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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT05802056
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aldesleukin — BIOLOGICAL
    Given IP
  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood and tissue samples
  • Computed Tomography — PROCEDURE
    Undergo PET/CT
  • Diagnostic Laparoscopy — PROCEDURE
    Undergo diagnostic laparoscopy
  • Fluorouracil — DRUG
    Given IV
  • Leucovorin Calcium — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo PET/MRI
  • Nivolumab — BIOLOGICAL
    Given IV
  • Oxaliplatin — DRUG
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT or PET/MRI

Study Details

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.

Key Dates

Start date
Nov 29, 2023
Status verified
Dec 2025
Primary completion
Apr 15, 2027
Completion
Apr 15, 2030

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (aldesleukin, nivolumab, chemotherapy)
    Patients receive aldesleukin IP over at least 40 minutes on days 1 and 8 of each cycle. Patients also receive standard of care nivolumab 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, PET/CT or PET/MRI, and collection of blood and tissue samples throughout the trial.

Primary Outcome Measure

Change of reduction in the peritoneal carcinomatosis index [ Time Frame: About 90 days after last dose of aldesleukin (IL-2) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Travis E. Grotz, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic in Rochester· Rochester, MN

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