Clinical Trials List
Protocol NumberD419BC00001
NCT Number(ClinicalTrials.gov Identfier)NCT02516241
Completed
2015-10-01 - 2020-06-30
Phase III
Recruiting3
Terminated3
ICD-10C67
Malignant neoplasm of bladder
ICD-9188.0
Malignant neoplasm of trigone of urinary bladder
A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 in Combination with Tremelimumab Versus Standard of Care Chemotherapy in Patients with Unresectable Stage IV Urothelial Bladder Cancer
-
Trial Applicant
-
Sponsor
AstraZeneca
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
- Wei-Pang Chung Division of Hematology & Oncology
- Yu-Min Yeh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- 洪啟峰 Division of Urology
- Cheng-Kuang Yang Division of Urology
- Chuan-Shu Chen Division of Urology
- Cheng-Che Chen Division of Urology
- Shian-Shiang Wang Division of Urology
- 熊小澐 Division of Urology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Co-Principal Investigator
- Chueh-Chuan Yen Division of Hematology & Oncology
- Jin-Hwang Liu Division of Hematology & Oncology
- Yen-Hwa Chang Division of Urology
- Hsiao-Jen Chung Division of Urology
- Yi-Hsiu Huang Division of Urology
- Tzeon-jye Chiou Division of Hematology & Oncology
- Mu-Hsin Chang Division of Hematology & Oncology
- Tzu-Ping Lin Division of Urology
The Actual Total Number of Participants Enrolled
6 Terminated
Audit
None
Co-Principal Investigator
- Shau-Hsuan Li Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 陳彥仰 Division of Hematology & Oncology
- 劉建廷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Po-Jung Su Division of Hematology & Oncology
- Rita cheng Division of Hematology & Oncology
- 張英勛 Division of Hematology & Oncology
- Yung-Chia Kao Division of Hematology & Oncology
- 劉忠一 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
7 Terminated
Audit
CRO
Co-Principal Investigator
- - - Division of Urology
- CHUNG-HSIN CHEN Division of Urology
- - - Division of Urology
- Yeong-Shiau Pu Division of Urology
- Chia-Chi Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Urothelial Bladder Cancer
Objectives
Primary objectives
To assess the efficacy of MEDI4736 + tremelimumab combination therapy versus SoC in terms
of PFS in patients with UBC
Secondary objectives
To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in
terms of PFS in patients with PD-L1-negative UBC
To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in
terms of OS in patients with UBC
To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to
MEDI4736 monotherapy in terms of PFS in patients with PD-L1-negative UBC
To assess the efficacy of MEDI4736 monotherapy compared to SoC in terms of PFS in patients
with UBC
To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to
SoC in terms of OS24, APF12, ORR, DoR, DCR, and PFS2 in patients with UBC
To further assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to
SoC in terms of OS, OS24, APF12, ORR, DoR, DCR, and PFS2 in patients with PD-L1-negative
UBC
To further assess the efficacy of MEDI4736 monotherapy therapy compared to SoC in terms of
OS, OS24, APF12, ORR, DoR, DCR, and PFS2 in patients with UBC
To further assess the efficacy of MEDI4736 + tremelimumab therapy compared to MEDI4736
monotherapy in terms of OS, OS24, APF12, ORR, DoR, DCR, and PFS2 in patients with PD-L1
negative UBC
To further assess the efficacy of MEDI4736 + tremelimumab combination therapy and
MEDI4736 monotherapy compared to SoC in patients with PD-L1-positive UBC
To assess disease-related symptoms and HRQoL in UBC patients treated with MEDI4736
monotherapy and MEDI4736 + tremelimumab combination therapy compared with SoC and each
other using the FACT-BL questionnaire
To assess the PK of MEDI4736 monotherapy and MEDI4736 + tremelimumab combination
therapy
To investigate the immunogenicity of MEDI4736 monotherapy and MEDI4736 + tremelimumab
combination therapy
Test Drug
MEDI4736; Tremelimumab
Active Ingredient
MEDI4736
Tremelimumab
Tremelimumab
Dosage Form
Injection
Dosage
50
20
20
Endpoints
1. Primary efficacy variable:
PFS using Investigator assessment based on RECIST 1.1
2. Secondary efficacy variables:
