Clinical Trial

Simvastatin Efficacy in ARID1A Mutated Advanced gastroESophageal Carcinoma Treated With Immunotherapy

Recruiting Phase 2
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Summary
The investigators hypothesize that simvastatin (SIM) may improve the efficacy of first- line Nivolumab and Oxaliplatin-based chemotherapy, extending progression-free survival (PFS) as compared with Nivolumab and chemotherapy alone in patients with HER2 negative and ARID1A mutated advanced gastrooesophageal carcinoma (aGEC). Correlative mechanistic studies on tissue and blood samples, could help understanding the evolutionary dynamics of tumors in response to therapy thus optimizing the treatment approach and adding new insight into the antitumor mechanism of the combination approach.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-10-01; most recent amendment 2026-04-09.
Status change: Not Yet Recruiting → Recruiting 2026-04-09
Trial Details
NCT Number NCT07213557
Lead Sponsor National Cancer Institute, Naples
Conditions Advanced or Metastatic Gastrooesophageal Carcinoma
Enrollment 84 participants
Start Date 2026-03-13
Primary Completion 2027-09 (estimated)
Study Completion 2028-05 (estimated)
Updated on ClinicalTrials.gov 2026-04-14