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RECRUITING
NCT05802056
PHASE1

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

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: COordinated Nivolumab and IntraperiToneal IL-2 for Gastric CanceR With PeritOneaL Metastasis (CONTROL) Phase 1b Pilot Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2023-11-29

Completion Date

2030-04-15

Last Updated

2025-12-19

Healthy Volunteers

No

Interventions

BIOLOGICAL

Aldesleukin

Given IP

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood and tissue samples

PROCEDURE

Computed Tomography

Undergo PET/CT

PROCEDURE

Diagnostic Laparoscopy

Undergo diagnostic laparoscopy

DRUG

Fluorouracil

Given IV

DRUG

Leucovorin Calcium

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo PET/MRI

BIOLOGICAL

Nivolumab

Given IV

DRUG

Oxaliplatin

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT or PET/MRI

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States