1. Muscle-invasive bladder cancer (MIBC) pT2-T3 histologically confirmed:
Urothelial and squamous cell histological types are allowed. De novo MIBC or after a history of non-muscle-invasive bladder cancer.
2. Complete transurethral resection of bladder tumour (TURBT), either:
within 6 weeks of selection if no chemotherapy was administered, or before starting chemotherapy.
3. Patients for which chemo-radiotherapy is planned
4. No major pelvic involvement: pelvic nodes ≤15 mm on CT scan.
5. No distant metastasis.
6. Patient unfit for radical cystectomy because of age, comorbidities, or patient's refusal.
7. Patients ≥18 years old
8. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
9. Life expectancy ≥12 months.
10. Haematological and biological parameters:
White blood cell count ≥4000/mm³ Platelet count ≥100000 cells/mm³ Haemoglobin level ≥9 g/dL or corrected after transfusion Adequate renal function: clearance \>50 mL/min (Cockcroft). Adequate hepatic function: Aspartate aminotransferase (AST \[SGOT\]) and Alanine aminotransferase (ALT \[SGPT\]) ≤2.5 x upper limit of normal (ULN), or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible.
11. Patients of childbearing potential who agree to use a medically acceptable method of contraception during the study and for 120 days after the last study treatment. Women must have a negative urine or serum pregnancy test before receiving the study treatment and within 14 days prior to selection.
12. Patients having provided written informed consent prior to any study-related procedures.
13. Patients affiliated to the social security scheme.
14. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
15. Patient consents to the use of their collected tumour specimen, as well as, blood samples as detailed in the protocol for future scientific research which includes but not limited to DNA, RNA, and protein-based biomarker detection.
Exclusion Criteria:
1. Prior pelvic irradiation.
2. MIBC histology other than urothelial or squamous cell carcinomas (e.g., adenocarcinomas, micropapillary, sarcomas, or small cell histological types).
3. History of neoplastic disease, during the 3 years before selection, except completely resected cutaneous basal-cell carcinomas, carcinoma in-situ or localised prostate cancer without biochemical recurrence following definitive treatment.
4. Prior treatment with CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4), anti-programmed death-1 receptor (anti-PD-1), and anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibodies.
5. Contraindications for pelvic radiotherapy (e.g., inflammatory bowel disease).
6. History of immunodeficiency, including HIV infection, or systemic steroid therapy for any other disease.
7. A history of active autoimmune disease, except autoimmune-related hypothyroidism and type I diabetes mellitus (see appendix 5).
8. History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins.
9. Known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation.
10. Prior allogeneic stem cell or solid organ transplant.
11. Patients with the following severe acute co-morbidity are not eligible:
Unstable angina or congestive heart failure that required hospitalisation in the 6 months before selection.
Transmural myocardial infarction in the 6 months prior to selection. Acute bacterial or fungal infection requiring intravenous antibiotics at selection.
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalisation or precluding study therapy at the time of selection.
Severe hepatic disease: Child-Pugh Class B or C.
12. Patients with any other disease or illness which requires hospitalisation or is incompatible with the study treatment are not eligible.
13. Patients unable to comply with study obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the study.
14. Patients enrolled in another therapeutic study within 30 days of selection.
15. Pregnant or breast feeding women.
16. Person deprived of their liberty or under protective custody or guardianship.
Inclusion phase
Inclusion Criteria:
1. Patients who have received standard (chemo)-radiotherapy ≥60 gray (Gy) or equivalent on the bladder according to the local practice.
2. The first administration of atezolizumab must be performed 30 (+/-5) days after the last session of radiotherapy (RT).
3. ECOG performance status ≤2.
4. Haematological and biological parameters:
White blood cell count ≥3000/mm³ Platelet count ≥100000 cells/mm³ Haemoglobin level ≥9 g/dL or corrected after transfusion Adequate renal function: clearance \>50 mL/min (Cockcroft) Adequate hepatic function: AST (SGOT) and ALT (SGPT) ≤2.5 x ULN, or ≤3.5 x ULN in the case of concurrent disease with known etiology and for which a corrective treatment is possible.
5. Patients of childbearing potential who agree to use a medically acceptable method of contraception during the study and for 120 days after the last study treatment. Women must have a negative urine or serum pregnancy test before receiving the study treatment and within 14 days prior to inclusion.
6. Patients having provided written informed consent prior to any study-related procedures.
7. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
8. Patient consents to the use of their collected tumour specimen, as well as, blood samples as detailed in the protocol for future scientific research which includes but not limited to DNA, RNA, and protein-based biomarker detection.
Exclusion Criteria:
The same non-inclusion criteria of the selection phase have to be respected.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
atezolizumab
Anti-PD-L1 immunotherapy: atezolizumab (1200 mg) administered IV over 1 h every 3 weeks for 12 months (18 injections). Beginning 30 days (±5 days) after chemo-radiotherapy.
Donnée non disponible
Inconnu
atezolizumab
État du recrutement
unknown
Anti-PD-L1 immunotherapy: atezolizumab (1200 mg) administered IV over 1 h every 3 weeks for 12 months (18 injections). Beginning 30 days (±5 days) after chemo-radiotherapy.
Données à jour depuis :
3 décembre 2024
Description de l'étude
Description de l'étude
Résumé de l'étude
Patients older than ≥18 years, with muscle-invasive bladder cancer unfit for radical cystectomy because of age, comorbidities, and/or patient's refusal.
This study is designed as a multicentre, single-arm phase II study.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
10
affichés
sur
12
centres
CENTRE ANTOINE LACASSAGNE CENTRE REGIONAL DE LUTTE CONTRE LE CANCER
Nice
ALPES-MARITIMES, FRANCE
Recrutement local
État du recrutement:
FERMÉ
CENTRE AZUREEN DE CANCEROLOGIE; CONS EXTERNES
Mougins
FRANCE
Recrutement local
État du recrutement:
FERMÉ
CENTRE DE LUTTE CONTRE LE CANCER (CLCC) - INSTITUT BERGONIE
Bordeaux
OTHER, FRANCE
Recrutement local
État du recrutement:
FERMÉ
CENTRE GEORGES FRANCOIS LECLERC
Dijon
CÔTE-D'OR, FRANCE
Recrutement local
État du recrutement:
FERMÉ
CENTRE JEAN PERRIN
Clermont-ferrand
PUY-DE-DÔME, FRANCE
Recrutement local
État du recrutement:
FERMÉ
CENTRE OSCAR LAMBRET
Lille
CEDEX B.P 307, FRANCE
Recrutement local
État du recrutement:
FERMÉ
CHU LYON SUD - SERVICE HEMATOLOGIE
Pierre benite
PIERRE BENITE, FRANCE
Recrutement local
État du recrutement:
FERMÉ
HOPITAL SAINT LOUIS
Paris
CEDEX 10, FRANCE
Recrutement local
État du recrutement:
FERMÉ
HÔPITAL PITIE SALPETRIERE - AP-HP
Paris
FRANCE
Recrutement local
État du recrutement:
FERMÉ
ICM VAL D'AURELLE
Montpellier cedex 5
HERAULT, FRANCE
Recrutement local
État du recrutement:
FERMÉ
Centres participants
Source d'information
Dernière modification :
3 décembre 2024
Données à jour depuis :
5 déc.
Origine des données :
clinicaltrials.gov
