Back to Clinical Trials

Brief Title: Avelumab as Therapy in Locally Advanced or Metastatic Urothelial Carcinoma (JAVELIN Bladder 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)


  • Org Study ID: MS100070_0119
  • Secondary ID: N/A
  • NCT ID: NCT05327530
  • Sponsor: EMD Serono Research & Development Institute, Inc.


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.

  • Overall Status
  • Start Date
    August 17, 2022
  • Phase
    Phase 2
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • Locally Advanced or Metastatic Urothelial Carcinoma


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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Medical Responsible

Role: Study Director

Affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Overall Contact

Name: US Medical Information, Communication Center

Phone: 888-275-7376, +49 6151 72 5200



Facility Status Contact
Facility: University of Kansas Medical Center Research Institute, Inc. - 3901 Rainbow (MAIN)
Kansas City, Kansas 66205
United States
Status: Recruiting Contact: Contact

Principal Investigator
Saqib Abbasi

Facility: Johns Hopkins University
Baltimore, Maryland 21287-7049
United States
Status: Recruiting Contact: Principal Investigator
Jean Hoffman Censits

Facility: AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company - Kansas City, MO at St. Joseph Medical Center
Kansas City, Missouri 66204
United States
Status: Recruiting Contact: Contact

Principal Investigator
Jaswinder J Singh

Facility: Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact

Principal Investigator
Petros Grivas

Facility: Multicare Health System Tacoma General Hospital
Tacoma, Washington 98405
United States
Status: Recruiting Contact: Contact

Principal Investigator
Sunil Rangarajan

Facility: University of Wisconsin Cancer Center
Madison, Wisconsin 53706
United States
Status: Recruiting Contact: Contact

Principal Investigator
Christos Kyriakopoulos