A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy (IMvigor011)

  • STATUS
    Recruiting
  • End date
    Nov 22, 2027
  • participants needed
    495
  • sponsor
    Hoffmann-La Roche
Updated on 13 June 2022

Summary

This is a global Phase III, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with placebo in participants with MIBC who are ctDNA positive and are at high risk for recurrence following cystectomy.

Details
Condition Muscle-invasive Bladder Cancer
Treatment Placebo, Atezolizumab
Clinical Study IdentifierNCT04660344
SponsorHoffmann-La Roche
Last Modified on13 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed MIUC (also termed TCC) of the bladder
TNM classification (based on AJCC Cancer Staging Manual, 7th Edition; Edge et al. 2010) at pathological examination of surgical resection specimen as follows: For patients treated with prior NAC: tumor stage of ypT2-4a or ypN+ and M0. For patients who have not received prior NAC: tumor stage of pT2-4a or pN+ and M0
Surgical resection of MIUC of the bladder
Patients who have not received prior platinum-based NAC, have refused, or are ineligible ("unfit") for cisplatin-based adjuvant chemotherapy. pT2N0 patients who have not received prior platinum-based NAC regardless of cisplatin ineligibility are eligible
ctDNA assay developed based on tumor tissue specimen and matched normal DNA from blood
Tumor PD-L1 expression per IHC that is evaluable by central testing of a representative tumor tissue specimen
Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) or magnetic resonance imaging (MRI) scan of the pelvis, abdomen, and chest no more than 4 weeks prior to enrollment
Full recovery from cystectomy and enrollment within 14 weeks following cystectomy. Minimum of 6 weeks must have elapsed from surgery
Additional Inclusion Criteria for the Treatment Phase
Blood for plasma ctDNA sample evaluated to be ctDNA positive, defined as the presence of two or more mutations based on patient's WES evaluable (ctDNA assay designability) report
Absence of residual disease and absence of metastasis, as confirmed by a negative baseline CT or MRI scan of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization
ECOG Performance Status of <= 2
Life expectancy >=12 weeks
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs

Exclusion Criteria

Pregnancy or breastfeeding
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
History of autoimmune disease. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study. Patients with controlled Type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Patients with active hepatitis B virus or hepatitis C
Active tuberculosis
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, or unstable angina
Cancer-Specific Exclusion Criteria
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to study enrollment
Adjuvant chemotherapy or radiation therapy for UC following cystectomy
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to enrollment
Malignancies other than UC within 5 years prior to study enrollment
Additional Exclusion Criteria for the Treatment Phase
Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to randomization to the treatment phase Hormone-replacement therapy or oral contraceptives are allowed
Positive test for HIV, with the following exception: Patients with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a CD4 count >= 200/μL, and have an undetectable viral load
Adjuvant chemotherapy or radiation therapy for UC following cystectomy
Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lives of the drug, whichever is longer, prior to randomization to the treatment phase
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