New drug cocktail aims to fight stomach cancer in the abdomen
NCT ID NCT05802056
First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 5 times
Summary
This early-phase trial tests whether adding an immune-boosting drug (aldesleukin) to standard chemotherapy and another immunotherapy (nivolumab) can help control stomach cancer that has spread to the lining of the abdomen. About 15 adults with this advanced cancer will receive the combination. The main goals are to check safety and see if the cancer shrinks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab and aldesleukin (a lab-made immune protein)
- What this could lead to
- If this works, it could point toward a new treatment option for stomach cancer that has spread to the abdomen lining.
- What could go wrong
- This is a very early, small phase 1 trial with only 15 people. It is designed mainly to check safety, not yet to prove if the combination works. Side effects from the immune-boosting drugs can be serious.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) * REGISTRATION: Alanine aminotransferase (ALT) AND aspartate transaminase (AST) =\< 1.5 x ULN (obtained =\< 30 days prior to registration) * REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR) =\< 1.5 x ULN OR if patient is receiving anticoagulant therapy, then PT/INR is within target range of therapy (obtained =\< 30 days prior to registration) * REGISTRATION: Calculated creatinine clearance \>= 40 ml/min using the Cockcroft-Gault formula (obtained =\< 30 days prior to registration) * REGISTRATION: Negative pregnancy test done =\< 8 days prior to registration, for persons of childbearing potential only * REGISTRATION: Provide written informed consent * REGISTRATION: Willingness to provide mandatory blood specimens for correlative research * REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research * REGISTRATION: Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) Exclusion Criteria: * 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 * PRE-REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * PRE-REGISTRATION: Active second malignancy currently receiving systemic treatment =\< 6 months prior to pre-registration * PRE-REGISTRATION: History of myocardial infarction =\< 6 months prior to pre-registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * REGISTRATION: Identification of non-peritoneal metastasis during laparoscopy * 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 * REGISTRATION: Any of the following therapies: prior immune checkpoint inhibitors, prior IL-2, or chronic corticosteroids or immunosuppressive agents * NOTE: Inhaled corticosteroids are allowed. One-time antiemetic dose is allowed * 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 * REGISTRATION: Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy * 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 (e.g., substance abuse) that would limit compliance with study requirements * Autoimmune disease requiring systemic treatment * Small bowel obstruction * REGISTRATION: Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm * REGISTRATION: History of myocardial infarction =\< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias * REGISTRATION: Small bowel obstruction \< 15 days prior to registration
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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