InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 19 September 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

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • You have had a certain type of treatment or surgical procedure.

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.

Participating hospitals

Recruiting hospitals

+ Show non-recruiting hospitals

Completed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Know more about Cancer Connect

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Get support

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

More info for carers

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.