Brief Title
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
Official Title
A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind 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
Brief Summary
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.
Detailed Description
The study design has been amended after the decision to prematurely stop patient accrual due to enrollment challenges. As only 5 participants were enrolled, the study blinding will not be maintained, and placebo infusions will not be administered. Patients assigned to the MOXR0916 arm may continue study treatment with the combination of atezolizumab and MOXR0916 or with atezolizumab alone based on a discussion of benefit and risk with the treating investigator.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-Free Survival (PFS)
Secondary Outcome
Objective Response (OR) According to RECIST v1.1
Condition
Urothelial Carcinoma
Intervention
MOXR0916
Study Arms / Comparison Groups
MOXR0916 plus Atezolizumab
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
5
Start Date
April 27, 2017
Completion Date
April 25, 2018
Primary Completion Date
April 25, 2018
Eligibility Criteria
Inclusion Criteria: - 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 Exclusion Criteria: - 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Trials, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT03029832
Organization ID
GO39590
Secondary IDs
2016-004165-58
Responsible Party
Sponsor
Study Sponsor
Genentech, Inc.
Study Sponsor
Clinical Trials, Study Director, Hoffmann-La Roche
Verification Date
May 2019