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

NCT03029832 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: GO395902016-004165-58
• Study Type: interventional
• Target: 5
• Locations: 5 countries
• Sites: 22

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.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-Free Survival (PFS)

  PFS is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Per RECIST v1.1, progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline); and an absolute increase of \>= 5 millimeter (mm) in the sum of diameters.

  Up to approximately 45 months

• Overall Survival (OS)

  Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death.

  Up to approximately 45 months

Secondary Outcomes (10)

• Objective Response (OR) According to RECIST v1.1

  Up to approximately 45 months

• Duration of Objective Response (DOR) According to RECIST v1.1

  Up to approximately 45 months

• Time to Pain Progression, Pain Palliation, and Fatigue Progression as Measured by Participant-Reported Severity According to the M. D. Anderson Symptom Inventory (MDASI)

  Up to approximately 45 months

• Percentage of Participants Reporting Symptom Interference With Daily Living at the Time of Progression According to the MDASI

  Up to approximately 45 months

• Percentage of Participants With Adverse Event (AEs)

  Up to approximately 45 months

Study Arms (2)

MOXR0916 plus Atezolizumab

EXPERIMENTAL

Drug: MOXR0916; Drug: Atezolizumab

Atezolizumab

ACTIVE COMPARATOR

Drug: Atezolizumab

Interventions

MOXR0916 DRUG

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

MOXR0916 plus Atezolizumab

Atezolizumab DRUG

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

Atezolizumab; MOXR0916 plus Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (22)

Arizona Oncology - HOPE Wilmot

Tucson, Arizona, 85710, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Miami Cancer Institute of Baptist Health, Inc.

Miami, Florida, 33176, United States

Location

University of Chicago; Hematology/Oncology

Chicago, Illinois, 60637, United States

Location

Kansas City - Menorah Medical Center

Kansas City, Kansas, 66209, United States

Location

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

Location

Nebraska Methodist Hospital; Cancer Center

Omaha, Nebraska, 68114, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12208, United States

Location

Columbia University Medical Center; Clinical Research Management Office

New York, New York, 10032, United States

Location

Onc/Hem Care Clin Trials LLC

Cincinnati, Ohio, 45242, United States

Location

SCRI Tennessee Oncology Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Sarah Cannon Research Inst.

Nashville, Tennessee, 37203, United States

Location

Texas Oncology-Baylor Sammons Cancer Center

Dallas, Texas, 75246, United States

Location

Virginia Oncology Associates - Lake Wright Cancer Center

Norfolk, Virginia, 23502, United States

Location

GasthuisZusters Antwerpen

Wilrijk, 2610, Belgium

Location

Princess Margaret Cancer Center

Toronto, Ontario, M5G 1Z5, Canada

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Asan Medical Center - Oncology

Seoul, 05505, South Korea

Location

Leicester Royal Infirmary NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

Barts and the London NHS Trust.

London, EC1A 7BE, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study design has been amended in that the study blinding will not be maintained.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 24, 2017
• Study Start: April 27, 2017
• Primary Completion: April 25, 2018
• Study Completion: April 25, 2018
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); US (15); CA (1); BE (1); KR (3)