A Study of MOXR0916 in Combination With Atezolizumab Versus Atezolizumab Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-Based Therapy

Stopped early · Phase 2

Conditions studied: Urothelial Carcinoma

In brief

This is a Phase II, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting and who are ineligible to receive cisplatin-based therapy.

Key facts

Study ID

NCT03029832

Run by

Genentech, Inc.

People needed

5

Starts

2017-04-27

Expected to finish

2018-04-25

Last updated by the study team

2019-05-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 formalin-fixed paraffin-embedded tumor specimen
• 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 milliliter/minute [mL/min]); National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version (v) 4.0 Grade >= 2 audiometric hearing loss (of 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

You may not qualify if…

• Significant cardiovascular disease
• Known clinically significant liver disease
• Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
• Prior treatment with CD137 or OX40 agonists, anti-cytotoxic T-lymphocyte-associated protein (CTLA4), anti-programmed death-1 (PD-1), anti- programmed death-ligand 1 (PD-L1), anti-CD-27, anti- glucocorticoid-induced tumor necrosis factor receptor (GITR) therapeutic antibody or pathway-targeting agents
• Untreated central nervous system (CNS) metastases or active (progressing or requiring corticosteroids for symptomatic control) CNS metastases
• Any history of leptomeningeal disease
• Malignancies other than UC within 5 years prior to Cycle 1, Day 1
• History of autoimmune disease
• 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
• Prior allogeneic stem cell or solid organ transplantation

Where it is running

• Arizona Oncology - HOPE Wilmot — Tucson, Arizona, United States
• University of Colorado — Denver, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• Miami Cancer Institute of Baptist Health, Inc. — Miami, Florida, United States
• University of Chicago; Hematology/Oncology — Chicago, Illinois, United States
• Kansas City - Menorah Medical Center — Kansas City, Kansas, United States
• Maryland Oncology Hematology, P.A. — Columbia, Maryland, United States
• Nebraska Methodist Hospital; Cancer Center — Omaha, Nebraska, United States
• New York Oncology Hematology, P.C. — Albany, New York, United States
• Columbia University Medical Center; Clinical Research Management Office — New York, New York, United States
• Onc/Hem Care Clin Trials LLC — Cincinnati, Ohio, United States
• SCRI Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
• Sarah Cannon Research Inst. — Nashville, Tennessee, United States
• Texas Oncology-Baylor Sammons Cancer Center — Dallas, Texas, United States
• Virginia Oncology Associates - Lake Wright Cancer Center — Norfolk, Virginia, United States
• GasthuisZusters Antwerpen — Wilrijk, Belgium
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• Seoul National University Hospital — Seoul, South Korea
• Severance Hospital, Yonsei University Health System — Seoul, South Korea
• Asan Medical Center - Oncology — Seoul, South Korea
• Leicester Royal Infirmary NHS Trust — Leicester, United Kingdom
• Barts and the London NHS Trust. — London, United Kingdom

Full record on ClinicalTrials.gov

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