Clinical Trial

Phase II Study of Avelumab Plus Chemotherapy in the Peri-operative Treatment for Patients With Resectable Gastric Cancer (GC) or Gastroesophageal Junction Cancer (GEJC)

Study acronym: MONEO
Active, Not Recruiting Phase 2
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Summary
Phase II Study of Avelumab plus chemotherapy in the peri-operative treatment for patients with resectable Gastric cancer (GC) or Gastroesphageal Junction cancer (GEJC) The addition of Avelumab to the perioperative chemotherapy in GC and GEJC patients may increase pathological responses by a synergic effect activating the immune response. Conclusively, the survival of these patients would improve. The primary objective is to investigate whether the addition of avelumab to FLOT chemotherapy (docetaxel, oxaliplatin and fluorouracil/leucovorin) improves efficacy in terms of pathological complete response (pCR) rate, in GC and GEJC patients compared to the historical data of chemotherapy alone in the neoadjuvant setting.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2019-06-06; most recent amendment 2024-11-06.
Status change: Recruiting → Active, Not Recruiting 2023-04-25
Status change: Not Yet Recruiting → Recruiting 2019-09-30
Trial Details
NCT Number NCT03979131
Lead Sponsor Vall d'Hebron Institute of Oncology
Conditions Gastroesophageal Junction Adenocarcinoma, Stomach Neoplasms
Enrollment 40 participants
Start Date 2019-08-22
Primary Completion 2023-03-15 (estimated)
Study Completion 2026-06-15 (estimated)
Updated on ClinicalTrials.gov 2024-11-07