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ICONIC Trial: Peri-operative Immuno-Chemotherapy in Operable Oesophageal and Gastric Cancer
2016-003306-13Phase 2
Key facts
- Status
- Unknown
- Start
- Mar 2017
- Countries
- 1
- Sponsor
- Royal Marsden NHS Foundation Trust
- Modality
- Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Drugs
- avelumab
- Conditions
- gastric adenocarcinomagastroesophageal junction adenocarcinomaesophageal adenocarcinoma (EAC)
01
Overview
Phase 2, open-label, single-arm trial of avelumab in gastric adenocarcinoma, gastroesophageal junction adenocarcinoma and esophageal adenocarcinoma (EAC), sponsored by Royal Marsden NHS Foundation Trust. Primary endpoint: Maximum administered dose of avelumab in combination with FOLFOX. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Peri-operative avelumab + FOLFOX
Single treatment arm receiving avelumab in combination with FOLFOX chemotherapy before and after curative-intent surgery for operable gastro-oesophageal adenocarcinoma.
03
Who it enrols
Adults with histologically confirmed, operable gastric, gastro-oesophageal junction or oesophageal adenocarcinoma eligible for peri-operative chemotherapy and surgery; key exclusions include uncontrolled active infection, significant comorbidities, and pregnancy.
04
Endpoints
Primary
Maximum administered dose of avelumab in combination with FOLFOX
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