A Randomized, Phase III Study of Rilvegostomig in Combination with Fluoropyrimidine and Trastuzumab Deruxtecan versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First-line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, GI (ONC)
Current Status: Open
Phase: III
Principal Investigator: Krishnan, Mridula
Contact Information:
Erin Drengler
edrengler@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT06764875?term=NCT06764875&rank=1#participation-criteria
Summary
Primary Objectives:
-To evaluate the efficacy of rilvegostomig in combination with fluoropyrimidine and T-DXd compared to trastuzumab, chemotherapy, and pembrolizumab, as measured by PFS.
-To evaluate the efficacy of rilvegostomig in combination with fluoropyrimidine and T-DXd compared to trastuzumab, chemotherapy, and
pembrolizumab, as measured by OS.
Secondary Objectives:
-To evaluate the efficacy of rilvegostomig in combination with trastuzumab and chemotherapy compared to trastuzumab, chemotherapy, and pembrolizumab, as measured by PFS.
-To evaluate the efficacy of rilvegostomig in combination with trastuzumab and chemotherapy compared to trastuzumab, chemotherapy, and
pembrolizumab, as measured by OS.
-To further evaluate the efficacy of rilvegostomig in combination with fluoropyrimidine and T-DXd, and rilvegostomig in combination with trastuzumab and chemotherapy, compared to trastuzumab, chemotherapy, and pembrolizumab.
-To evaluate the efficacy of rilvegostomig in combination with fluoropyrimidine and T-DXd compared to rilvegostomig in combination with trastuzumab and chemotherapy.
-To assess the safety and tolerability of rilvegostomig in combination with fluoropyrimidine and T-DXd, and rilvegostomig in combination with trastuzumab and chemotherapy, compared to trastuzumab, chemotherapy, and pembrolizumab.
-To assess the PK of rilvegostomig, T-DXd, total anti-HER2 antibody, DXd in serum, 5-FU and capecitabine in plasma.
-To investigate the immunogenicity of rilvegostomig and T-DXd. -To evaluate the efficacy of rilvegostomig in combination with fluoropyrimidine and T-DXd, and rilvegostomig in combination with trastuzumab and chemotherapy, compared to trastuzumab, chemotherapy, and pembrolizumab, based on an increase in enteral feeding assistance and eating difficulties.
-To assess the tolerability of rilvegostomig in combination with fluoropyrimidine and T-DXd, and rilvegostomig in combination with trastuzumab and chemotherapy, compared to trastuzumab, chemotherapy, and pembrolizumab by assessment of the proportion of time on study intervention with high side-effect bother. -To assess participant-reported PF in participants treated with rilvegostomig in combination with fluoropyrimidine and T-DXd, and rilvegostomig in combination with trastuzumab and chemotherapy, compared to trastuzumab, chemotherapy, and pembrolizumab.