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

NCT03697850 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: UC-0160/17152018-001807-35
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  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.

  2 years

Secondary Outcomes (11)

• Local control rate

  2 years

• Local control rate

  5 years

• Disease Free Survival

  5 years

• Overall Survival

  2 years

• Overall Survival

  5 years

Study Arms (1)

atezolizumab

EXPERIMENTAL

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.

Drug: Atezolizumab

Interventions

Atezolizumab DRUG

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

atezolizumab

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Complete transurethral resection of bladder tumour (TURBT), either:
• within 6 weeks of selection if no chemotherapy was administered, or before starting chemotherapy.
• Patients for which chemo-radiotherapy is planned
• No major pelvic involvement: pelvic nodes ≤15 mm on CT scan.
• No distant metastasis.
• Patient unfit for radical cystectomy because of age, comorbidities, or patient's refusal.
• Patients ≥18 years old
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Life expectancy ≥12 months.
• 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.
• 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.
• Patients having provided written informed consent prior to any study-related procedures.

You may not qualify if:

• Prior pelvic irradiation.
• MIBC histology other than urothelial or squamous cell carcinomas (e.g., adenocarcinomas, micropapillary, sarcomas, or small cell histological types).
• 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.
• 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.
• Contraindications for pelvic radiotherapy (e.g., inflammatory bowel disease).
• History of immunodeficiency, including HIV infection, or systemic steroid therapy for any other disease.
• A history of active autoimmune disease, except autoimmune-related hypothyroidism and type I diabetes mellitus (see appendix 5).
• History of severe allergic anaphylactic reactions to chimeric, human or humanised antibodies, or fusion proteins.
• Known hypersensitivity to Chinese hamster ovary (CHO) cell products or any component of the atezolizumab formulation.
• Prior allogeneic stem cell or solid organ transplant.
• 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.

Sponsors & Collaborators

• UNICANCER: lead
• Roche Pharma AG: collaborator

Study Sites (12)

Institut Bergonie

Bordeaux, France

Location

Centre Jean Perrin

Clermont-Ferrand, France

Location

Centre Georges Francois Leclerc

Dijon, France

Location

Centre Oscar Lambret

Lille, France

Location

Icm Val D'Aurelle

Montpellier, France

Location

Centre Azureen de Cancerologie

Mougins, 06250, France

Location

Centre Antoine Lacassagne

Nice, France

Location

Hopital Saint Louis

Paris, France

Location

Hôpital Pitie Salpetriere

Paris, France

Location

Chu Lyon Sud

Pierre-Bénite, France

Location

INSTITUT de CANCEROLOGIE DE L'OUEST - site René Gauducheau

Saint-Herblain, France

Location

Gustave Roussy

Villejuif, 94800, France

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Christophe HENNEQUIN, Prof

  Hôpital Saint Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 5, 2018
• Study Start: December 14, 2018
• Primary Completion: June 15, 2025
• Study Completion (Estimated): February 15, 2029
• Last Updated: November 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (12)