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

  • STATUS
    Recruiting
  • End date
    Feb 15, 2029
  • participants needed
    77
  • sponsor
    UNICANCER
Updated on 4 October 2022
radical cystectomy
cancer
white blood cell count
metastasis
bladder cancer
invasive bladder cancer
transurethral resection
atezolizumab
bladder tumor
transurethral bladder excision

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.

Details
Condition Bladder Cancer
Treatment Atezolizumab
Clinical Study IdentifierNCT03697850
SponsorUNICANCER
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

The same non-inclusion criteria of the selection phase have to be respected
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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