NCT05802056

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the reduction in the peritoneal carcinomatosis index (PCI) after completion of the study treatment. SECONDARY OBJECTIVES: I. Evaluate histological response of the peritoneal metastasis to study treatment using the peritoneal regression grading score (PRGS). II. Assess overall survival (OS). III. Assess progression-free survival (PFS). IV. Assess safety and tolerability of the study regimen. TERTIARY AND CORRELATIVE RESEARCH OBJECTIVES: I. Assess the number and percentage of patients that successfully undergo complete cytoreductive surgery after treatment. II. Evaluate for helper T cell, cytotoxic T cell, natural killer (NK) cells as well as T-reg cells in blood and peritoneal fluid. III. Evaluate the neutrophilic, lymphocytic, and eosinophilic infiltration of tumor using a standardized classification. OUTLINE: Patients receive aldesleukin intraperitoneally (IP) over at least 40 minutes on days 1 and 8 of each cycle. Patients also receive standard of care nivolumab intravenously (IV) over 30 minutes on day 1, leucovorin calcium IV over 2 hours on day 1, oxaliplatin IV over 2 hours on day 1, and flurouracil IV continuously over 46 hours on days 1-3 for each cycle. Cycles repeat every 14 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo diagnostic laparoscopy with biopsy, positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI), and collection of blood and tissue samples throughout the trial. After completion of study treatment, patients follow up at 30 days, 90 days then every 3 months for up to 3 years.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-29
• Primary completion: 2027-04-15
• Completion: 2030-04-15
• First posted: 2023-04-06
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study