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RecruitingLast updated:15 August 2023

Javelin Medley: This trial will determine how safe and effective Avelumab (an immunotherapy) is as a maintenance treatment for people with advanced urothelial carcinoma who showed no progression following first-line chemotherapy treatmentA 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)

Clinical summary

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.

Age

People18+

Phase

II

Trial Acronym

Javelin Medley

More information

Trial Identifiers

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Commercial Sponsor

EMD Serono

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)

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

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