PFS in patients with PD-L1–negative UBC using Investigator assessments according to
RECIST 1.1
OS and OS24
APF12, ORR, DoR, and DCR using Investigator assessment according to RECIST 1.1
PFS2 as defined by local standard clinical practice
FACT-BL: Derived National Comprehensive Cancer Network-FACT Bladder Symptoms
Index-18 (NFBlSI-18) score, physical well-being (PWB), and total score
Concentration of MEDI4736/tremelimumab in blood and non-compartmental PK
parameters (such as peak concentration and trough, as data allow; sparse sampling)
Presence of ADAs for MEDI4736 and tremelimumab (confirmatory results: positive or
negative)
3. Safety variables:
AEs, physical examinations, laboratory findings, vital signs, and ECGs
PFS using Investigator assessment based on RECIST 1.1
2. Secondary efficacy variables:
PFS in patients with PD-L1–negative UBC using Investigator assessments according to
RECIST 1.1
OS and OS24
APF12, ORR, DoR, and DCR using Investigator assessment according to RECIST 1.1
PFS2 as defined by local standard clinical practice
FACT-BL: Derived National Comprehensive Cancer Network-FACT Bladder Symptoms
Index-18 (NFBlSI-18) score, physical well-being (PWB), and total score
Concentration of MEDI4736/tremelimumab in blood and non-compartmental PK
parameters (such as peak concentration and trough, as data allow; sparse sampling)
Presence of ADAs for MEDI4736 and tremelimumab (confirmatory results: positive or
negative)
3. Safety variables:
AEs, physical examinations, laboratory findings, vital signs, and ECGs
Inclution Criteria
For inclusion in the study patients should fulfill the following criteria:
1. Age ≥18 years at the time of screening.
2. Written informed consent and any locally required authorization (eg, Health Insurance
Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in
the EU) obtained from the patient/legal representative prior to performing any protocol-related
procedures, including screening evaluations. (For patients aged <20 years and enrolling in
Japan, a written informed consent should be obtained from the patient and his or her legally
acceptable representative.)
3. Patients with histologically or cytologically documented, unresectable, Stage IV (ie, T4b,
any N; or any T, N2-N3 (Note: The Investigators will use their discretion to confirm the cause
of N2 disease [reactive or inflammatory]); or M1) transitional cell carcinoma (transitional cell
and mixed transitional/non-transitional cell histologies) of the urothelium (including renal
pelvis, ureters, urinary bladder, and urethra), who have not been previously treated with
first-line chemotherapy. (Patients who have received prior definitive chemoradiation for
locally advanced disease, adjuvant treatment, or neoadjuvant treatment are eligible, provided
that progression has occurred >6 months from last therapy [for chemoradiation and adjuvant
treatment] or >6 months from last surgery [for neoadjuvant treatment].)
4. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10
mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with a
computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for
accurate repeated measurements as per Response Evaluation Criteria in Solid Tumors,
version 1.1 (RECIST 1.1) guidelines.
5. Eastern Cooperative Oncology Group (ECOG) PS 0 or 1
6. Life expectancy ≥12 weeks (in the opinion of the Investigator)
7. Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined
as meeting 1 of the following criteria:
- Creatinine clearance (calculated or measured) <60 mL/min
- Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing
loss
- CTCAE Grade 2 peripheral neuropathy
- New York Heart Association Class III heart failure
8. Tumor PD-L1 status, with IHC assay confirmed by a reference laboratory, must be known prior
to randomization. As such, all patients must be able to undergo a fresh tumor biopsy during
screening (strongly encouraged) or provide an available tumor sample taken <3 years prior to
screening. Tumor lesions used for fresh biopsies should not be target lesions, unless there are
no other lesions suitable for biopsy. Fine needle aspirate specimens are not acceptable.
