MK-3475 vs. paclitaxel, Docetaxel or vinflunine in metastatic urothelial cancer

Update Il y a 4 ans
Reference: EUCTR2014-002009-40

Woman and Man

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Extract

-Evaluate PFS per RECIST 1.1 by blinded independent radiologists’ review of all subjects with recurrent/progressive metastatic urothelial cancer treated with pembrolizumab (MK-3475) compared to paclitaxel, docetaxel or vinflunine. -Evaluate the OS of all subjects with metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy (recurrent/progressive metastatic urothelial cancer), when treated with MK-3475 compared to paclitaxel, docetaxel or vinflunine. -Evaluate the PFS per RECIST 1.1 by blinded independent radiologists’ review of subjects with platinum-refractory recurrent/progressive metastatic PD-L1 positive urothelial cancer treated with MK-3475 compared to paclitaxel, docetaxel or vinflunine. -Evaluate the OS of subjects with platinum-refractory metastatic or locally advanced/unresectable PD-L1 positive urothelial cancer, when treated with MK-3475 compared to paclitaxel, docetaxel or vinflunine.


Inclusion criteria

  • Metastatic or locally advanced/unresectable urothelial cancer that has recurred or progressed following platinum-based chemotherapy