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

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.

Conditions

• Clinical Stage IV Gastric Cancer AJCC v8
• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma
• Metastatic Gastric Carcinoma
• Metastatic Malignant Neoplasm in the Peritoneum

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

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Travis E. Grotz, MD · Mayo Clinic in Rochester

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-29

Primary Completion

2027-04-15

Completion

2030-04-15

FDA Drug

Yes

Countries

• United States

Study Locations