Informations générales (source: ClinicalTrials.gov)
A Phase III, Double-Blind, Multicenter, Randomized Study of Atezolizumab (Anti-PDL1 Antibody) Versus Placebo as Adjuvant Therapy in Patients With High-Risk Muscle-Invasive Bladder Cancer Who Are ctDNA Positive Following Cystectomy
Interventional
Phase 3
Hoffmann-La Roche (Voir sur ClinicalTrials)
mai 2021
septembre 2026
13 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yohann LORIOT | 27/06/2024 07:57:42 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOPITAL FOCH | lundi 15 septembre 2025 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine Lacassagne - 06189 - Nice - France | Contact (sur clinicalTrials) | ||||
| Centre D'Oncologie de Gentilly - 54100 - Nancy - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63011 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Léon Bérard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Hopital Saint Andre - 33075 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| ICO Paul Papin - 49055 - Angers - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Régaud - 31059 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Institut Mutualiste Montsouris - 75674 - Paris - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84918 - Avignon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria for the Surveillance Phase:
- Histologically confirmed MIUC (also termed TCC) of the bladder
- TNM classification (based on AJCC Cancer Staging Manual, 8th Edition; Amin et al.
2016) 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 must be ineligible for
cisplatin-based adjuvant chemotherapy, have refused it, or will not receive it based
on physician's decision.
- 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 24 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 out of the 16 mutations identified 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 28 days prior
to randomization, as assessed by the investigator and Independent Review Facility
- ECOG Performance Status of <= 2
- Life expectancy >=12 weeks
- Adequate hematologic and end-organ function, investigator decision
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception and agreement to refrain from
donating eggs
General Medical Exclusion Criteria for the Surveillance Phase:
- Known PD-L1 IHC result for adjuvant therapy. The decision for the adjuvant therapy
should not be based on the PD-L1 IHC result.
- Pregnancy or breastfeeding
- 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
- Patients with active hepatitis B virus or hepatitis C. Patients with past HBV
infection or resolved HBV infection are eligible. A negative HBV DNA test must be
obtained in these patients prior to enrollment.
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase
chain reaction is negative for HCV RNA.
- Active tuberculosis confirmed by a test performed within 3 months prior to treatment
initiation.
- 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.
- 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 for the Surveillance Phase:
- 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.
- 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
- 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.
- Patients with active hepatitis B virus or hepatitis C
- Active tuberculosis confirmed by a test performed within 3 months prior to treatment
initiation
- Histologically confirmed MIUC (also termed TCC) of the bladder
- TNM classification (based on AJCC Cancer Staging Manual, 8th Edition; Amin et al.
2016) 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 must be ineligible for
cisplatin-based adjuvant chemotherapy, have refused it, or will not receive it based
on physician's decision.
- 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 24 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 out of the 16 mutations identified 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 28 days prior
to randomization, as assessed by the investigator and Independent Review Facility
- ECOG Performance Status of <= 2
- Life expectancy >=12 weeks
- Adequate hematologic and end-organ function, investigator decision
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraception and agreement to refrain from
donating eggs
General Medical Exclusion Criteria for the Surveillance Phase:
- Known PD-L1 IHC result for adjuvant therapy. The decision for the adjuvant therapy
should not be based on the PD-L1 IHC result.
- Pregnancy or breastfeeding
- 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
- Patients with active hepatitis B virus or hepatitis C. Patients with past HBV
infection or resolved HBV infection are eligible. A negative HBV DNA test must be
obtained in these patients prior to enrollment.
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase
chain reaction is negative for HCV RNA.
- Active tuberculosis confirmed by a test performed within 3 months prior to treatment
initiation.
- 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.
- 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 for the Surveillance Phase:
- 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.
- 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
- 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.
- Patients with active hepatitis B virus or hepatitis C
- Active tuberculosis confirmed by a test performed within 3 months prior to treatment
initiation