childbearing potential if she is postmenarcheal,
has not reached a postmenopausal state (≥12 continuous months of
amenorrhea with no identified cause other than menopause), and has not
undergone surgical sterilization (removal of ovaries and/or uterus).
Examples of contraceptive methods with a failure rate of < 1% per year include
bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit
ovulation, hormone-releasing intrauterine devices, and copper intrauterine
devices.
The reliability of sexual abstinence should be evaluated in relation to the
duration of the clinical trial and the preferred and usual lifestyle of the patient.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation
methods) and withdrawal are not acceptable methods of contraception.
Patients must meet the following criteria for study entry:
• Signed Informed Consent Form
• Age ≥ 18 years at the time of signing the Informed Consent Form
• Ability to comply with the study protocol, in the investigator's judgment
• Histologically or cytologically confirmed SCCHN (HPV positive Stage III or
HPV negative Stave IVA or IVB based on AJCC 8th Edition Cancer Staging Manual)
involving the oral cavity, oropharynx, larynx, or hypopharynx
– HPV negative Stage IVA (T3/T4a+ N2M0) regardless of tobacco use history
– HPV negative Stage IVB (T3/T4a+ N3M0 or T4b+N2/N3M0) regardless of
tobacco use history
– HPV-positive oropharyngeal carcinoma Stage III (clinical T1/T2+ N3M0) and
≥ 10 years of tobacco use history
– HPV-positive oropharyngeal carcinoma Stage III (clinical T3/T4+ N3M0 or
pathologic T3/T4+ N2M0) regardless of tobacco use history
• HPV status as determined locally by p16 IHC, in situ hybridization, or by polymerase
chain reaction−based assay
• Completed definitive local therapy (as defined below) and have scans (MRI or CT
with contrast of head and neck region; CT with contrast of chest, abdomen, and
pelvis) 10−12 weeks after completion of definitive local therapy confirming either
CR, PR, or SD and within 4 weeks of randomization
– Primary surgery followed by either postoperative RT or concurrent CRT
– Induction chemotherapy followed by primary surgery alone (e.g., laryngectomy);
or induction chemotherapy follow by primary surgery followed by RT or CRT; or
induction chemotherapy followed by RT or CRT alone
– Concurrent CRT without primary or salvage surgery
– CRT followed by salvage neck dissection or salvage laryngectomy (only for
patients with laryngeal cancer)
Absence of metastatic disease as documented by radiographic scans
• Recovered from acute toxicities, except fatigue, xerostomia, dysgeusia, alopecia,
associated with definitive treatment to Grade 1 or lower
• Patients with feeding tubes are eligible
• Availability of a representative pretreatment tumor specimen for exploratory
biomarker research (see Section 4.5.6 for information on tumor specimens)
The tissue sample must be submitted before or within 4 weeks after
randomization; however, patients may be enrolled into the study before the
pretreatment tumor tissue sample is submitted.
• ECOG PS of 0 or 1
• Life expectancy ≥ 12 weeks
• Adequate hematologic and end-organ function, defined by the following laboratory
test results, obtained within 14 days prior to initiation of study treatment:
– ANC ≥ 1.5×109
/L (1500/µL) without granulocyte colony-stimulating factor
support
– Lymphocyte count ≥ 0.3×109
/L (300/µL)
– Platelet count ≥ 100× 109
/L (100,000/µL) without transfusion
– Hemoglobin ≥ 90 g/L (9 g/dL)
Patients may be transfused to meet this criterion.
– AST, ALT, and ALP ≤ 2.5× ULN
– Serum bilirubin ≤ 1.5× ULN with the following exception:
Patients with known Gilbert disease: serum bilirubin level ≤ 3 × ULN
– Creatinine CL ≥ 20 mL/min (calculated by Cockcroft-Gault formula)
– Serum albumin ≥ 25 g/L (2.5 g/dL)
– For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5× ULN
• For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
• Negative HIV test at screening
• Negative hepatitis B surface antigen (HBsAg) test at screening
• Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total
HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
The HBV DNA test will be performed only for patients who have a positive total
HBcAb test.
• Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV
antibody test followed by a negative HCV RNA test at screening
The HCV RNA test will be performed only for patients who have a positive
HCV antibody test.
• For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive methods with a failure rate of
< 1% per year during the treatment period and for 5 months after the last dose of
study treatment
A woman is considered to be of childbearing potential if she is postmenarcheal,
has not reached a postmenopausal state (≥12 continuous months of
amenorrhea with no identified cause other than menopause), and has not
undergone surgical sterilization (removal of ovaries and/or uterus).
