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

NCT ID: NCT03697850

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-14
• Study Completion Date: 2029-02-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Atezolizumab

Intervention Type: DRUG

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

Interventions

Atezolizumab

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

Intervention Type: DRUG

Eligibility Criteria

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.

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe HENNEQUIN, Prof

Role: PRINCIPAL_INVESTIGATOR

Hôpital Saint Louis

Locations

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

Countries

France

Other Identifiers

2018-001807-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UC-0160/1715

Identifier Type: -

Identifier Source: org_study_id