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Randomized phase 2 study of Simvastatin in patients with ARID1A mutated advanced gastrooesophageal carcinoma treated with Nivolumab and Oxaliplatin-based chemotherapy as first-line treatment (The ARES trial).
EU CTIS ID: 2024-519591-39-00
What this study is testing
To evaluate the efficacy of SIM in patients with HER2 negative and ARID1a mutated aGEC candidate to standard first-line treatment with nivolumab plus oxaliplatin-based chemotherapy (administered until progressive disease, unacceptable toxicity, physician’s decision, pregnancy or patient choice to discontinue), measured as progression-free survival rate at 1-year
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent to study procedures and to correlative studies
- Imaging-documented measurable disease, according to RECIST 1.1 criteria.
- Estimated life expectancy of more than 12 weeks.
- Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL.
- Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN
- Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula)
You likely can't join if
- 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.
- Participation in any interventional drug or medical device study within 30 days prior to treatment start.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment
- Hypesensitivity to simvastatin
- Acute hepatitis or chronic hepatitis
- Personal or familial anamnesis of severe hepatopathy
See the full eligibility criteria
- Written informed consent to study procedures and to correlative studies
- Imaging-documented measurable disease, according to RECIST 1.1 criteria.
- Estimated life expectancy of more than 12 weeks.
- Adequate bone marrow hematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L and platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL.
- Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 (in case of biliary stent) and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 5 X ULN
- Adequate renal function: serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min in males and ≥50 mL/min in females (calculated according to Cockroft-Gault formula)
- Known dihydropyrimidine dehydrogenase (DPYD) activity is mandatory.
- Aged ≥ 18
- Histologically proven of gastrooesophageal carcinoma
- Diagnosis of advanced not operable or metastatic disease
- HER2 negative and ARID1A mutated status at initial diagnosis.
- Available tumor tissue sample
- No prior treatments (chemotherapy, radiation or surgery) for aGEC. Surgery for primary GEC tumor before starting treatment is allowed.
- Patient candidate to standard treatment with nivolumab and oxaliplatin-based chemotherapy as clinical practice (combined positive score ≥ 5).
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at study entry.
- 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.
- Participation in any interventional drug or medical device study within 30 days prior to treatment start.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment
- Hypesensitivity to simvastatin
- Acute hepatitis or chronic hepatitis
- Personal or familial anamnesis of severe hepatopathy
- Known coagulation disorders
- Prior chemotherapy or any other medical treatment for aGEC (previous adjuvant chemotherapy is allowed if terminated > 12 months previously).
- Any contraindication to Nivolumab or oxaliplatin-based chemotherapy.
- Patients who have treatment with statins or fibrates or any medication for hypercholesterolemia
- Major surgical intervention within 4 weeks prior to enrollment.
- Pregnancy and breast-feeding
- Any brain metastasis
- Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study
- History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.