Advanced or Metastatic Gastrooesophageal CarcinomaPhase 2NCT07213557
Simvastatin Efficacy in ARID1A Mutated Advanced gastroESophageal Carcinoma Treated With Immunotherapy
A Phase 2 study testing standard nivolumab and oxaliplatin- based chemotherapy and simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy in people with Advanced or Metastatic Gastrooesophageal Carcinoma, run by National Cancer Institute, Naples at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Gastrooesophageal Carcinoma
- What is being tested?
- standard nivolumab and oxaliplatin- based chemotherapy and simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteItaly
- Study dates
- 13 Mar 2026to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- HER2 negative and ARID1A mutated status at initial diagnosis.
- Available tumor tissue sample.
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- 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.
- 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. The same criteria, except for the status of ARID1A, will be followed to select the 28 consecutive HER2-negative and ARID1A non mutated aGEC patients of observational cohort.
Who cannot join
- 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.
- Major surgical intervention within 4 weeks prior to enrollment.
- Pregnancy and breast-feeding.
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- 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.
- 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. The same criteria will be followed to select the 28 consecutive HER2-negative and ARID1A non mutated aGEC patients of observational cohort.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale Tumori Fondazione G. Pascale
Naples, Italia, 80131
Antonio Avallone, M.D., 08117770357, a.avallone@istitutotumori.na.it
About this study
Official title: 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)
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.
Read the detailed description
This study is a multicentric open label academic non comparative randomized phase-2 study.
Before starting study treatment, at the time of enrollment, patients, with aGEC HER2 negative with ARID1A mutation in tumors candidates for immunotherapy (CPS ≥ 5), will be randomized electronically 1:1 to one of the two arms:
- ARM A, standard treatment with nivolumab + oxaliplatin- based chemotherapy (mFOLFOX6 or XELOX regimen)
- ARM B, experimental treatment with simvastatin oral daily at a fixed dosage of 40 mg, in addition to standard treatment with nivolumab + oxaliplatin-based chemotherapy (mFOLFOX6 or XELOX regimen).
Nivolumab will be administered as flat dose of 360 mg every 3 weeks or 240 mg every 2 weeks with 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) Patients will continue to receive study treatment until treatment failure as previous defined, unacceptable toxicity, physician's decision, patient's refusal, or any other discontinuation criteria.
Patients who are progression free after 8 cycles (24 weeks) of XELOX or 12 cycles (24 weeks) of mFOLFOX6 treatment will continue maintenance with fluorouracile (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) or capecitabine (capecitabine 1,250 mg/m2 orally twice daily on days 1-14 administered every 3 weeks), as previously assigned until treatment failure as reported above.
28 aGEC HER2 negative and ARID1A mutated patients will be required along to other 28 aGEC HER2 negative and ARID1A mutated patients as calibration arm, for a total of 56 subjects.
All subjects who finish treatment, whichever the reason, will enter in the follow-up. All patients will be followed until death and data on subsequent treatment will be collected.
An initial safety run-in phase involves a safety evaluation after the first 6 patients are randomly assigned to Arm B. Enrollment will be paused after the first 6 patients randomly assigned to Arm B complete 2 cycles of treatment. The enrollment will be interrupted if the treatment combination will be judged not feasible and major safety concerns will arise. A safety review will be conducted, and recommendations will be made by the Steering Committee. The study will continue if there are 2 or fewer adverse events (AEs) of grade 3 or higher deemed related to the addition of simvastatin to the standard treatment with nivolumab + oxaliplatin-based chemotherapy.
All measurable and non-measurable lesions must be documented at screening (within 28 days prior to randomization) and re-assessed at each subsequent tumor evaluation (every 12 weeks). Tumor assessment by CT scan (chest, abdomen and pelvis) or MRI (abdomen and pelvis); CEA, CA 19.9; and any other tests resulted positive during baseline staging, will be performed every 12 weeks during treatment until treatment failure in both arms. Patients discontinuing study treatment without progressive disease, will undergo tumor assessments every 12 weeks until progressive disease or study withdrawal.
Toxicities will be evaluated at each clinical visit throughout the study treatment and up to 4 weeks after last cycle of treatment accordingly to the Common Terminology Criteria for Adverse Events (AEs) of the National Cancer Institute (CTCAE-NCI) version 5.0.
Quality of Life will be assessed by the EORTC QLQ-C30 v.3.0 questionnaire that will be completed by patients at baseline (prior to treatment, once eligibility is confirmed) and every 12 weeks until disease progression or, treatment failure.
