ROSETTA Gastric-204: A Blinded, Randomized, Phase II/III Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Open
Phase: II/III
Principal Investigator: Klute, Kelsey
Contact Information:
Erin Drengler
edrengler@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07221149?term=NCT07221149&viewType=Card&rank=1#participation-criteria
Summary
Primary Objective: To evaluate OR of pumitamig in combination with FOLFOX vs nivolumab + FOLFOX in participants with GC/GEJC/EAC.
Secondary Objectives: -To evaluate the efficacy of pumitamig in combination with FOLFOX vs nivolumab + FOLFOX in participants with GC/GEJC/EAC. -To inform the dose of pumitamig to continue in Phase 3 of the study.
Exploratory Objectives: -To assess the safety and tolerability of pumitamig in combination with FOLFOX vs nivolumab + FOLFOX in participants with GC/GEJC/EAC. -To evaluate potential candidate biomarkers associated with efficacy and safety outcomes. -To evaluate pharmacodynamic effects of pumitamig. -To characterize the PK of pumitamig. -To characterize the IMG of pumitamig.