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

Completed · Phase 3

Conditions studied: Bladder Cancer

In brief

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 facts

Study ID

NCT02302807

Run by

Hoffmann-La Roche

People needed

931

Starts

2015-01-13

Expected to finish

2018-11-08

Last updated by the study team

2019-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically documented locally advanced or metastatic UBC (including renal pelvis, ureters, urinary bladder, and urethra).
• Representative tumor specimens as specified by the protocol
• Disease progression during or following treatment with at least one platinum-containing regimen for inoperable, locally advanced or metastatic UBC or disease recurrence
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy greater than or equal to (>/=) 12 weeks
• Measurable disease, as defined by RECIST v1.1
• Adequate hematologic and end organ function
• For women of childbearing potential, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab, 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel.
• For men, agreement to refrain from heterosexual intercourse or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of vinflunine and 6 months from the last dose of paclitaxel or docetaxel, and agreement to refrain from donating sperm

You may not qualify if…

• Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
• Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
• Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
• Leptomeningeal disease
• Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome, or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer
• Pregnant and lactating women
• Significant cardiovascular disease
• Severe infections within 4 weeks prior to randomization
• Major surgical procedure other than for diagnosis within 4 weeks prior to randomization
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins; known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
• History of autoimmune disease
• Prior allogeneic stem cell or solid organ transplant
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
• Positive test for human immunodeficiency virus (HIV) and/or active hepatitis B or hepatitis C or tuberculosis
• Administration of a live, attenuated vaccine within 4 weeks prior to randomization
• Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies, including anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1) or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies

Where it is running

• Emory University; Winship Cancer Institute — Atlanta, Georgia, United States
• Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
• Duke Cancer Center — Durham, North Carolina, United States
• Bon Secours - St. Francis Hospital — Greenville, South Carolina, United States
• Vanderbilt-Ingram Cancer Ctr — Nashville, Tennessee, United States
• Royal Brisbane and Women's Hospital; Medical Oncology — Herston, Queensland, Australia
• Royal Adelaide Hospital; Oncology — Adelaide, South Australia, Australia
• Monash Medical Centre; Oncology — Clayton, Victoria, Australia
• Austin and Repatriation Medical Centre; Cancer Services — Melbourne, Victoria, Australia
• Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie — Vienna, Austria
• Kaiser-Franz-Josef-Spital; Zent.Onkologie und Hamatologie — Vienna, Austria
• ZNA Middelheim — Antwerp, Belgium
• Institut Jules Bordet — Brussels, Belgium
• UZ Gent — Ghent, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• Tom Baker Cancer Centre-Calgary — Calgary, Alberta, Canada
• Bcca - Cancer Center Southern Interior — Kelowna, British Columbia, Canada
• BCCA-Vancouver Cancer Centre — Vancouver, British Columbia, Canada
• Bcca - Vancouver Island Cancer Centre; Oncology — Victoria, British Columbia, Canada
• Royal Victoria Hospital — Barrie, Ontario, Canada
• London Regional Cancer Centre — London, Ontario, Canada
• Lakeridge Health Oshawa; Oncology — Oshawa, Ontario, Canada
• The Ottawa Hospital Cancer Centre; Oncology — Ottawa, Ontario, Canada
• Sault Area Hospitals — Sault Ste. Marie, Ontario, Canada
• Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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