Liposomal irinotecan, carboplatin or oxaliplatin (LyRICX) with or without nivolumab in the first-line treatment of metastatic or irresectable esophagogastric adenocarcinoma: A randomized phase 2 study.

LBA287 Background: Oxaliplatin-based regimens are standard of care for metastatic/irresectable esophagogastric cancer, but can cause substantial neurotoxicity, limiting quality of life and eligibility for subsequent therapies. This study aims to identify the most favorable first-line chemotherapy backbone, balancing efficacy and neurotoxicity. Methods: This multi-center, open label, randomized phase II clinical trial enrolled adults with previously untreated pathologically confirmed metastatic/irresectable HER2 negative esophagogastric adenocarcinoma from 31 medical centers in the Netherlands. Until August 2022, patients were randomized (2:2:1) to one of three arms: 1) nanoliposomal irinotecan, leucovorin and fluorouracil (F-Nal-Iri); 2) capecitabine and carboplatin (CapCar); 3) capecitabine and oxaliplatin (CapOx). Following approval of nivolumab, patients with Combined Positive Score (CPS)