drugset / Trial / NCT05802056

Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis

NCT05802056

Phase 1 Active not recruiting 15 enrolled Mayo Clinic
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2023-11-29
Primary completion
2027-04-24
Completion
2029-06-24

Drugs

EvaluationDrugModalityDoseRoute
Subject aldesleukin Protein / enzyme biologic Other
Background Leucovorin Small molecule Intravenous
Background Nivolumab Monoclonal antibody Intravenous
Background Oxaliplatin Small molecule Intravenous
Background fluorouracil Small molecule Intravenous