Actively Recruiting
COordinated Nivolumab and IntraperiToneal IL-2 for Gastric CanceR With PeritOneaL Metastasis (CONTROL) Phase 1b Pilot Study
Led by Mayo Clinic · Updated on 2025-12-19
15
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of aldesleukin combined with nivolumab and standard chemotherapy for patients with gastric cancer that has spread to the lining of the abdomen, called peritoneal metastasis. This phase Ib trial aims to assess whether this combination can reduce tumor spread and improve outcomes. Aldesleukin is a protein that stimulates the immune system, while nivolumab is an immunotherapy drug that may help attack cancer cells. The chemotherapy drugs work to stop tumor growth or spread in different ways. Participants receive aldesleukin administered directly into the abdomen on days 1 and 8 of each treatment cycle. They also receive nivolumab and chemotherapy drugs leucovorin calcium, oxaliplatin, and fluorouracil intravenously on specified days within each 14-day cycle. Up to eight cycles are given unless disease progresses or side effects occur. Throughout the trial, patients undergo diagnostic laparoscopy with biopsy, PET/CT or PET/MRI scans, and blood and tissue sample collection. During the study, participants are monitored with scans and lab tests to evaluate tumor response and immune cell changes. Researchers measure the reduction in the peritoneal carcinomatosis index about 90 days after treatment, along with adverse events, progression-free survival, overall survival, and histological tumor response. Follow-ups occur at 30 and 90 days post-treatment, then every three months for up to three years to track long-term safety and effectiveness.
CONDITIONS
Brief Title
Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological confirmation of adenocarcinoma of the stomach or gastroesophageal junction
- Receiving or planning to start first-line therapy with FOLFOX (leucovorin calcium, fluorouracil, oxaliplatin) and nivolumab without disease progression
- No evidence of non-peritoneal metastasis
- ECOG performance status of 0, 1, or 2
- Willingness to provide blood and tissue specimens for research
- Willing to return for follow-up during active monitoring
- Peritoneal Carcinomatosis Index (PCI) between 1 and 24 within 30 days prior to registration
- Clinical, pathological, or radiographic evidence of peritoneal metastasis
- Hemoglobin level at least 8.0 g/dL within 30 days prior to registration
- Absolute neutrophil count of 1000/mm3 or higher within 30 days prior to registration
- Platelet count of 75,000/mm3 or higher within 30 days prior to registration
- Total bilirubin less than or equal to 1.5 times the upper limit of normal within 30 days prior to registration
- ALT and AST levels less than or equal to 1.5 times the upper limit of normal within 30 days prior to registration
- Coagulation tests within normal limits or within therapeutic ranges if on anticoagulants within 30 days prior to registration
- Calculated creatinine clearance of 40 ml/min or higher within 30 days prior to registration
- Negative pregnancy test within 8 days prior to registration for persons who can become pregnant
- Provide written informed consent
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child unwilling to use adequate contraception
- Prior therapies including IL-2, chronic corticosteroids, or immunosuppressive agents (inhaled corticosteroids allowed)
- Severe systemic illnesses or other serious diseases that interfere with safety assessment
- Immunocompromised patients or HIV positive patients on antiretroviral therapy
- Uncontrolled illnesses such as active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, autoimmune disease, or psychiatric/social conditions limiting compliance
- Receiving other investigational agents for the primary cancer
- Active second malignancy receiving systemic treatment within 6 months
- History of myocardial infarction within 6 months or life-threatening ventricular arrhythmias requiring ongoing therapy
- Identification of non-peritoneal metastasis during laparoscopy
- Small bowel obstruction within 15 days prior to registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 16 weeks (8 cycles of 14 days each)
Participants receive aldesleukin intraperitoneally on days 1 and 8 of each cycle, along with nivolumab, leucovorin calcium, oxaliplatin, and continuous fluorouracil intravenously for each 14-day cycle. This treatment may continue for up to 8 cycles if there is no disease progression or unacceptable toxicity. Participants also undergo diagnostic laparoscopy with biopsy, PET/CT or PET/MRI scans, and blood and tissue sample collection throughout this period.
2 visits per cycle for up to 8 cycles, including administration and assessments
Duration - Up to 3 years
After completing treatment, participants are monitored with follow-up visits to assess safety, disease status, and survival outcomes.
Follow-up visits at 30 days, 90 days, then every 3 months for up to 3 years
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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