Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Phase 2

Atezolizumab After Chemo-radiotherapy for MIBC Patients Not Eligible for Radical Cystectomy

NCT03697850 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Phase 2
Started
2018-12-14
Last updated
2025-11-18

Condition(s) studied

Bladder Cancer

Investigational drug(s) / intervention(s)

Atezolizumab →

Atezolizumab: Atezolizumab after adjuvant radio-chemotherapy for the treatment of patients with muscle-invasive bladder cancer not eligible for radical cystectomy

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Selection phase Inclusion Criteria: 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.

Primary outcome measure(s)

  • Disease Free Survival — 2 years
    Disease Free Survival is defined as the delay between date of inclusion and tumour relapse (local, regional, or distant) or death from any cause, whichever occurs first.

Trial sites (12)

FacilityCityRegionStatus
Institut Bergonie Bordeaux France
Centre Jean Perrin Clermont-Ferrand France
Centre Georges Francois Leclerc Dijon France
Centre Oscar Lambret Lille France
Icm Val D'Aurelle Montpellier France
Centre Azureen de Cancerologie Mougins France
Centre Antoine Lacassagne Nice France
Hopital Saint Louis Paris France
Hôpital Pitie Salpetriere Paris France
Chu Lyon Sud Pierre-Bénite France
INSTITUT de CANCEROLOGIE DE L'OUEST - site René Gauducheau Saint-Herblain France
Gustave Roussy Villejuif France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03697850 on ClinicalTrials.gov ↗ ← All trials in France