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A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)
A Study of the Safety and Efficacy of Various Combinations of Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder Medley)

NCT05327530

Active Not RecruitingPhase 2

Sponsor: EMD Serono Research & Development Institute, Inc.

Conditions: Locally Advanced or Metastatic Urothelial Carcinoma

Interventions: Avelumab, Sacituzumab Govitecan (SG), M6223, NKTR-255, JB100

Countries: United States, Australia, Belgium, Canada, France, Germany, Greece, Italy

The purpose of this study is to assess the safety and efficacy of avelumab in combination with other anti-tumor agents as a maintenance treatment in participants with bladder cancer.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* 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
Locations (97)
  • Coeur d'Alene, Idaho, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Kansas City, Missouri, United States
  • Seattle, Washington, United States
  • Tacoma, Washington, United States
  • Madison, Wisconsin, United States
  • Bedford Park, Australia
  • Footscray, Australia
  • Kurralta Park, Australia
  • Liverpool, Australia
  • Newcastle, Australia
  • Southport, Australia
  • Sydney, Australia
  • Westmead, Australia
  • Antwerp, Belgium
  • Brasschaat, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Kortrijk, Belgium
  • Libramont, Belgium
  • Liège, Belgium
  • Wuerzburg, Belgium
  • Brampton, Canada
  • Greenfield Park, Canada
  • Montreal, Canada
  • Ottawa, Canada
  • Suresnes, Hauts De Seine, France
  • Angers, France
  • + 67 more on CT.gov