Specimens from metastatic bone lesions are typically unacceptable unless there is a significant
soft tissue component. The tumor specimen submitted to establish eligibility should be of
sufficient quantity to allow for PD-L1 IHC and other exploratory biomarker analyses and is
preferred in formalin-fixed paraffin embedded blocks.
9. Adequate organ and marrow function as defined below:
- Hemoglobin ≥9 g/dL
- Absolute neutrophil count ≥1500/mm3
- Platelet count ≥100000/mm3
- Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to patients with
confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia [predominantly
unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who
will be allowed in consultation with their physician.
- ALT and AST ≤2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤5 × ULN
- Calculated creatinine clearance >40 mL/min as determined by Cockcroft-Gault (using actual
body weight; see Appendix B)
10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female
pre-menopausal patients. Women will be considered post-menopausal if they have been
amenorrheic for 12 months without an alternative medical cause. The following age-specific
requirements apply:
- Women <50 years of age would be considered postmenopausal if they have been
amenorrheic for 12 months or more following cessation of exogenous hormonal treatments
and if they have luteinizing hormone and follicle-stimulating hormone levels in the
post-menopausal range for the institution.
- Women ≥50 years of age would be considered postmenopausal if they have been
amenorrheic for 12 months or more following cessation of all exogenous hormonal
treatments, had radiation-induced oophorectomy with last menses >1 year ago, had
chemotherapy-induced menopause with >1 year interval since last menses, or underwent
surgical sterilization (bilateral oophorectomy or hysterectomy).
1. Age ≥18 years at the time of screening.
2. Written informed consent and any locally required authorization (eg, Health Insurance
Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in
the EU) obtained from the patient/legal representative prior to performing any protocol-related
procedures, including screening evaluations. (For patients aged <20 years and enrolling in
Japan, a written informed consent should be obtained from the patient and his or her legally
acceptable representative.)
3. Patients with histologically or cytologically documented, unresectable, Stage IV (ie, T4b,
any N; or any T, N2-N3 (Note: The Investigators will use their discretion to confirm the cause
of N2 disease [reactive or inflammatory]); or M1) transitional cell carcinoma (transitional cell
and mixed transitional/non-transitional cell histologies) of the urothelium (including renal
pelvis, ureters, urinary bladder, and urethra), who have not been previously treated with
first-line chemotherapy. (Patients who have received prior definitive chemoradiation for
locally advanced disease, adjuvant treatment, or neoadjuvant treatment are eligible, provided
that progression has occurred >6 months from last therapy [for chemoradiation and adjuvant
treatment] or >6 months from last surgery [for neoadjuvant treatment].)
4. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10
mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with a
computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for
accurate repeated measurements as per Response Evaluation Criteria in Solid Tumors,
version 1.1 (RECIST 1.1) guidelines.
5. Eastern Cooperative Oncology Group (ECOG) PS 0 or 1
6. Life expectancy ≥12 weeks (in the opinion of the Investigator)
7. Patients eligible or ineligible for cisplatin-based chemotherapy. Cisplatin ineligibility is defined
as meeting 1 of the following criteria:
- Creatinine clearance (calculated or measured) <60 mL/min
- Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing
loss
- CTCAE Grade 2 peripheral neuropathy
- New York Heart Association Class III heart failure
8. Tumor PD-L1 status, with IHC assay confirmed by a reference laboratory, must be known prior
to randomization. As such, all patients must be able to undergo a fresh tumor biopsy during
screening (strongly encouraged) or provide an available tumor sample taken <3 years prior to
screening. Tumor lesions used for fresh biopsies should not be target lesions, unless there are
no other lesions suitable for biopsy. Fine needle aspirate specimens are not acceptable.
