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

Camille Evrard 1 Christophe Louvet 2 Farid El Hajbi 3, 4 Frédéric Di Fiore 5 Karine Le Malicot 6 Thomas Aparicio 7 Olivier Bouché 8 Pierre Laurent-Puig 9 Frédéric Bibeau 10 Thierry Lecomte 11 Astrid Lièvre 12, 13 Rosine Guimbaud 14 Stefano Kim 15 Aziz Zaanan 16 Harry Sokol 17 Benoist Chibaudel 18 Jérome Desrame 19 Sabrina Pierre 6 Daniel Gonzalez 6 Come Lepage 6 David Tougeron 1, *
* Corresponding author
1 CHU Poitiers - Centre hospitalier universitaire de Poitiers
2 IMM - Institut Mutualiste de Montsouris
3 CHRU Lille - Centre Hospitalier Régional Universitaire [Lille]
4 UNICANCER/Lille - Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille]
5 GPMCND - Génomique et Médecine Personnalisée du Cancer et des Maladies Neuropsychiatriques
6 LNC - Lipides - Nutrition - Cancer [Dijon - U1231]
7 AP-HP - Hopital Saint-Louis [AP-HP]
8 CHU Reims - Centre Hospitalier Universitaire de Reims
9 RTMG - Régulation de la transcription et maladies génétiques
10 CHU Caen
11 CHU Trousseau [Tours]
12 COSS - Chemistry, Oncogenesis, Stress and Signaling
13 CHU Pontchaillou [Rennes]
14 CIC 1436 - CHU de Toulouse/Inserm/UPS - CIC - Toulouse
15 Service de biochimie médicale [CHRU Besançon, hôpital Minjoz]
16 HEGP - Hôpital Européen Georges Pompidou [APHP]
17 CR Saint-Antoine - Centre de Recherche Saint-Antoine
18 Institut hospitalier Franco-Britannique [Levallois-Perret]
19 Hôpital privé Jean Mermoz
Abstract : 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.
Keywords : Adenocarcinoma Chemotherapy Gastric cancer Immune checkpoint inhibitors
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Journal articles
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https://hal.archives-ouvertes.fr/hal-03102304
Contributor : Laurent Jonchère <>
Submitted on : Monday, February 22, 2021 - 2:09:30 PM
Last modification on : Tuesday, February 23, 2021 - 3:44:07 PM

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UNIV-RENNES1 | OSS | UNIV-RENNES | UNIROUEN | SORBONNE-UNIVERSITE | GPMCND | CNRS | LNC-UMR866 | LAMBRET | BIOSIT | U938 | COMUE-NORMANDIE | SU-MEDECINE | UNIV-TLSE3 | MARQUIS | UNIV-BOURGOGNE | FNCLCC | UR1-UFR-SVE | SU-TI | INSERM

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Camille Evrard, Christophe Louvet, Farid El Hajbi, Frédéric Di Fiore, Karine Le Malicot, et al.. PRODIGE 59-DURIGAST trial: A randomised phase II study evaluating FOLFIRI + Durvalumab ± Tremelimumab in second-line of patients with advanced gastric cancer. Digestive and Liver Disease, WB Saunders, 2021, ⟨10.1016/j.dld.2020.11.036⟩. ⟨hal-03102304⟩

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