Studieninformationen
Kurztitel:
BMS CA209-901 - CheckMate 901
Beschreibung:

A Phase 3, Open-label, Randomized Study of Nivolumab Combined withIpilimumab versus Standard of Care Chemotherapy in Participants with PreviouslyUntreated Unresectable or Metastatic Urothelial Cancer (CheckMate 901:CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 901)

Studiendesign:
Phase III, Therapeutisch, Multizentrisch, International
Therapielinien:
Erstlinie, Metastatic
Alter:
>= 18 Jahre
Ein-/Ausschlusskriterien:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: Disease that is suitable for local therapy administered with curative intent Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways Other protocol-defined inclusion/exclusion criteria apply
NCT-Nummer:
Eudract-Nummer:
Studienaktive Standorte
Rekrutierung läuft
Universitätsklinikum Würzburg
97080 Würzburg
Klinik und Poliklinik für Urologie und Kinderurologie
Herr Prof. Dr. Hubert Kübler
Kuebler_H@ukw.de
Herr Dr. Markus Krebs
Krebs_M@ukw.de