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Bladder CancerPhase 2BladderSparNCT03697850

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

A Phase 2 study testing Atezolizumab in people with Bladder Cancer, run by UNICANCER at 12 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Bladder Cancer
What is being tested?
Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
12 sitesFrance
Study dates
14 Dec 2018to 15 Feb 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Patients affiliated to the social security scheme.
  • Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
  • 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.
  • Patients who have received standard (chemo)-radiotherapy ≥60 gray (Gy) or equivalent on the bladder according to the local practice.
  • The first administration of atezolizumab must be performed 30 (+/-5) days after the last session of radiotherapy (RT).
  • ECOG performance status ≤2.
  • 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.
  • 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.
  • Patients having provided written informed consent prior to any study-related procedures.
  • Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
  • 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.

Who cannot join

  • 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.
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  • 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.
  • Patients with any other disease or illness which requires hospitalisation or is incompatible with the study treatment are not eligible.
  • 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.
  • Patients enrolled in another therapeutic study within 30 days of selection.
  • Pregnant or breast feeding women.
  • Person deprived of their liberty or under protective custody or guardianship.
  • The same non-inclusion criteria of the selection phase have to be respected.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

France12 sites

  • Institut Bergonie

    Bordeaux

  • Centre Jean Perrin

    Clermont-Ferrand

  • Centre Georges Francois Leclerc

    Dijon

  • Centre Oscar Lambret

    Lille

  • Icm Val D'Aurelle

    Montpellier

  • Centre Azureen de Cancerologie

    Mougins, 06250

  • Centre Antoine Lacassagne

    Nice

  • Hopital Saint Louis

    Paris

  • Hôpital Pitie Salpetriere

    Paris

  • Chu Lyon Sud

    Pierre-Bénite

  • INSTITUT de CANCEROLOGIE DE L'OUEST - site René Gauducheau

    Saint-Herblain

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: Phase II Study of Maintenance Anti-PD-L1 Treatment With Atezolizumab After Chemo-radiotherapy for Muscle-infiltrating Bladder Cancer Patients Not Eligible for Radical Cystectomy: Bladder Sparing

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
Being tested
Atezolizumab
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

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

Study groups in NCT03697850
Study groupRoleWhat they receive
atezolizumabExperimentalAnti-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.
Receives: Drug: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (11)

  1. Local control rate

    Local control rate will be evaluated by cystoscopy. The presence of non-muscle-invasive or muscle-invasive bladder cancers will be considered as a local failure. To be defined as locally controlled, the bladder must be completely free of tumour.

    Measured: 2 years

  2. Local control rate

    Local control rate will be evaluated by cystoscopy. The presence of non-muscle-invasive or muscle-invasive bladder cancers will be considered as a local failure. To be defined as locally controlled, the bladder must be completely free of tumour.

    Measured: 5 years

  3. 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.

    Measured: 5 years

  4. Overall Survival

    Overall Survival is defined as the delay between the date of inclusion and the date of death, from any cause.

    Measured: 2 years

  5. Overall Survival

    Overall Survival is defined as the delay between the date of inclusion and the date of death, from any cause.

    Measured: 5 years

  6. Incidence of Treatment-Emergent Adverse Events

    The tolerance and safety will be evaluated by toxicity (acute [<6 months after the start of atezolizumab] and late [≥6 months after the start of atezolizumab]), assessed using the NCI CTCAE v5.0

    Measured: 2 years

  7. Incidence of Treatment-Emergent Adverse Events

    The tolerance and safety will be evaluated by toxicity (acute [<6 months after the start of atezolizumab] and late [≥6 months after the start of atezolizumab]), assessed using the NCI CTCAE v5.0

    Measured: 5 years

  8. Quality of Life Core Questionnaire - Cancer Patients (QLQ-C30)

    Quality of life

    Measured: 5 years

  9. Quality of Life Core Questionnaire - Bladder Cancer Muscle Invasive (QLQ-BLM30)

    Quality of Life

    Measured: 5 years

  10. Quality of Life Core Questionnaire - Elderly Cancer Patients (QLQ-ELD14)

    Quality of Life

    Measured: 5 years

  11. G8 oncodage

    Quality of Life

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2018
  2. Study start14 Dec 2018
  3. Primary completion15 Jun 2025
  4. Study completion15 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03697850
Sponsor's protocol ID
UC-0160/1715
Other IDs
2018-001807-35, 2018
Acronym
BladderSpar
Status last verified
Dec 2024
First submitted
2 Oct 2018
Last updated
18 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Bladder Cancer, run by UNICANCER at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03697850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.

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