Bladder cancer
Conditions
Interventions
Product Code: MPDL3280A-RO5541267-F-03
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: MPDL3280A
Other descriptive name: RO5541267
Concentration
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Ability to comply with protocol •Age > 18 years •Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra) •Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to have sufficient viable tumor content prior to study enrollment; tumor specimens will be evaluated for PD-L1 expression; patients with fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with Medical Monitor. •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Patients with ECOG 2 are allowed in Cohort 1. •Life expectancy > 12 weeks •Measurable disease, as defined by RECIST v1.1 Previously irradiated lesions should not be counted as target lesions. •Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment: •For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate [ 30 but =65 years) yes F.1.3.1 Number of subjects for this age range 65
Exclusion criteria
Exclusion criteria: Cancer Specific Exclusion Criteria •Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed: •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 CT or MRI evaluation during screening and prior radiographic assessments •Leptomeningeal disease •Uncontrolled tumor-related pain •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures •Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab •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 treated with expected curative outcome General Medical Exclusion Criteria •Pregnant and lactating women •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins •Known hypersensitivity to Chinese hamster ovary cell products or any component of the MPDL3280A formulation •History of autoimmune disease •History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan •Serum albumin <2.5 g/dL •Positive test for HIV Medication-Related Exclusion Criteria: •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, •Treatment with systemic immunostimulatory agents within 6 weeks or five half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1 •Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluated the efficacy of MPDL3280A in patients with locally advanced or metastatic urothelial bladder cancer as measured by independent review facility assessed ORR using RECIST v1.1 and investigator assess ORR according to modified RECIST;Secondary Objective: To evaluate PFS, DOR by RECIST v1.1 as assessed by independent review; to evaluate PFS and DOR according to modified RECIST as assessed by investigators; to evaluate ORR, DOR, and PFS according to RECIST v1.1 as assessed by the investigator; to evaluate OS and 1-year OS; to characterize the safety and tolerability of MPDL3280A; to characterize the pharmacokinetics of MPDL3280A; and to evaluate the incidence and tiers of anti-therapeutic antibodies against MPDL3280A;Primary end point(s): IRF-assessed ORR according to RECIST v1.1 and investigator-assessed ORR according to modified RECIST criteria ;Timepoint(s) of evaluation of this end point: Evaluated radiographically every 9 weeks following C1D1 for 1 year, then every 12 weeks. Analysis will be performed approximately 6 months after the last patient is enrolled into the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): DOR and PFS assessed by the IRF and investigator assessed per RECIST v1.1, OS, and 1-year OS; DOR and PFS per modified RECIST;Timepoint(s) of evaluation of this end point: Evaluated radiographically every 9 weeks following C1D1 for 1 year, then every 12 weeks. Analysis will be performed approximately 6 months after the last patient is enrolled into the study. | — |
Countries
Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd
Outcome results
None listed