PRODIGE 59-DURIGAST trial: A randomised phase II study evaluating FOLFIRI + Durvalumab ± Tremelimumab in second-line of patients with advanced gastric cancer

• Published in: Digestive and liver disease Vol. 53; no. 4; pp. 420 - 426
• Main Authors: Evrard, Camille, Louvet, Christophe, Hajbi, Farid EL, Fiore, Frédéric DI, Malicot, Karine LE, Aparicio, Thomas, Bouché, Olivier, Laurent-Puig, Pierre, Bibeau, Frédéric, Lecomte, Thierry, Lièvre, Astrid, Guimbaud, Rosine, Kim, Stefano, Zaanan, Aziz, Sokol, Harry, Chibaudel, Benoist, Desrame, Jérome, Pierre, Sabrina, Gonzalez, Daniel, Lepage, Come, Tougeron, David
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01.04.2021; Elsevier
• Subjects: Adenocarcinoma; Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols - pharmacology; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Camptothecin - analogs & derivatives; Cancer; Chemotherapy; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - pathology; Esophagogastric Junction - pathology; Female; Fluorouracil; France; Gastric cancer; Human health and pathology; Humans; Hépatology and Gastroenterology; Immune checkpoint inhibitors; Leucovorin; Life Sciences; Male; Stomach Neoplasms - drug therapy; Stomach Neoplasms - pathology; Treatment Outcome; France; Adenocarcinoma; Chemotherapy; Immune checkpoint inhibitors; Gastric cancer
• ISSN: 1590-8658; 1878-3562
• DOI: 10.1016/j.dld.2020.11.036

Gastric or gastro-oesophageal junction (GEJ) adenocarcinomas present poor overall survival (OS). First-line chemotherapy regimen for patients with HER2-negative tumours is based on a doublet or triplet of fluoropyrimidine plus platinum salt ± taxane. Second-line chemotherapy (Docetaxel or Irinotecan) improves OS which nonetheless remains poor (around 5 months). The first results of immune checkpoint inhibitors (anti-PD-1) combined with chemotherapy in metastatic gastric and GEJ cancers were discordant in recent phase III trials. Data on dual-blockade (anti-PD-L1 or anti-PD-1 plus anti-CTLA-4) plus chemotherapy are lacking. DURIGAST is a randomised, multicenter, non-comparative, phase II study, evaluating safety and efficacy of FOLFIRI plus Durvalumab (anti-PD-L1) versus FOLFIRI plus Durvalumab and Tremelimumab (anti-CTLA-4) as second-line treatment of advanced gastric and GEJ adenocarcinoma. The primary objective is the rate of patients alive and without progression at 4 months. The main inclusion criteria are: patients with advanced gastric or GEJ adenocarcinoma, pre-treated with fluoropyrimidine + platinum salt ± taxane. Due to a lack of data on FOLFIRI, Durvalumab and Tremelimumab combination, a 2-step safety run-in phase has been performed before the randomised phase II. The safety run-in phase did not show any safety issue and the randomised phase II starts in September 2020.