MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer

Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI); durvalum...

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Published in:Future oncology (London, England) Vol. 18; no. 20; p. 2465
Main Authors: Janjigian, Yelena Y, Van Cutsem, Eric, Muro, Kei, Wainberg, Zev, Al-Batran, Salah-Eddin, Hyung, Woo Jin, Molena, Daniela, Marcovitz, Michelle, Ruscica, Dario, Robbins, Scott H, Negro, Alejandra, Tabernero, Josep
Format: Journal Article
Language:English
Published: England 01.06.2022
Subjects:
Adenocarcinoma - pathology
Antibodies, Monoclonal
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Clinical Trials, Phase III as Topic
Esophagogastric Junction - pathology
Fluorouracil - adverse effects
Humans
Neoadjuvant Therapy
Randomized Controlled Trials as Topic
Stomach Neoplasms - pathology
neoadjuvant-adjuvant
resectable
durvalumab
gastric cancer
immunotherapy
PD-L1
gastroesophageal junction cancer
immune checkpoint inhibitors
chemotherapy
ISSN:1744-8301, 1744-8301
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Summary:Standard-of-care for resectable gastric/gastroesophageal junction cancer includes surgery and neoadjuvant-adjuvant 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) chemotherapy. Early-phase clinical studies support further clinical development of the immune checkpoint inhibitor (ICI); durvalumab, an anti-PD-L1 antibody, in patients with gastric/gastroesophageal junction cancer. Accumulating evidence indicates that ICIs combined with FLOT chemotherapy improve clinical outcomes in patients with advanced or metastatic cancer. We describe the rationale for and the design of MATTERHORN, a randomized, double-blind, placebo-controlled, phase III study investigating the efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy followed by adjuvant durvalumab monotherapy in patients with resectable gastric/gastroesophageal junction cancer. The planned sample size is 900 patients, the primary end point is event-free survival and safety and tolerability will be evaluated. Clinical trial registration: NCT04592913 (ClinicalTrials.gov).
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ISSN:1744-8301
1744-8301
DOI:10.2217/fon-2022-0093