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

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 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

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