Examples of contraceptive methods with a failure rate of < 1% per year include
bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit
ovulation, hormone-releasing intrauterine devices, and copper intrauterine
devices.
The reliability of sexual abstinence should be evaluated in relation to the
duration of the clinical trial and the preferred and usual lifestyle of the patient.
Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation
methods) and withdrawal are not acceptable methods of contraception.
Exclusion Criteria
Exclusion Criteria
Patients who meet any of the following criteria will be excluded from study entry:
• Patients who have received surgery alone as definitive local therapy
• HPV-negative patients who have a T1/T2 or N0/N1 tumor
• HPV-positive oropharyngeal carcinoma patients who have a clinical N0/N1/N2 or
pathological N0/N1 nodal stage
• Patients, other than laryngeal cancer patients, who have persistent disease at the
primary site and require salvage resection of primary tumor post CRT
• Squamous cell carcinoma of the nasopharynx
• Evidence of disease progression or metastatic disease during or following definitive
local therapy documented in the 10- to 12-week post-definitive local therapy scans
• Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L,
calcium >12 mg/dL or corrected serum calcium >ULN)
• Active or history of autoimmune disease or immune deficiency, including, but not
limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid
antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré
syndrome, or multiple sclerosis (see Appendix 7 for a more comprehensive list of
autoimmune diseases and immune deficiencies), with the following exceptions:
Patients with a history of autoimmune-related hypothyroidism who are on
thyroid-replacement hormone are eligible for the study.
Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen
are eligible for the study.
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis are
excluded) are eligible for the study provided all of following conditions are met:
− Rash must cover <10% of body surface area.
− Disease is well controlled at baseline and requires only low-potency topical
corticosteroids.
− No occurrence of acute exacerbations of the underlying condition requiring
psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents,
oral calcineurin inhibitors, or high-potency or oral corticosteroids within the
previous 12 months.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest CT scan
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Active tuberculosis
• Significant cardiovascular disease (such as New York Heart Association Class II or
greater cardiac disease, myocardial infarction, or cerebrovascular accident) within
3 months prior to initiation of study treatment, unstable arrhythmia, or unstable
angina
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation
of study treatment, or anticipation of need for a major surgical procedure during the
study
• History of malignancy other than SCCHN within 5 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year
OS rate >90%), such as adequately treated carcinoma in situ of the cervix,
non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ,
or Stage I uterine cancer
• Severe infection within 4 weeks prior to initiation of study treatment, including, but
not limited to, hospitalization for complications of infection, bacteremia, or severe
pneumonia
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of
study treatment
Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract
infection or chronic obstructive pulmonary disease exacerbation) may be
eligible for the study.
• Prior allogeneic stem cell or solid organ transplantation
• Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that contraindicates the use of an investigational drug, may affect
the interpretation of the results, or may render the patient at high risk from treatment
complications
• Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment, or anticipation of need for such a vaccine during atezolizumab treatment
or within 5 months after the last dose of atezolizumab
• Current treatment with anti-viral therapy for HBV
• Prior neoadjuvant treatment or any systemic anti-cancer therapy without definitive
local therapy (either surgery and/or radiation) for locally advanced head and neck
cancer
• Treatment with investigational therapy within 28 days prior to initiation of study
treatment
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
including anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents (including, but not limited to,
interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug
(whichever is longer) prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication (including, but not limited
to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
anti−tumor necrosis factor-α [anti−TNF-α] agents) within 2 weeks prior to initiation of
study treatment, or anticipation of need for systemic immunosuppressive medication
during study treatment, with the following exceptions:
Patients who received acute, low-dose systemic immunosuppressant
medication or a one-time pulse dose of systemic immunosuppressant
medication (e.g., 48 hours of corticosteroids for a contrast allergy) may be
eligible for the study after Medical Monitor approval has been obtained.
Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids
for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose
corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible
for the study.
Patients who are receiving low-dose (equivalent to ≤ 10mg prednisone a day)
corticosteroids for radiation induced mucositis, or mucosal edema are eligible
for the study
• History of severe allergic anaphylactic reactions to chimeric or humanized
antibodies or fusion proteins
• Known hypersensitivity to Chinese hamster ovary cell products or to any component
of the atezolizumab formulation
• Pregnancy or breastfeeding, or intention of becoming pregnant during study
treatment or within 5 months after the last dose of study treatment
Women of childbearing potential must have a negative serum pregnancy test
result within 14 days prior to initiation of study treatment.
