MONEO: A phase II study of avelumab (Av) plus FLOT in the peri-operative treatment for patients (pts) with resectable gastric or gastroesophageal junction cancer (GC).

Authors

MARIA ALSINA

MARIA ALSINA

Vall d'Hebron Institute of Oncology, Barcelona, Spain

MARIA ALSINA , Mariano Ponz-Sarvise , Dario Lopez Garcia , Marta Gonzalez , Carlos E De Andrea , Alena Gros , Ana Vivancos , Paula Jiménez-Fonseca , Marc Diez Garcia , Virginia Arrazubi , Enrique Sanz-Garcia , Eva Martínez de Castro , Raquel Guardeno , Mariona Calvo , Cristina Buges , Federico Longo , Josep Tabernero , Guillermo Villacampa , Susana Muñoz , Ignacio Melero

Organizations

Vall d'Hebron Institute of Oncology, Barcelona, Spain, Department of Medical Oncology, Gastrointestinal Oncology Unit, Clínica Universidad de Navarra, University of Navarra, Pamplona, Spain, Vall d' Hebron Institute of Oncology, Barcelona, Spain, Clínica Universidad de Navarra, University of Navarra, Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Pamplona, Spain, Tumor Immunology and Immunotherapy, Vall d’Hebron Institute of Oncology (VHIO), Vall d’Hebron University Hospital, Cellex Center, Barcelona, Spain, Cancer Genomics, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, Hospital Universitario Central de Asturias, Oviedo, Spain, Vall d´Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain, Service of Medical Oncology, Complejo Hospitalario de Navarra, Pamplona, Spain, HM Sanchinarro Centro Integral Oncológico Clara Campal, Madrid, Spain, H. Universitario Marqués de Valdecilla, Santander, Spain, Institut Catala d'Oncologia, Hospital Josep Trueta, Girona, Spain, UTEG, Institut Català d'Oncologia, IDIBELL, Barcelona, Spain, Hospital Germans Trias i Pujol, Badalona, Institut Català d'Oncologia (ICO), Barcelona, Spain, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria (IRICYS), CIBERONC, Madrid, Spain, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Oncology (VHIO), UVic-UCC, Barcelona, Spain, Oncology Data Science Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain, Universidad de Navarra, Center for Applied Medical Research (CIMA), Pamplona, Spain

Research Funding

Pharmaceutical/Biotech Company
Merck

Background: GC represents a worldwide problem; radical surgery remaining the gold standard of curative treatment. In the West, even with peri-operative chemotherapy, 5-year survival rate is approximately 40%. GC is a heterogeneous disease, well characterized by different molecular classifications, all having in common the role of the immune system and a T-cell inflamed phenotype across all subtypes. The anti-PD-L1 Av antibody has demonstrated efficacy in GC with response rates of around 10% in the refractory setting. The addition of other immune checkpoint inhibitors to chemotherapy have demonstrated efficacy in the metastatic setting. The combination of Av to perioperative chemotherapy may increase pathological responses by a synergistic effect, and then improving the survival (OS). Methods: The MONEO is an open-label, non-randomized, multicentric, phase II study that explores the combination of Av plus peri-operative FLOT (docetaxel, oxaliplatin, fluorouracil/leucovorin) in resectable GC pts. EudraCT 2019-000782-21; ClinicalTrials NCT03979131. Main inclusion criteria require pts with histologically proven GC, stage Ib (T1N1 only) - IIIC (7th AJCC Ed), available paraffin block from diagnosis and surgery, evaluable disease (RECIST 1.1) amenable to radical surgery. Significant comorbidities and active autoimmune diseases are excluded. Treatment consists of surgery with 4 peri-operatory cycles of FLOT + Av, followed by Av up to one year. The primary objective is the pathological complete response (pCR) rate, compared to historical data. Secondary objectives include OS, disease-free survival, R0 resection rate, tolerability and biomarker analysis. Key point is the comprehensive biomarker analysis from tissue and blood samples (pathological immune response, TCR clonality, immune contexture characterization, immunodynamic monitoring). Statistics for an estimated 33% pCR (historical 16%), 82% power, 0.1 one-side type I error. 37 pts will be recruited from 10 Spanish centers. The sponsor is Vall d'Hebron Institute of Oncology (VHIO), principal investigators Dr. Melero and Dr. Alsina. In compliance with the Helsinki Declaration. At a data cut-off day of 5th of February 2021, 38 patients have been enrolled, 27 of them have had the surgery. Although the difficulties during the COVID19 pandemia, only two patients had been withdrawn from the study. Clinical trial information: NCT03979131

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT03979131

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr TPS4155)

DOI

10.1200/JCO.2021.39.15_suppl.TPS4155

Abstract #

TPS4155

Poster Bd #

Online Only

Abstract Disclosures

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