Specimens from metastatic bone lesions are typically unacceptable unless there is a significant
soft tissue component. The tumor specimen submitted to establish eligibility should be of
sufficient quantity to allow for PD-L1 IHC and other exploratory biomarker analyses and is
preferred in formalin-fixed paraffin embedded blocks.
9. Adequate organ and marrow function as defined below:
- Hemoglobin ≥9 g/dL
- Absolute neutrophil count ≥1500/mm3
- Platelet count ≥100000/mm3
- Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to patients with
confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia [predominantly
unconjugated bilirubin] in the absence of evidence of hemolysis or hepatic pathology), who
will be allowed in consultation with their physician.
- ALT and AST ≤2.5 × ULN; for patients with hepatic metastases, ALT and AST ≤5 × ULN
- Calculated creatinine clearance >40 mL/min as determined by Cockcroft-Gault (using actual
body weight; see Appendix B)
10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female
pre-menopausal patients. Women will be considered post-menopausal if they have been
amenorrheic for 12 months without an alternative medical cause. The following age-specific
requirements apply:
- Women <50 years of age would be considered postmenopausal if they have been
amenorrheic for 12 months or more following cessation of exogenous hormonal treatments
and if they have luteinizing hormone and follicle-stimulating hormone levels in the
post-menopausal range for the institution.
- Women ≥50 years of age would be considered postmenopausal if they have been
amenorrheic for 12 months or more following cessation of all exogenous hormonal
treatments, had radiation-induced oophorectomy with last menses >1 year ago, had
chemotherapy-induced menopause with >1 year interval since last menses, or underwent
surgical sterilization (bilateral oophorectomy or hysterectomy).
Exclusion Criteria
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
1. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca/MedImmune staff and/or staff at the study site)
2. Previous IP assignment in the present study
3. Concurrent enrollment in another clinical study, unless it is an observational (noninterventional)
clinical study or during the follow-up period of an interventional study
4. Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin,
BCG), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2
antibodies, including therapeutic anticancer vaccines
5. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the
exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Patients with Grade <2 neuropathy will be evaluated on a case-by-case basis after
consultation with the Study Physician.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment
with MEDI4736 or tremelimumab may be included after consultation with the Study
Physician.
6. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone
replacement therapy) is acceptable. Note: Local treatment of isolated lesions, excluding target
lesions, for palliative intent is acceptable (eg, local surgery or radiotherapy).
7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation
within 4 weeks of the first dose of study drug
8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose
of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
9. History of allogenic organ transplantation that requires use of immunosuppressive agents.
10. Active or prior documented autoimmune or inflammatory disorders (including inflammatory
bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of
diverticulosis], celiac disease, irritable bowel disease, or other serious gastrointestinal chronic
conditions associated with diarrhea, systemic lupus erythematosus, Sarcoidosis syndrome, or
Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis,
hypophysitis, uveitis, etc]) within the past 3 years prior to the start of treatment. The
following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone
replacement of psoriasis not requiring systemic treatment
11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection,
symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris,
cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would
limit compliance with study requirement, substantially increase risk of incurring AEs or
compromise the ability of the patient to give written informed consent
12. Other malignancy within 5 years except for noninvasive malignancies such as cervical
carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the
breast that has been surgically cured. Cancer patients with incidental histologic findings of
prostate cancer (tumor/node/metastasis stage of T1a or T1b or prostate-specific antigen <10)
who have not received hormonal treatment may be included, pending a discussion with the
Study Physician.
13. History of leptomeningeal carcinomatosis
14. Brain metastases or spinal cord compression. Patients with suspected brain metastases at
screening should have a CT/ MRI of the brain prior to study entry.
15. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≥470 ms calculated
from 3 ECGs (within 5 minutes at least 1 minute apart)
16. History of active primary immunodeficiency
17. Known history of clinical diagnosis of tuberculosis
18. Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
19. Current or prior use of immunosuppressive medication within 14 days before the first dose of
MEDI4736 or tremelimumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its
equivalent
- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
20. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if
enrolled, should not receive live vaccine during the study and up to 30 days after the last dose
of IP.