HER2-negative aGEC patients with ARID1A non mutated tumors of observational cohort who are candidates for immunotherapy (ARM C) will be treated with standard treatment with nivolumab and oxaliplatin-based chemotherapy in the same way as the patients in ARM A (28 patients)
- Being tested
- standard nivolumab and oxaliplatin- based chemotherapy, simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy
- Keywords
- HER2 negative, ARID1A mutated, Simvastatin, gastrooesophageal carcinoma, liquid biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard nivolumab and oxaliplatin- based chemotherapyDrug
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)
simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM A - standard | Active comparator | Patients with HER2 negative aGEC eligible for the standard treatment with nivolumab and oxaliplatin- based chemotherapy (CPS ≥ 5) will be evaluated for ARID1A expression by immunohistochemistry on tumor tissue. Patients with ARID1A mutated will be randomized to receive standard nivolumab and oxaliplatin- based chemotherapy (standard arm, ARM A) or simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy (experimental arm, ARM B) Receives: Drug: standard nivolumab and oxaliplatin- based chemotherapy |
| ARM B | Experimental | Patients with HER2 negative aGEC eligible for the standard treatment with nivolumab and oxaliplatin- based chemotherapy (CPS ≥ 5) will be evaluated for ARID1A expression by immunohistochemistry on tumor tissue. Patients with ARID1A mutated will be randomized to receive standard nivolumab and oxaliplatin- based chemotherapy (standard arm, ARM A) or simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy (experimental arm, ARM B) Receives: Drug: simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy |
| ARM C | Other | Observational Cohort: patients with ARID1A not mutated of observational cohort (ARM C) will be treated with standard treatment with nivolumab and oxaliplatin-based chemotherapy and compared with standard ARM A as exploratory comparison to evaluate the predictive value for immunotherapy of ARID1A. Receives: Drug: standard nivolumab and oxaliplatin- based chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival rate at 1-year (PFS 1-year)
Progression Free Survival rate at 1-year (PFS 1-year) PFS 1-year is defined as the rate of assessable patients alive and not progressed after 1 year from initiation of study (i.e randomization) to the first documentation of: objective disease progression by RECIST 1.1 criteria, including deterioration of clinical conditions preventing radiological restaging, treatment interruption due to AEs followed by initiation of an alternative antineoplastic treatment, or death due to any cause, whichever occurs first in one year. It will be measured as the rate of assessable patients alive and without disease progression, as previously defined, at 1 year.
Measured: up to 1 year to randomization
Secondary outcomes (6)
Objective Tumor Response Rate (ORR)
Objective Tumor Response Rate (ORR) defined as the proportion of patients with complete/partial response, assessed according to RECIST criteria 1.1.
Measured: up to 1 year last patients randomized
Disease Control Rate (DCR)
Disease Control Rate (DCR) defined as the proportion of patients with complete/partial response and stable disease as their best response, assessed according to RECIST criteria 1.1.
Measured: up to 1 year to randomization
Progression-free survival (PFS)
Progression-free survival (PFS) measured as the time from the date of randomization until the date of the first observation of disease progression or death due to any cause, whichever occurs first, or the last date of follow up.
Measured: up to 1 year to randomization
Overall survival (OS)
Overall survival (OS) calculated as the time from the date of randomization until the date of death from any cause, or the last date of follow up.
Measured: up to 1 year to randomization
Safety evaluated as adverse events graded according to NCI CTCAE v 5.0.
Safety evaluated as adverse events graded according to NCI CTCAE v 5.0.
Measured: From the start of the first treatment cycle until the end of active treatment
Quality of life (QoL)
Quality of life (QoL) investigated through the EORTC QLQ-C30
Measured: at baseline and every 12 weeks until disease progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start13 Mar 2026
- Primary completionSep 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Gastrooesophageal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213557
- Sponsor's protocol ID
- ARES
- Other IDs
- 2024-519591-39-00
- Status last verified
- Apr 2026
- First submitted
- 22 Sep 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07213557
- Acronym / sponsor ID
- ARES
- Keywords
- HER2 negative, ARID1A mutated, Simvastatin, gastrooesophageal carcinoma, liquid biopsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a multicentric open label academic non comparative randomized phase-2 study.
Before starting study treatment, at the time of enrollment, patients, with aGEC HER2 negative with ARID1A mutation in tumors candidates for immunotherapy (CPS ≥ 5), will be randomized electronically 1:1 to one of the two arms:
- ARM A, standard treatment with nivolumab + oxaliplatin- based chemotherapy (mFOLFOX6 or XELOX regimen)
- ARM B, experimental treatment with simvastatin oral daily at a fixed dosage of 40 mg, in addition to standard treatment with nivolumab + oxaliplatin-based chemotherapy (mFOLFOX6 or XELOX regimen).
Nivolumab will be administered as flat dose of 360 mg every 3 weeks or 240 mg every 2 weeks with 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) Patients will continue to receive study treatment until treatment failure as previous defined, unacceptable toxicity, physician's decision, patient's refusal, or any other discontinuation criteria.
Patients who are progression free after 8 cycles (24 weeks) of XELOX or 12 cycles (24 weeks) of mFOLFOX6 treatment will continue maintenance with fluorouracile (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) or capecitabine (capecitabine 1,250 mg/m2 orally twice daily on days 1-14 administered every 3 weeks), as previously assigned until treatment failure as reported above.
28 aGEC HER2 negative and ARID1A mutated patients will be required along to other 28 aGEC HER2 negative and ARID1A mutated patients as calibration arm, for a total of 56 subjects.
All subjects who finish treatment, whichever the reason, will enter in the follow-up. All patients will be followed until death and data on subsequent treatment will be collected.
