STUDY DESIGN

JAVELIN Bladder 100 Trial: Study Design1,2
 

Graphic Showing JAVELIN Bladder 100 Regimen With BAVENCIO® (avelumab)

*BSC was administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, and other patient management approaches with palliative intent (excludes systemic antitumor therapy).1

PD-L1 expression was assessed in tumor samples using the VENTANA PD-L1 (SP263) assay.1

CR=complete response; PD-L1=programmed death ligand-1; PR=partial response; SD=stable disease.

JAVELIN BLADDER 100 TRIAL: KEY ELIGIBILITY AND EXCLUSION CRITERIA1,2

Key Eligibility Criteria

  • Unresectable, locally advanced, or metastatic UC
  • ≥1 measurable lesion defined by RECIST v1.1
  • 4-6 cycles of platinum-containing chemotherapy (gemcitabine + cisplatin and/or gemcitabine + carboplatin)
  • ECOG PS 0 or 1

Key Exclusion Criteria

Patients with autoimmune diseases or medical conditions requiring systemic immunosuppression


ECOG PS=Eastern Cooperative Oncology Group (ECOG) Performance Status; RECIST=Response Evaluation Criteria in Solid Tumors.

JAVELIN BLADDER 100 TRIAL: ADDITIONAL STUDY DETAILS

Stratified by best response to chemotherapy (CR/PR vs SD per RECIST v1.1) and site of metastasis (visceral vs non-visceral [including bone metastasis]) assessed at the time of initiating first-line platinum-containing chemotherapy2

  • Administration of BAVENCIO was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator
  • Assessment of tumor status was performed at baseline, 8 weeks after randomization, then every 8 weeks up to 12 months after randomization, and every 12 weeks thereafter until documented confirmed disease progression based on BICR assessment per RECIST v1.1

BICR=blinded independent central review; CR=complete response; PR=partial response; RECIST=Response Evaluation Criteria in Solid Tumors; SD=stable disease.

PATIENT CHARACTERISTICS

Selected Baseline Characteristics of All Randomized Patients in the Study (N=700)1,2
 

*Using the VENTANA PD-L1 (SP263) assay, PD-L1-positive status was defined as PD-L1 expression in ≥25% of tumor cells or in ≥25% or 100% of tumor-associated immune cells if the percentage of immune cells was >1% or ≤1%, respectively. If none of these criteria were met, PD-L1 status was considered negative.1

CR=complete response; ECOG=Eastern Cooperative Oncology Group; PD-L1=programmed death ligand-1; PR=partial response; PS=performance status; SD=stable disease.

View Efficacy and Safety Data

References: 1. Powles T, Park SH, Voog E, et al. Avelumab maintenance therapy for advanced or metastatic urothelial carcinoma. N Engl J Med. 2020;383(13):1218-1230. doi:10.1056/NEJMoa2002788 2. Bavencio. Prescribing information. EMD Serono, Inc.; 2023.