Clinical Trial

A Phase 2/3 Interventional Study Of PF-08634404 In Combination With Chemotherapy In Treatment-Naïve Participants With Locally Advanced Or Metastatic Gastric, Gastroesophageal Junction, Or Esophageal Adenocarcinoma

MOA: PF-08634404 is a recombinant anti-PD-1 and anti-VEGF human mAb

Key Eligibility Criteria:

• Histologically or cytologically confirmed gastric, GEJ, or EAC that is locally advanced unresectable or metastatic
• No prior systemic therapy for advanced or metastatic disease
  • Subjects who received neo/adjuvant therapy or chemoradiation and recur
    or develop metastatic disease within 6mo of stopping treatment will count
    as having prior therapy and are not eligible
• Subjects should have PD-L1 tumor expression (TAP ≥1% or CPS ≥1)
  and HER2-negative status based on local testing results
• Squamous cell or undifferentiated gastroesophageal cancer are
  excluded
• Subjects with prior exposure to anti-VEGF therapy or cancer
  immunotherapy are excluded
  • Prior treatment with an approved PD-1/PD-L1 inhibitor in the peri
    operative setting is allowed if the treatment was completed > 9 months
    prior to enrollment