OncoMatch/Clinical Trials/NCT05802056
Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis
Is NCT05802056 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for clinical stage iv gastric cancer ajcc v8.
Treatment: Aldesleukin · Fluorouracil · Leucovorin Calcium · Nivolumab · Oxaliplatin — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastric Cancer
Esophageal Carcinoma
Tumor Agnostic
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: platinum-based chemotherapy (leucovorin calcium, fluorouracil, oxaliplatin) — first-line
Currently receiving first-line therapy with leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) and nivolumab without evidence of disease progression OR planning to start first-line therapy with FOLFOX and nivolumab
Must have received: anti-PD-1 therapy (nivolumab) — first-line
Currently receiving first-line therapy with leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) and nivolumab without evidence of disease progression OR planning to start first-line therapy with FOLFOX and nivolumab
Cannot have received: IL-2
Any of the following prior therapies: IL-2 or chronic corticosteroids, or immunosuppressive agents
Cannot have received: chronic corticosteroids
Exception: inhaled corticosteroids allowed
Any of the following prior therapies: IL-2 or chronic corticosteroids, or immunosuppressive agents
Cannot have received: immunosuppressive agents
Exception: inhaled corticosteroids allowed
Any of the following prior therapies: IL-2 or chronic corticosteroids, or immunosuppressive agents
Cannot have received: immune checkpoint inhibitor
Any of the following therapies: prior immune checkpoint inhibitors, prior IL-2, or chronic corticosteroids or immunosuppressive agents
Lab requirements
Blood counts
Hemoglobin >= 8.0 g/dL; ANC >= 1000/mm^3; Platelet count >= 75,000/mm^3
Kidney function
Calculated creatinine clearance >= 40 ml/min using Cockcroft-Gault formula
Liver function
Total bilirubin <= 1.5 x ULN; ALT and AST <= 1.5 x ULN
Hemoglobin >= 8.0 g/dL; ANC >= 1000/mm^3; Platelet count >= 75,000/mm^3; Total bilirubin <= 1.5 x ULN; ALT and AST <= 1.5 x ULN; Calculated creatinine clearance >= 40 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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