Simvastatin Efficacy in ARID1A Mutated Advanced gastroESophageal Carcinoma Treated With Immunotherapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples
About this trial
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.
Eligibility criteria
Qualifiers
Written informed consent to study procedures and to correlative studies.
Aged ≥ 18.
Histologically proven of gastrooesophageal carcinoma
Diagnosis of advanced not operable or metastatic disease.
Disqualifiers
Prior malignancy within five years. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
Prior chemotherapy or any other medical treatment for aGEC (previous adjuvant chemotherapy is allowed if terminated > 12 months previously).
Any contraindication to Nivolumab, simvastatin or oxaliplatin-based chemotherapy.
Patients who have treatment with statins or fibrates or any medication for hypercholesterolemia.
Trial design
Treatments tested in this trial
- standard nivolumab and oxaliplatin- based chemotherapy
- simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy
Treatment groups
84 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov