Actively Recruiting
Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis
Led by Mayo Clinic · Updated on 2025-12-19
15
Participants Needed
1
Research Sites
332 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib trial test effects of aldesleukin in combination with nivolumab and standard chemotherapy in treating patients with gastric cancer that has spread to the tissue lining of the abdomen (peritoneal metastasis). Aldesleukin is similar to a protein that naturally exists in the body that stimulates the immune system to fight infections. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as leucovorin calcium, fluorouracil, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving aldesleukin in combination with nivolumab and standard chemotherapy may work better in treating patients with gastric cancer with peritoneal metastasis.
CONDITIONS
Official Title
Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological confirmation of adenocarcinoma of the stomach or gastroesophageal junction
- Currently receiving or planning to start first-line therapy with leucovorin calcium, fluorouracil, oxaliplatin (FOLFOX), and nivolumab without disease progression
- No radiographic or histological evidence of non-peritoneal metastasis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Willingness to provide mandatory blood and tissue specimens for correlative research
- Willing to return to the enrolling institution for follow-up during the active monitoring phase
- Peritoneal Carcinomatosis Index (PCI) between 1 and 24 obtained within 30 days prior to registration
- Clinical, pathological, or radiographic evidence of peritoneal metastasis per PCI and Peritoneal Regression Grading Score (PRGS)
- Hemoglobin 8.0 g/dL or higher within 30 days prior to registration
- Absolute neutrophil count (ANC) 1000/mm3 or higher within 30 days prior to registration
- Platelet count 75,000/mm3 or higher within 30 days prior to registration
- Total bilirubin 1.5 times upper limit of normal (ULN) or less within 30 days prior to registration
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) 1.5 times ULN or less within 30 days prior to registration
- Prothrombin time (PT)/INR/aPTT 1.5 times ULN or less or within target range if on anticoagulants within 30 days prior to registration
- Calculated creatinine clearance 40 ml/min or higher within 30 days prior to registration
- Negative pregnancy test within 8 days prior to registration for persons of childbearing potential
- Provide written informed consent
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child who are unwilling to use adequate contraception
- Prior therapies including IL-2, chronic corticosteroids, or immunosuppressive agents (inhaled corticosteroids allowed)
- Co-morbid systemic illnesses or severe concurrent diseases that interfere with safety assessment
- Immunocompromised patients or HIV positive patients receiving antiretroviral therapy
- Uncontrolled illnesses such as active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, autoimmune disease, or psychiatric/social conditions limiting compliance
- Receiving any other investigational agent as treatment for the primary cancer
- Active second malignancy receiving systemic treatment within 6 months prior to pre-registration
- History of myocardial infarction within 6 months or congestive heart failure requiring ongoing maintenance therapy for life-threatening arrhythmias
- Identification of non-peritoneal metastasis during laparoscopy
- Prior immune checkpoint inhibitors
- Small bowel obstruction within 15 days prior to registration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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