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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT03029832
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MOXR0916 — DRUG
    MOXR0916, 300 milligram (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.
  • Atezolizumab — DRUG
    Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.

Study Details

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 Dates

Start date
Apr 27, 2017
Status verified
May 2019
Primary completion
Apr 25, 2018
Completion
Apr 25, 2018

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MOXR0916 plus Atezolizumab
  • Active Comparator: Atezolizumab

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: Up to approximately 45 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
Arizona Oncology - HOPE WilmotTucsonArizona85710-
University of ColoradoDenverColorado80045-
Yale UniversityNew HavenConnecticut06510-
Miami Cancer Institute of Baptist Health, Inc.MiamiFlorida33176-
University of Chicago; Hematology/OncologyChicagoIllinois60637-
Kansas City - Menorah Medical CenterKansas CityKansas66209-
Maryland Oncology Hematology, P.A.ColumbiaMaryland21044-
Nebraska Methodist Hospital; Cancer CenterOmahaNebraska68114-
New York Oncology Hematology, P.C.AlbanyNew York12208-
Columbia University Medical Center; Clinical Research Management OfficeNew YorkNew York10032-
Onc/Hem Care Clin Trials LLCCincinnatiOhio45242-
SCRI Tennessee Oncology ChattanoogaChattanoogaTennessee37404-
Sarah Cannon Research Inst.NashvilleTennessee37203-
Texas Oncology-Baylor Sammons Cancer CenterDallasTexas75246-
Virginia Oncology Associates - Lake Wright Cancer CenterNorfolkVirginia23502-

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