A Study of MOXR0916 in Combination with Atezolizumab versus Atezolizumab Alone in Patients with Untreated Locally Advanced or Metastatic Urothelial Carcinoma who are Ineligible for Cisplatin-Based Therapy
- Conditions
- Advanced or Metastatic Urothelial CarcinomaMedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004165-58-BE
- Lead Sponsor
- Genentech, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 225
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of <= 2
- Life expectancy >= 12 weeks
- Histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (UC)
- Availability of a representative tumor specimen to enable central testing for determination of PD-L1 status and exploratory research on biomarkers
- No prior systemic therapy for inoperable locally advanced or metastatic UC
- Ineligible for cisplatin-based chemotherapy as defined by any one of the following criteria:
Impaired renal function (glomerular filtration rate [GFR] > 30 but < 60 mililitre/minute); National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0 Grade >= 2 audiometric hearing loss (25 Decibel at two contiguous frequencies or more severe);
NCI CTCAE v 4.0 Grade >= 2 peripheral neuropathy;
ECOG Performance Status of 2
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1
- Adequate hematologic and end-organ function
- For women of childbearing potential: agreement to remain abstinent or use a contraceptive method with a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of study treatment
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 187
- Pregnant or lactating, or intending to become pregnant or breast feed during the study or 6 months afterward
- Significant cardiovascular disease, such as New York Heart Association cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease
- Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug
- Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment except palliative radiotherapy for bone metastases or soft tissue lesions that is completed > 7 days prior to baseline imaging; radiotherapy for brain metastases; prior local intravesical chemotherapy or immunotherapy is allowed if completed at least 4 weeks prior to the initiation of study treatment; hormone-replacement therapy or oral contraceptives; patients should be recovered from any toxicities associated with permitted anti-cancer therapies
- Prior treatment with CD137 or OX40 agonists, anti- cytotoxic T-lymphocyte-associated protein (CTLA4), anti-PD-1, anti-PD-L1, anti-CD-27, anti- Glucocorticoid-induced tumor necrosis factor receptor (GITR) therapeutic antibody or pathway-targeting agents
- Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to initiation of study treatment
- Untreated central nervous system (CNS) metastases or active (progressing or requiring corticosteroids for symptomatic control) CNS metastases
- Any history of leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled tumor-related pain
- Malignancies other than UC within 5 years prior to Cycle 1, Day 1
- Uncontrolled or symptomatic hypercalcemia
- History of autoimmune disease
- Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study
- Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is longer, prior to initiation of study treatment
- History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography scan
- Active hepatitis B and C virus infection
- Positive HIV test at screening
- Active tuberculosis
- 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
- Prior allogeneic stem cell or solid organ transplantation
- Treatment with a live, attenuated vaccine within 4 weeks before initiation of study treatment, or anticipation of need for such a vaccine during the course of the study
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method