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Simvastatin Efficacy in ARID1A Mutated Advanced gastroESophageal Carcinoma Treated With Immunotherapy

NCT07213557 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-04-14

No results posted yet for this study

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.

Conditions

  • Advanced or Metastatic Gastrooesophageal Carcinoma

Interventions

DRUG

simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy

Nivolumab will be administered as 30 minutes intravenous infusion at the dosage of 360 mg every 3 weeks or 240 mg every 2 weeks as flat dose followed by investigator's choice of oxaliplatin-based chemotherapy regimen: * XELOX (oxaliplatin 130 mg/m2 on day 1 and capecitabine 1,000 mg/m2 orally twice daily on days 1- 14 administered every 3 weeks) or * mFOLFOX6 (oxaliplatin 85 mg/m2 on day 1 followed by lederfolin 200 mg m2 on day 1, fluorouracil 400 mg m2 on day 1 and 2,400 mg m2 continuous infusion over 46 hours every 2 weeks) * SIM will be administered per os daily at a fixed dosage of 40 mg that represents the recommended dose as cholesterol lowering agents.

DRUG

standard nivolumab and oxaliplatin- based chemotherapy

Nivolumab will be administered as 30 minutes intravenous infusion at the dosage of 360 mg every 3 weeks or 240 mg every 2 weeks as flat dose followed by investigator's choice of oxaliplatin-based chemotherapy regimen: * XELOX (oxaliplatin 130 mg/m2 on day 1 and capecitabine 1,000 mg/m2 orally twice daily on days 1- 14 administered every 3 weeks) or * mFOLFOX6 (oxaliplatin 85 mg/m2 on day 1 followed by lederfolin 200 mg m2 on day 1, fluorouracil 400 mg m2 on day 1 and 2,400 mg m2 continuous infusion over 46 hours every 2 weeks)

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-13
Primary Completion
2027-09-30
Completion
2028-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07213557 on ClinicalTrials.gov