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

NCT ID: NCT03029832

Last Updated: 2019-05-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-27
• Study Completion Date: 2018-04-25

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.

Conditions

Urothelial Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MOXR0916 plus Atezolizumab

Group Type: EXPERIMENTAL

MOXR0916

Intervention Type: DRUG

MOXR0916, 300 milligram (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Atezolizumab

Intervention Type: DRUG

Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Atezolizumab

Group Type: ACTIVE_COMPARATOR

Atezolizumab

Intervention Type: DRUG

Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Interventions

MOXR0916

MOXR0916, 300 milligram (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Intervention Type: DRUG

Atezolizumab

Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Countries

United States; Belgium; Canada; South Korea; United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016-004165-58

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO39590

Identifier Type: -

Identifier Source: org_study_id