West Cancer Center

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

Site Link

NCT04223856

Malignancy

Bladder Cancer, Urothelial carcinoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

1st Line

Investigational Agent

Enfortumab Vedotin and Pembrolizumab

Drug Class

ADC, PD-1 inhibitor

Dan Vaena, MD

Sponsor

Seattle Genetics, Inc.

Phase

Phase 3

Status

Closed to Accrual

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

Assessment Frequency Link

Path

Transitional cell carcinoma

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes