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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)

INTRODUCTION

  • Org Study ID: MS100070_0119
  • Secondary ID: 2021-003669-36
  • NTC ID: NCT05327530
  • Sponsor: EMD Serono Research & Development Institute, Inc.
Trial Awareness and Transparency website, US Medical Information website, Medical Resources

BRIEF SUMMARY

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
    Recruiting
  • Start Date
    August 15, 2022
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

Primary Outcome 1 - Timeframe: Time from randomization of study drug until first documentation of progressive disease (PD) or death, assessed approximately up to 51 months

Primary Outcome 2 - Measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events, and AEs of Special Interest (AESIs) as per Qualitative Toxicity Scale [National Cancer Institute-Common Terminology Criteria for Adverse Events 5.0]

Primary Outcome 2 - Timeframe: Randomization up to the last safety follow-up visit at approximately up to 51 months

CONDITION

  • Locally Advanced or Metastatic Urothelial Carcinoma

ELIGIBILITY

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, any other antibody or drug specifically targeting T cell costimulation or immune checkpoint pathways, 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) and replication-deficient coronavirus vaccines approved or authorized by local Health Authorities

- Other protocol defined exclusion criteria could apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Responsible

Role: Study Director

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

Overall Contact

Name: Medical Responsible

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

Email: eMediUSA@emdserono.com, service@emdgroup.com

LOCATION

Facility Status Contact
Facility: Beacon Cancer Care
Coeur d'Alene, Idaho 83814
United States
Status: Recruiting Contact: N/A
Facility: Multicare Health System Tacoma General Hospital
Tacoma, Washington 98405
United States
Status: Recruiting Contact: N/A