A Study of Atezolizumab Compared With Chemotherapy in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer [IMvigor211]

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Hoffmann-La Roche
Study ID
NCT02302807
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody — DRUG
    Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
  • Docetaxel — DRUG
    Docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
  • Paclitaxel — DRUG
    Paclitaxel 175 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.
  • Vinflunine — DRUG
    Vinflunine 320 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle.

Study Details

This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of atezolizumab compared with chemotherapy in participants with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen. The anticipated time on study treatment is based on continued clinical benefit, i.e., until disease progression or unacceptable toxicity. The target sample size is 931 participants.

Key Dates

Start date
Jan 13, 2015
Status verified
Jul 2019
Primary completion
Mar 13, 2017
Completion
Nov 8, 2018

Study Design

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

Arms

  • Experimental: Arm A: Atezolizumab
    Atezolizumab will be administered intravenously at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Participants will receive atezolizumab as long as they continue to experience clinical benefit in the opinion of the investigator until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator.
  • Active Comparator: Arm B: Chemotherapy (Vinflunine, Paclitaxel, or Docetaxel)
    Participants randomized to the chemotherapy arm will receive vinflunine, paclitaxel, or docetaxel per the investigator's choice. Vinflunine 320 milligrams per square meter (mg/m\^2), paclitaxel 175 mg/m\^2, or docetaxel 75 mg/m\^2 will be administered intravenously on Day 1 of each 21-day cycle until disease progression per standard RECIST v1.1 or unacceptable toxicity.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Between randomization and death due to any cause, up to approximately 25 months after first participant enrolled ]

Locations (6)

FacilityCityStateZIPSite coordinators
Georgetown University Medical Center Lombardi Cancer CenterWashington D.C.District of Columbia20007-
Emory University; Winship Cancer InstituteAtlantaGeorgia30308-
Comprehensive Cancer Centers of NevadaLas VegasNevada89128-
Duke Cancer CenterDurhamNorth Carolina27710-
Bon Secours - St. Francis HospitalGreenvilleSouth Carolina29607-
Vanderbilt-Ingram Cancer CtrNashvilleTennessee37232-

Find similar trials in Washington D.C., DC

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Georgetown University Medical Center Lombardi Cancer Center· Washington D.C., DCEmory University; Winship Cancer Institute· Atlanta, GAComprehensive Cancer Centers of Nevada· Las Vegas, NVDuke Cancer Center· Durham, NCBon Secours - St. Francis Hospital· Greenville, SCVanderbilt-Ingram Cancer Ctr· Nashville, TN

Related Studies