RecruitingPhase 1NCT05802056

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

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


Sponsor

Mayo Clinic

Enrollment

15 participants

Start Date

Nov 29, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a drug called aldesleukin (a type of immune-boosting protein) to the standard immunotherapy and chemotherapy regimen (nivolumab + FOLFOX) can help treat stomach or gastroesophageal junction cancer that has spread to the lining of the abdomen (peritoneal metastasis). **You may be eligible if:** - You are 18 or older - You have confirmed adenocarcinoma (a type of cancer) of the stomach or where the stomach meets the esophagus - Your cancer has spread only to the lining of the abdomen (not to other organs like liver or lungs) - You are currently receiving or about to start FOLFOX chemotherapy plus nivolumab - You are in good enough health to participate (ECOG score 0–2) - You are willing to provide blood and tissue samples for research **You may NOT be eligible if:** - Your cancer has spread to organs other than the peritoneum (lining of the abdomen) - You are not on or not planning to start the required chemotherapy regimen - Your blood counts or organ function are below required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAldesleukin

Given IP

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo collection of blood and tissue samples

PROCEDUREComputed Tomography

Undergo PET/CT

PROCEDUREDiagnostic Laparoscopy

Undergo diagnostic laparoscopy

DRUGFluorouracil

Given IV

DRUGLeucovorin Calcium

Given IV

PROCEDUREMagnetic Resonance Imaging

Undergo PET/MRI

BIOLOGICALNivolumab

Given IV

DRUGOxaliplatin

Given IV

PROCEDUREPositron Emission Tomography

Undergo PET/CT or PET/MRI


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT05802056


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