Protocol Title: A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination with Other Anti-Tumor Agents as a Maintenance Treatment in Participants with Locally Advanced or Metastatic Urothelial Carcinoma Whose Disease Did Not Progress with First Line Platinum-Containing Chemotherapy

Sponsor: EMD Serono

Protocol Number: MS100070-0119 “JAVELIN”

Key Criteria

Unresectable Locally Advanced or Metastatic Urothelial Carcinoma
  • Both transitional cell and mixed transitional/non-transitional cell histologies are allowed, but transitional cell carcinoma must be the predominant histology
  • Documented Stage IIA/IIIB with N1-N3 or Stage IV disease at the start of the first line chemotherapy
  • Prior 1L chemotherapy must have consisted of at least 4 cycles and no more than 6 cycles of gemcitabine + cisplatin and/or gemcitabine + carboplatin. No other chemotherapy regimens are allowed in this study
  • Last dose of first line chemotherapy must have been received no less than 4 weeks, and no more than 10 weeks, prior to randomization 
  • Without progressive disease as per RECIST v1.1 guidelines following completion of 1L chemotherapy

Talking Points

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