Patients who meet any of the following criteria will be excluded from study entry:
• Patients who have received surgery alone as definitive local therapy
• HPV-negative patients who have a T1/T2 or N0/N1 tumor
• HPV-positive oropharyngeal carcinoma patients who have a clinical N0/N1/N2 or
pathological N0/N1 nodal stage
• Patients, other than laryngeal cancer patients, who have persistent disease at the
primary site and require salvage resection of primary tumor post CRT
• Squamous cell carcinoma of the nasopharynx
• Evidence of disease progression or metastatic disease during or following definitive
local therapy documented in the 10- to 12-week post-definitive local therapy scans
• Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L,
calcium >12 mg/dL or corrected serum calcium >ULN)
• Active or history of autoimmune disease or immune deficiency, including, but not
limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid
antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré
syndrome, or multiple sclerosis (see Appendix 7 for a more comprehensive list of
autoimmune diseases and immune deficiencies), with the following exceptions:
Patients with a history of autoimmune-related hypothyroidism who are on
thyroid-replacement hormone are eligible for the study.
Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen
are eligible for the study.
Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis are
excluded) are eligible for the study provided all of following conditions are met:
− Rash must cover <10% of body surface area.
− Disease is well controlled at baseline and requires only low-potency topical
corticosteroids.
− No occurrence of acute exacerbations of the underlying condition requiring
psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents,
oral calcineurin inhibitors, or high-potency or oral corticosteroids within the
previous 12 months.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest CT scan
History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Active tuberculosis
• Significant cardiovascular disease (such as New York Heart Association Class II or
greater cardiac disease, myocardial infarction, or cerebrovascular accident) within
3 months prior to initiation of study treatment, unstable arrhythmia, or unstable
angina
• Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation
of study treatment, or anticipation of need for a major surgical procedure during the
study
• History of malignancy other than SCCHN within 5 years prior to screening, with the
exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year
OS rate >90%), such as adequately treated carcinoma in situ of the cervix,
non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ,
or Stage I uterine cancer
• Severe infection within 4 weeks prior to initiation of study treatment, including, but
not limited to, hospitalization for complications of infection, bacteremia, or severe
pneumonia
• Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of
study treatment
Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract
infection or chronic obstructive pulmonary disease exacerbation) may be
eligible for the study.
• Prior allogeneic stem cell or solid organ transplantation
• Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that contraindicates the use of an investigational drug, may affect
the interpretation of the results, or may render the patient at high risk from treatment
complications
• Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study
treatment, or anticipation of need for such a vaccine during atezolizumab treatment
or within 5 months after the last dose of atezolizumab
• Current treatment with anti-viral therapy for HBV
• Prior neoadjuvant treatment or any systemic anti-cancer therapy without definitive
local therapy (either surgery and/or radiation) for locally advanced head and neck
cancer
• Treatment with investigational therapy within 28 days prior to initiation of study
treatment
• Prior treatment with CD137 agonists or immune checkpoint blockade therapies,
including anti−CTLA-4, anti−PD-1, and anti−PD-L1 therapeutic antibodies
• Treatment with systemic immunostimulatory agents (including, but not limited to,
interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug
(whichever is longer) prior to initiation of study treatment
• Treatment with systemic immunosuppressive medication (including, but not limited
to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and
anti−tumor necrosis factor-α [anti−TNF-α] agents) within 2 weeks prior to initiation of
study treatment, or anticipation of need for systemic immunosuppressive medication
during study treatment, with the following exceptions:
Patients who received acute, low-dose systemic immunosuppressant
medication or a one-time pulse dose of systemic immunosuppressant
medication (e.g., 48 hours of corticosteroids for a contrast allergy) may be
eligible for the study after Medical Monitor approval has been obtained.
Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids
for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose
corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible
for the study.
Patients who are receiving low-dose (equivalent to ≤ 10mg prednisone a day)
corticosteroids for radiation induced mucositis, or mucosal edema are eligible
for the study
• History of severe allergic anaphylactic reactions to chimeric or humanized
antibodies or fusion proteins
• Known hypersensitivity to Chinese hamster ovary cell products or to any component
of the atezolizumab formulation
• Pregnancy or breastfeeding, or intention of becoming pregnant during study
treatment or within 5 months after the last dose of study treatment
Women of childbearing potential must have a negative serum pregnancy test
result within 14 days prior to initiation of study treatment.
The Estimated Number of Participants
-
Taiwan
26 participants
-
Global
406 participants
