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

NCT05802056 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: MC220404NCI-2023-0225022-009956
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change of reduction in the peritoneal carcinomatosis index

  About 90 days after last dose of aldesleukin (IL-2)

• Incidence of adverse events

  About 90 days after last dose of aldesleukin (IL-2)

Secondary Outcomes (3)

• Histological response of the peritoneal metastasis

  About 90 days after last dose of aldesleukin (IL-2)

• Progression free survival

  From study entry to the first of either disease progression or death, assessed up to 3 years

• Overall survival

  From date of study entry to date of death or last follow up, assessed up to 3 years

Study Arms (1)

Treatment (aldesleukin, nivolumab, chemotherapy)

EXPERIMENTAL

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.

Biological: Aldesleukin; Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Diagnostic Laparoscopy; Drug: Fluorouracil; Drug: Leucovorin Calcium; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Drug: Oxaliplatin; Procedure: Positron Emission Tomography

Interventions

Aldesleukin BIOLOGICAL

Given IP

Also known as: 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2, Recombinant Human Interleukin-2

Treatment (aldesleukin, nivolumab, chemotherapy)

Biopsy PROCEDURE

Undergo biopsy

Also known as: BIOPSY_TYPE, Bx

Treatment (aldesleukin, nivolumab, chemotherapy)

Biospecimen Collection PROCEDURE

Undergo collection of blood and tissue samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (aldesleukin, nivolumab, chemotherapy)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography, Computerized axial tomography (procedure), Computerized Tomography (CT) scan

Treatment (aldesleukin, nivolumab, chemotherapy)

Diagnostic Laparoscopy PROCEDURE

Undergo diagnostic laparoscopy

Treatment (aldesleukin, nivolumab, chemotherapy)

Fluorouracil DRUG

Given IV

Also known as: 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione, 5-Fluorouracil, 5-Fluracil, 5-Fu, 5FU, AccuSite, Carac, Fluoro Uracil, Fluouracil, Flurablastin, Fluracedyl, Fluracil, Fluril, Fluroblastin, Ribofluor, Ro 2-9757, Ro-2-9757

Treatment (aldesleukin, nivolumab, chemotherapy)

Leucovorin Calcium DRUG

Given IV

Also known as: Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate, Calcium Leucovorin, Calfolex, Calinat, Cehafolin, Citofolin, Citrec, Citrovorum Factor, Cromatonbic Folinico, Dalisol, Disintox, Divical, Ecofol, Emovis, Factor, Citrovorum, Flynoken A, Folaren, Folaxin, FOLI-cell, Foliben, Folidan, Folidar, Folinac, Folinate Calcium, folinic acid, Folinic Acid Calcium Salt Pentahydrate, Folinoral, Folinvit, Foliplus, Folix, Imo, Lederfolat, Lederfolin, Leucosar, leucovorin, Rescufolin, Rescuvolin, Tonofolin, Wellcovorin

Treatment (aldesleukin, nivolumab, chemotherapy)

Magnetic Resonance Imaging PROCEDURE

Undergo PET/MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), MRIs, sMRI, Structural MRI

Treatment (aldesleukin, nivolumab, chemotherapy)

Nivolumab BIOLOGICAL

Given IV

Also known as: BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo, ABP 206, BCD-263, Nivolumab Biosimilar ABP 206, Nivolumab Biosimilar BCD-263

Treatment (aldesleukin, nivolumab, chemotherapy)

Oxaliplatin DRUG

Given IV

Also known as: 1-OHP, Ai Heng, Aiheng, Dacotin, Dacplat, Diaminocyclohexane Oxalatoplatinum, Eloxatin, Eloxatine, JM-83, Oxalatoplatin, Oxalatoplatinum, RP 54780, RP-54780, SR-96669

Treatment (aldesleukin, nivolumab, chemotherapy)

Positron Emission Tomography PROCEDURE

Undergo PET/CT or PET/MRI

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT, Positron emission tomography (procedure)

Treatment (aldesleukin, nivolumab, chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PRE-REGISTRATION: Age \>= 18 years
• PRE-REGISTRATION: Disease characteristics
• Histological confirmation of adenocarcinoma of the stomach or gastroesophageal junction (GEJ)
• Currently receiving first-line therapy with leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) and nivolumab without evidence of disease progression OR planning to start first-line therapy with FOLFOX and nivolumab
• PRE-REGISTRATION: No radiographic or histological evidence of non-peritoneal metastasis
• PRE-REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
• PRE-REGISTRATION: Willingness to provide mandatory blood specimens for correlative research
• PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
• PRE-REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
• REGISTRATION: Peritoneal Carcinomatosis Index (PCI) \>= 1 and =\< 24 obtained =\< 30 days prior to registration
• REGISTRATION: Clinical, pathological, or radiographic evidence of peritoneal metastasis per PCI and Peritoneal Regression Grading Score (PRGS)
• REGISTRATION: Hemoglobin \>= 8.0 g/dL (obtained =\< 30 days prior to registration)
• REGISTRATION: Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 30 days prior to registration)
• REGISTRATION: Platelet count \>= 75,000/mm\^3 (obtained =\< 30 days prior to registration)
• REGISTRATION: Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 30 days prior to registration)

You may not qualify if:

• PRE-REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
• PRE-REGISTRATION: Any of the following prior therapies: IL-2 or chronic corticosteroids, or immunosuppressive agents
• NOTE: Inhaled corticosteroids are allowed
• PRE-REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• PRE-REGISTRATION: Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
• PRE-REGISTRATION: Uncontrolled intercurrent illness including, but not limited to:
• Ongoing or active infection
• Symptomatic congestive heart failure
• Unstable angina pectoris
• Cardiac arrhythmia
• Or psychiatric illness/social situations that would limit compliance with study requirements
• Autoimmune disease

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

aldesleukin; Biopsy; Specimen Handling; Laparoscopy; Fluorouracil; dehydroftorafur; Leucovorin; Magnetic Resonance Spectroscopy; Nivolumab; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Endoscopy; Minimally Invasive Surgical Procedures; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Spectrum Analysis; Chemistry Techniques, Analytical; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• Travis E. Grotz, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2030
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

US (1)