Clinical Trials List
Protocol NumberGO29294
NCT Number(ClinicalTrials.gov Identfier)NCT02302807
2015-01-01 - 2018-12-31
Phase III
Terminated4
ICD-10C67.9
Malignant neoplasm of bladder, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9188.9
Malignant neoplasm of bladder, part unspecified
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF MPDL3280A (ANTI−PD-L1 ANTIBODY) COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY
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Trial Applicant
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Sponsor
Hoffmann-La Roche
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Ching-Chan Lin Division of Hematology & Oncology
- Che-Hung Lin Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- CHUNG-HSIN CHEN Division of Urology
- - - 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 Stop recruiting
Co-Principal Investigator
- Chueh-Chuan Yen Division of Hematology & Oncology
- Jin-Hwang Liu Division of Hematology & Oncology
- Tzeon-jye Chiou Division of Hematology & Oncology
- Yi-Hsiu Huang Division of Urology
- 沈書慧 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Jian-Ri Li Division of Urology
- 洪啟峰 Division of General Surgery
- Cheng-Kuang Yang Division of Urology
- Cheng-Che Chen Division of Urology
- Chuan-Shu Chen Division of Urology
- 熊小澐 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Urothelial Bladder Cancer
Objectives
EFFICACY OBJECTIVES
For the primary and secondary efficacy objectives, a comparison of the treatment arms
will be performed in different patient subpopulations according to tumor PD-L1
expression as evaluated by IHC. The IHC scores will have three categories (IHC 0,
IHC 1, and IHC 2/3), which will also be used for stratification (IHC 0/1 vs. IHC 2/3).
Primary Efficacy Objective
The primary objective of this study is as follows:
• To evaluate the efficacy of MPDL3280A treatment compared with chemotherapy
treatment with respect to OS in patients with locally advanced or metastatic UBC who
have progressed during or following a platinum-containing regimen
Secondary Efficacy Objectives
The secondary efficacy objectives of this study are as follows:
• To evaluate the efficacy of MPDL3280A compared with chemotherapy with respect to
anti-tumor effects as measured by ORR per investigator with use of RECIST v1.1
• To evaluate the efficacy of MPDL3280A compared with chemotherapy with respect to
anti-tumor effects as measured by PFS per investigator with use of RECIST v1.1
• To evaluate the efficacy of MPDL3280A compared with chemotherapy with respect to
anti-tumor effects as measured by duration of objective response (DOR) per
RECIST v1.1
Test Drug
TECENTRIQ® (Atezolizumab)
Active Ingredient
Atezolizumab
Dosage Form
Injection
Dosage
1200mg/20ml
Endpoints
Primary Efficacy Outcome Measure
• OS, defined as the time between the date of randomization and death due to any
cause
Secondary Efficacy Outcome Measures
• ORR, defined as the proportion of patients with an objective response (either a CR or
PR) as determined by the investigator with use of RECIST v1.1
• PFS, defined as the time between the date of randomization and the date of first
documented disease progression as determined by the investigator with use of
RECIST v1.1 or death due to any cause, whichever occurs first
• DOR, defined as the time between the date of first documented response and the
date of first documented disease progression as determined by the investigator with
use of RECIST v1.1 or death due to any cause, whichever occurs first
Safety Outcome Measures
• Incidence, nature, and severity of adverse events graded according to
NCI CTCAE v4.0
• Changes in vital signs, physical findings, and clinical laboratory results
• Incidence of ATA response to MPDL3280A and potential correlation with PK,
pharmacodynamic, safety, and efficacy parameters
• OS, defined as the time between the date of randomization and death due to any
cause
Secondary Efficacy Outcome Measures
• ORR, defined as the proportion of patients with an objective response (either a CR or
PR) as determined by the investigator with use of RECIST v1.1
• PFS, defined as the time between the date of randomization and the date of first
documented disease progression as determined by the investigator with use of
RECIST v1.1 or death due to any cause, whichever occurs first
• DOR, defined as the time between the date of first documented response and the
date of first documented disease progression as determined by the investigator with
use of RECIST v1.1 or death due to any cause, whichever occurs first
Safety Outcome Measures
• Incidence, nature, and severity of adverse events graded according to
NCI CTCAE v4.0
• Changes in vital signs, physical findings, and clinical laboratory results
• Incidence of ATA response to MPDL3280A and potential correlation with PK,
pharmacodynamic, safety, and efficacy parameters
Inclution Criteria
Inclusion Criteria:
• Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra).
• Representative tumor specimens as specified by the protocol
• Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy greater than or equal to (>/=) 12 weeks
• Measurable disease, as defined by RECIST v1.1
• Adequate hematologic and end organ function
• For women of childbearing potential, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel.
• For men, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm
• Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra).
• Representative tumor specimens as specified by the protocol
• Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy greater than or equal to (>/=) 12 weeks
• Measurable disease, as defined by RECIST v1.1
• Adequate hematologic and end organ function
• For women of childbearing potential, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel.
• For men, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm
Exclusion Criteria
Exclusion Criteria:
• Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
• Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
• Leptomeningeal disease
• Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer
• Pregnant and lactating women
• Significant cardiovascular disease
• Severe infections within 4 weeks prior to randomization
• Major surgical procedure other than for diagnosis within 4 weeks prior to randomization
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• History of autoimmune disease
• Prior allogeneic stem cell or solid organ transplant
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
• Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
• Administration of a live, attenuated vaccine within 4 weeks prior to randomization
• Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies
• Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
• Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
• Leptomeningeal disease
• Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer
• Pregnant and lactating women
• Significant cardiovascular disease
• Severe infections within 4 weeks prior to randomization
• Major surgical procedure other than for diagnosis within 4 weeks prior to randomization
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• History of autoimmune disease
• Prior allogeneic stem cell or solid organ transplant
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
• Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
• Administration of a live, attenuated vaccine within 4 weeks prior to randomization
• Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies
The Estimated Number of Participants
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Taiwan
12 participants
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Global
931 participants
