BLADDER: METASTATIC: 1st LINE: ENFORTUMAB VEDOTIN: SGN22E-003

An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy, versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer 

Title
Seattle Genetics SGN22E-003 (Bladder, enfortumab vedotin)
Study Title

An open-label, randomized, controlled phase 3 study of enfortumab vedotin in combination with pembrolizumab with or without chemotherapy, versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer 

Site Link
Malignancy
Bladder Cancer, Urothelial carcinoma
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
Enfortumab Vedotin and Pembrolizumab
Drug Class
ADC, PD-1 inhibitor
PI
Dan Vaena, MD
Sponsor
Seattle Genetics, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Unresectable locally advanced or metastatic urothelial carcinoma
  • Measurable disease
  • No prior systemic therapy for metastatic urothelial carcinoma with following exceptions
    • May have received neoadjuvant chemo with recurrence >12 months from completion of therapy
    • May have received adjuvant chemo with recurrence >12 months from completion of therapy
  • Must be eligible to receive platinum based chemotherapy
  • ECOG PS 0-2
  • No CNS metastases
  • No known HBV, HCV, or HIV
  • No other malignancy within 3 years before study drug
Objective
  • Primary
    • PFS
    • OS
  • Secondary
    • Duration of PFS
    • ORR
    • ORR by investigator assessment
    • DOR
    • DCR
    • PROs
    • Safety
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
Transitional cell carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
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