A Phase III, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Tenner, Laura
Contact Information:
Jessica Delaney
jessdelaney@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06901531?term=NCT06901531&rank=1#participation-criteria
Summary
Primary Objectives: To evaluate the efficacy of zolbetuximab plus pembrolizumab and chemotherapy (CAPOX or mFOLFOX6) compared with placebo plus pembrolizumab and chemotherapy (CAPOX or mFOLFOX6) (as first-line treatment).
Secondary Objectives: To evaluate the activity and efficacy of zolbetuximab plus pembrolizumab and chemotherapy compared with placebo plus pembrolizumab and chemotherapy. -To evaluate the efficacy of zolbetuximab plus pembrolizumab and chemotherapy compared with placebo plus pembrolizumab and chemotherapy. -To assess the safety and tolerability of zolbetuximab in combination with pembrolizumab and chemotherapy. -To evaluate the PK of zolbetuximab in combination with pembrolizumab and chemotherapy. -To evaluate the immunogenicity profile of zolbetuximab in combination with pembrolizumab and chemotherapy.
Exploratory Objectives: -To evaluate exploratory biomarkers that may correlate with treatment outcome. -To evaluate HRQoL. -To evaluate PFS following subsequent anticancer therapy (PFS2).