Title
ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 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

Description
ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 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

Objective
Phase 2:
Primary - To evaluate OR of pumitamig in combination with FOLFOX vs nivolumab + FOLFOX in participants with GC/GEJC/EAC

Secondary
-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

Phase 3:
Primary
-compare PFS of pumitamig in combination with chemotherapy vs nivolumab in combination with chemotherapy in participants with
GC/GEJC/EAC
-To compare OS of pumitamig in combination with chemotherapy vs nivolumab in combination with chemotherapy in participants with GC/GEJC/EAC

Secondary
-To evaluate the efficacy of pumitamig in combination with chemotherapy vs nivolumab in combination with chemotherapy in participants
with GC/GEJC/EAC

Treatment The purpose of this study is to evaluate the safety and efficacy 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

Key Eligibility Inclusion Criteria

-Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.
-Participants must have a documented programmed cell death-(ligand)1 (PD-L1) >/= 1 or < 1 status for Phase 2, and document PD-L1 >/= 1 status for the Phase 3 part of the study.
-Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.
-Participants must have measurable disease as defined by RECIST v1.1.

Applicable Disease Sites
Esophagus; Stomach

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital