Klinische Studie

Krankheitsentität(en) Harnblase, Harnleiter, Niere
StudientypInterventionsstudiePhase III
Wesentliche Einschlusskriterien1. Histologically or cytologically documented muscle-invasive TCC of the bladder with clinical stage of T2-4aN0-N1M0 (AJCC Cancer Staging Manual, 8th Edition). Transitional and mixed transitional/non-transitional/variant cell histologies are accepted 2. Medically fit for cystectomy and able to receive neoadjuvant therapy 3. ECOG performance status of 0 to 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing. 4. Provision of the most recent tissue sample from MIBC to assess the PD-L1 status/expression prior to randomization. 5. Cisplatin-ineligible
Wesentliche Ausschlusskriterien1. Evidence of multiple lymph node (N2+) or metastatic TCC/UC, extravesical TCC/UC that invades the pelvic and/or abdominal wall for bladder cancer (T4b), or primary non-bladder (ie, ureter, urethral, or renal pelvis) TCC/UC of the urothelium. 2. Nephroureterectomy required per investigator at the time of randomization for tumor of the mid ureter, renal pelvis, or collecting system. 3. Ureterectomy required if a ureteral tumor is present proximal to common iliacs in addition to planned cystectomy. 4. History of allogeneic organ transplantation that requires use of immunosuppressive agents. Participants with a history of allogenic stem cell transplantation are also excluded. 5. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], autoimmune pneumonitis, autoimmune myocarditis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]).
Ansprechpartner & KontaktCaritas-Krankenhaus St. Josef RegensburgUrologieStudienzentrale0941 7823506uro-studienzentrum(at)csj.de