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RecruitingLast updated: 1 March 2024

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.

Conditions

This trial is treating patients with urothelial cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

Javelin Medley

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Trial Identifiers

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Trial 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

  • Participants with histologically confirmed, 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
  • Participants has documented Stage IIIA/IIIB with N1-N3, or Stage IV disease (per American Joint Committee on Cancer/International Union for Cancer Control Tumor Node Metastasis system, 8th edition) at the start of first line chemotherapy.
  • The last dose of first line chemotherapy must have been received no less than 4 weeks, and no more than 10 weeks, prior to randomization in the present study
  • Estimated life expectancy of at least 3 months
  • Participants without progressive disease as per RECIST v1.1 guidelines following completion of 4 to 6 cycles of 1L chemotherapy. Eligibility based on this criterion will be determined by Investigator review of pre chemotherapy and post chemotherapy radiological assessments (CT/MRI scans).
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Adequate hematological, hepatic, and renal function as defined in the protocol
  • Other protocol defined inclusion criteria could apply

Exclusion

  • Participants with prior immunotherapy with Interleukin-2 (IL-2), IL-15, interferon alfa (IFN-α), or an anti programmed death receptor-1 (PD-1), anti programmed death-ligand 1 (PD-L1), anti PD-L2, anti CD137, or cytotoxic T cell lymphocyte-4 (CTLA-4) antibody (including ipilimumab), anti TROP2, anti-T-cell-immuno-receptor with Ig and ITM domains (anti-TIGIT) any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways, agents targeting Nectin-4, or any of the investigational drugs used in combination with avelumab.
  • Participants with active infection 48 hours before randomization requiring systemic therapy
  • Participants with known prior or suspected hypersensitivity to study drugs or any component in their formulations
  • Participants with prior adjuvant or neoadjuvant systemic therapy within 12 months of randomization
  • Participants with vaccination within 4 weeks of the first dose of study treatment and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines) administered >= 2 weeks prior first dose of study treatment. All severe acute respiratory syndrome coronavirus (SARS-CoV-2) vaccines approved or authorized by local Health Authorities are allowed
  • Other protocol defined exclusion criteria could apply

Inclusion

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

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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