21. Female patients who are pregnant or breastfeeding or male or female patients of reproductive
potential who are not willing to employ effective birth control from screening to 90 days after
the last dose of MEDI4736 monotherapy or 180 days after the last dose of MEDI4736 +
tremelimumab combination therapy
22. Known allergy or hypersensitivity to IP or any IP excipient, or to other humanized mAbs
23. Any medical contraindication to platinum (cisplatin or carboplatin)-based doublet
chemotherapy
24. Patient <30 kg in weight
1. Involvement in the planning and/or conduct of the study (applies to both
AstraZeneca/MedImmune staff and/or staff at the study site)
2. Previous IP assignment in the present study
3. Concurrent enrollment in another clinical study, unless it is an observational (noninterventional)
clinical study or during the follow-up period of an interventional study
4. Prior exposure to immune-mediated therapy (with exclusion of Bacillus Calmette Guerin,
BCG), including but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2
antibodies, including therapeutic anticancer vaccines
5. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the
exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Patients with Grade <2 neuropathy will be evaluated on a case-by-case basis after
consultation with the Study Physician.
- Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment
with MEDI4736 or tremelimumab may be included after consultation with the Study
Physician.
6. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone
replacement therapy) is acceptable. Note: Local treatment of isolated lesions, excluding target
lesions, for palliative intent is acceptable (eg, local surgery or radiotherapy).
7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation
within 4 weeks of the first dose of study drug
8. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose
of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
9. History of allogenic organ transplantation that requires use of immunosuppressive agents.
10. Active or prior documented autoimmune or inflammatory disorders (including inflammatory
bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of
diverticulosis], celiac disease, irritable bowel disease, or other serious gastrointestinal chronic
conditions associated with diarrhea, systemic lupus erythematosus, Sarcoidosis syndrome, or
Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis,
hypophysitis, uveitis, etc]) within the past 3 years prior to the start of treatment. The
following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone
replacement of psoriasis not requiring systemic treatment
11. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection,
symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris,
cardiac arrhythmia, interstitial lung disease, or psychiatric illness/social situations that would
limit compliance with study requirement, substantially increase risk of incurring AEs or
compromise the ability of the patient to give written informed consent
12. Other malignancy within 5 years except for noninvasive malignancies such as cervical
carcinoma in situ, non-melanomatous carcinoma of the skin, or ductal carcinoma in situ of the
breast that has been surgically cured. Cancer patients with incidental histologic findings of
prostate cancer (tumor/node/metastasis stage of T1a or T1b or prostate-specific antigen <10)
who have not received hormonal treatment may be included, pending a discussion with the
Study Physician.
13. History of leptomeningeal carcinomatosis
14. Brain metastases or spinal cord compression. Patients with suspected brain metastases at
screening should have a CT/ MRI of the brain prior to study entry.
15. Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) ≥470 ms calculated
from 3 ECGs (within 5 minutes at least 1 minute apart)
16. History of active primary immunodeficiency
17. Known history of clinical diagnosis of tuberculosis
18. Active infection including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
19. Current or prior use of immunosuppressive medication within 14 days before the first dose of
MEDI4736 or tremelimumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its
equivalent
- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
20. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if
enrolled, should not receive live vaccine during the study and up to 30 days after the last dose
of IP.
21. Female patients who are pregnant or breastfeeding or male or female patients of reproductive
potential who are not willing to employ effective birth control from screening to 90 days after
the last dose of MEDI4736 monotherapy or 180 days after the last dose of MEDI4736 +
tremelimumab combination therapy
22. Known allergy or hypersensitivity to IP or any IP excipient, or to other humanized mAbs
23. Any medical contraindication to platinum (cisplatin or carboplatin)-based doublet
chemotherapy
24. Patient <30 kg in weight
The Estimated Number of Participants
-
Taiwan
40 participants
-
Global
1340 participants