An initial safety run-in phase involves a safety evaluation after the first 6 patients are randomly assigned to Arm B. Enrollment will be paused after the first 6 patients randomly assigned to Arm B complete 2 cycles of treatment. The enrollment will be interrupted if the treatment combination will be judged not feasible and major safety concerns will arise. A safety review will be conducted, and recommendations will be made by the Steering Committee. The study will continue if there are 2 or fewer adverse events (AEs) of grade 3 or higher deemed related to the addition of simvastatin to the standard treatment with nivolumab + oxaliplatin-based chemotherapy.
All measurable and non-measurable lesions must be documented at screening (within 28 days prior to randomization) and re-assessed at each subsequent tumor evaluation (every 12 weeks). Tumor assessment by CT scan (chest, abdomen and pelvis) or MRI (abdomen and pelvis); CEA, CA 19.9; and any other tests resulted positive during baseline staging, will be performed every 12 weeks during treatment until treatment failure in both arms. Patients discontinuing study treatment without progressive disease, will undergo tumor assessments every 12 weeks until progressive disease or study withdrawal.
Toxicities will be evaluated at each clinical visit throughout the study treatment and up to 4 weeks after last cycle of treatment accordingly to the Common Terminology Criteria for Adverse Events (AEs) of the National Cancer Institute (CTCAE-NCI) version 5.0.
Quality of Life will be assessed by the EORTC QLQ-C30 v.3.0 questionnaire that will be completed by patients at baseline (prior to treatment, once eligibility is confirmed) and every 12 weeks until disease progression or, treatment failure.
HER2-negative aGEC patients with ARID1A non mutated tumors of observational cohort who are candidates for immunotherapy (ARM C) will be treated with standard treatment with nivolumab and oxaliplatin-based chemotherapy in the same way as the patients in ARM A (28 patients)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM A - standard | Active comparator | Drug: standard nivolumab and oxaliplatin- based chemotherapyPatients with HER2 negative aGEC eligible for the standard treatment with nivolumab and oxaliplatin- based chemotherapy (CPS ≥ 5) will be evaluated for ARID1A expression by immunohistochemistry on tumor tissue. Patients with ARID1A mutated will be randomized to receive standard nivolumab and oxaliplatin- based chemotherapy (standard arm, ARM A) or simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy (experimental arm, ARM B) |
| ARM B | Experimental | Drug: simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapyPatients with HER2 negative aGEC eligible for the standard treatment with nivolumab and oxaliplatin- based chemotherapy (CPS ≥ 5) will be evaluated for ARID1A expression by immunohistochemistry on tumor tissue. Patients with ARID1A mutated will be randomized to receive standard nivolumab and oxaliplatin- based chemotherapy (standard arm, ARM A) or simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy (experimental arm, ARM B) |
| ARM C | Other | Drug: standard nivolumab and oxaliplatin- based chemotherapyObservational Cohort: patients with ARID1A not mutated of observational cohort (ARM C) will be treated with standard treatment with nivolumab and oxaliplatin-based chemotherapy and compared with standard ARM A as exploratory comparison to evaluate the predictive value for immunotherapy of ARID1A. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
- HER2 negative and ARID1A mutated status at initial diagnosis.
Key exclusion criteria (15 listed)
- 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.
- Major surgical intervention within 4 weeks prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard nivolumab and oxaliplatin- based chemotherapyNivolumab 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) | Drug | ARM A - standard, ARM C |
| simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapyNivolumab 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 | ARM B |
Primary outcome
Progression Free Survival rate at 1-year (PFS 1-year)
Time frame: up to 1 year to randomization
Progression Free Survival rate at 1-year (PFS 1-year) PFS 1-year is defined as the rate of assessable patients alive and not progressed after 1 year from initiation of study (i.e randomization) to the first documentation of: objective disease progression by RECIST 1.1 criteria, including deterioration of clinical conditions preventing radiological restaging, treatment interruption due to AEs followed by initiation of an alternative antineoplastic treatment, or death due to any cause, whichever occurs first in one year. It will be measured as the rate of assessable patients alive and without disease progression, as previously defined, at 1 year.
6 secondary outcomes
Objective Tumor Response Rate (ORR)
Time frame: up to 1 year last patients randomized
Disease Control Rate (DCR)
Time frame: up to 1 year to randomization
Progression-free survival (PFS)
Time frame: up to 1 year to randomization
Overall survival (OS)
Time frame: up to 1 year to randomization
Safety evaluated as adverse events graded according to NCI CTCAE v 5.0.
Time frame: From the start of the first treatment cycle until the end of active treatment
Quality of life (QoL)
Time frame: at baseline and every 12 weeks until disease progression.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing standard nivolumab and oxaliplatin- based chemotherapy and simvastatin in combination with standard nivolumab and oxaliplatin-based chemotherapy in people with Advanced or Metastatic Gastrooesophageal Carcinoma, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Avallone, MD (08117770357, a.avallone@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival rate at 1-year (PFS 1-year) (time frame: up to 1 year to randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.