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

  • STATUS
    Recruiting
  • End date
    Feb 15, 2027
  • participants needed
    77
  • sponsor
    UNICANCER
Updated on 22 June 2021
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 urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder, bladder tumor
Treatment Atezolizumab
Clinical Study IdentifierNCT03697850
SponsorUNICANCER
Last Modified on22 June 2021

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/mm Platelet count 100000 cells/mm 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)
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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