Selective Bladder-Sparing Trial with Sasanlimab as Maintenance Treatment Based On Clinical Response To Neoadjuvant Treatment In Molecularly Categorized Muscle Invasive Bladder Cancer Patients
Patients who sign a written informed consent approved by an IEC for the participation in this trial.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of ≤ 1 within 28 days prior to registration (Appendix 6).
Histological evidence of localized muscle-invasive urothelial cancer of the bladder (i.e., pT2-T4 / N0 / M0). Candidate for cystectomy as per treating physician.
1. Prior treatment with systemic chemotherapy or other approved anticancer treatments for muscle-invasive urothelial cancer of the bladder. Note: In case of prior non muscle-invasive bladder cancer NMIBC, Mitomycin or Bacillus Calmette Guerin (BCG) treatment are allowed.
History of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤6 months prior to start of study treatment.
Congestive heart failure requiring treatment (New York Heart Association Class ≥2).
Uncontrolled hypertension, defined as persistent systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg despite optimal therapy.
Single group
gemcitabine + cisplatine
Drug4 cycles
To evaluate the bladder-intact overall survival at 12 months after the first dose of sasanlimab. Bladder-intact overall survival is defined as the time from initiation of sasanlimab treatment until death or cystectomy
The primary endpoint will be the bladder-intact overall survival rate at 12 months after the first dose of sasanlimab. Bladder-intact overall survival is defined as the time from initiation of sasanlimab treatment until death or cystectomy. The primary endpoint will be the percentage of patients who are alive and with no cystectomy at 12 months after the first dose of sasanlimab.
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Fundación de investigación HM
Lead sponsor
MFAR Clinical Research S.L.
Collaborator
Hospital Universitario 12 de Octubre
Collaborator
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