<HashMap><database>biostudies-literature</database><scores/><additional><omics_type>Unknown</omics_type><volume>17(1)</volume><submitter>Lorenzen S</submitter><pubmed_abstract>This multi-cohort study evaluates whether dual immune checkpoint inhibition with nivolumab and ipilimumab in parallel or sequentially, or triplet chemotherapy with nivolumab can enhance efficacy as first-line therapy for advanced or metastatic gastroesophageal adenocarcinoma. Patients are randomized 1:1 to Arm A (mFOLFOX + nivolumab 240 mg every two weeks + ipilimumab 1 mg/kg every six weeks in parallel or Arm B (mFOLFOX). Subsequently, patients are randomized 1:2 to Arm A1 (identical to Arm A) or Arm A2 (three cycles of mFOLFOX followed by nivolumab + ipilimumab). In Arm C all patients receive FLOT + nivolumab. Primary endpoint is progression-free survival. Secondary endpoints include overall survival and objective response rate. Median progression-free survival (months) is: Arm A/A1, 5.8</pubmed_abstract><journal>Nature communications</journal><pagination>2072</pagination><full_dataset_link>https://www.ebi.ac.uk/biostudies/studies/S-EPMC12948978</full_dataset_link><repository>biostudies-literature</repository><pubmed_title>First-line modified FOLFOX plus/minus nivolumab and Ipilimumab or FLOT plus nivolumab in advanced gastroesophageal adenocarcinoma: a phase II multi-cohort trial.</pubmed_title><pmcid>PMC12948978</pmcid><pubmed_authors>Angermeier S</pubmed_authors><pubmed_authors>Luley KB</pubmed_authors><pubmed_authors>Pink D</pubmed_authors><pubmed_authors>Thuss-Patience PC</pubmed_authors><pubmed_authors>Junge S</pubmed_authors><pubmed_authors>Goekkurt E</pubmed_authors><pubmed_authors>Hofheinz RD</pubmed_authors><pubmed_authors>Schuch G</pubmed_authors><pubmed_authors>Lindig U</pubmed_authors><pubmed_authors>Lorenzen S</pubmed_authors><pubmed_authors>Folprecht G</pubmed_authors><pubmed_authors>Goetze TO</pubmed_authors><pubmed_authors>Riera-Knorrenschild J</pubmed_authors><pubmed_authors>Bitzer M</pubmed_authors><pubmed_authors>Heinemann V</pubmed_authors><pubmed_authors>Bolling C</pubmed_authors><pubmed_authors>Ettrich TJ</pubmed_authors><pubmed_authors>Pauligk C</pubmed_authors><pubmed_authors>Dechow TN</pubmed_authors><pubmed_authors>Al-Batran SE</pubmed_authors><pubmed_authors>Loose M</pubmed_authors></additional><is_claimable>false</is_claimable><name>First-line modified FOLFOX plus/minus nivolumab and Ipilimumab or FLOT plus nivolumab in advanced gastroesophageal adenocarcinoma: a phase II multi-cohort trial.</name><description>This multi-cohort study evaluates whether dual immune checkpoint inhibition with nivolumab and ipilimumab in parallel or sequentially, or triplet chemotherapy with nivolumab can enhance efficacy as first-line therapy for advanced or metastatic gastroesophageal adenocarcinoma. Patients are randomized 1:1 to Arm A (mFOLFOX + nivolumab 240 mg every two weeks + ipilimumab 1 mg/kg every six weeks in parallel or Arm B (mFOLFOX). Subsequently, patients are randomized 1:2 to Arm A1 (identical to Arm A) or Arm A2 (three cycles of mFOLFOX followed by nivolumab + ipilimumab). In Arm C all patients receive FLOT + nivolumab. Primary endpoint is progression-free survival. Secondary endpoints include overall survival and objective response rate. Median progression-free survival (months) is: Arm A/A1, 5.8</description><dates><release>2026-01-01T00:00:00Z</release><publication>2026 Feb</publication><modification>2026-07-16T23:26:23.362Z</modification><creation>2026-07-12T03:11:28.987Z</creation></dates><accession>S-EPMC12948978</accession><cross_references><pubmed>41760643</pubmed><doi>10.1038/s41467-026-69622-7</doi></cross_references></HashMap>