Javelin Medley : A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor 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 (JAVELIN Bladder Medley)

Trial Identifiers

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• NCT05327530
• MS100070_0119

Scientific Title

A Phase II, Multicenter, Randomized, Open Label, Parallel-Arm, Umbrella Study of Avelumab (MSB0010718C) in Combination With Other AntiTumor 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 (JAVELIN Bladder Medley)

Commercial Sponsor

EMD Serono

Summary

Eligible participants will be randomised into one of four groups (A-D). Participants in Group A will receive 800mg of intravenous Avelumab once every two weeks, until toxicity, consent or initiation of new treatment. Participants in Groups B-D will receive Avelumab in combination with sacituzumab govitecan, M6223 or NKTR-255. Sacituzumab govitecan will be administered intravenously, at a dose of 10mg/kg of body weiht once a week on Day 1 and 8 of a 21-day treatment cycle; M6223 (an anti-T cell-immuno-receptor with Ig and ITM domains) will be administered at a dose of 1600mg once every two weeks, intravenously; and NKTR-255 will be administered intravenously at a dose of 3 micrograms per kilogram of body weight once every four weeks.