Overview

Aldesleukin in Combination With Nivolumab and Standard Chemotherapy for the Treatment of Gastric Cancer With Peritoneal Metastasis, CONTROL Study

Status:
Not yet recruiting
Trial end date:
2026-01-05
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Treatments:
Aldesleukin
Calcium
Calcium, Dietary
Fluorouracil
Folic Acid
Interleukin-2
Leucovorin
Levoleucovorin
Nivolumab
Oxaliplatin
Criteria
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 =< 15 days prior to registration)

- REGISTRATION: Absolute neutrophil count (ANC) >= 1000/mm^3 (obtained =< 15 days prior
to registration)

- REGISTRATION: Platelet count >= 75,000/mm^3 (obtained =< 15 days prior to
registration)

- REGISTRATION: Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 15
days prior to registration)

- REGISTRATION: Alanine aminotransferase (ALT) AND aspartate transaminase (AST) =< 1.5 x
ULN (obtained =< 15 days prior to registration)

- REGISTRATION: Prothrombin time (PT)/international normalized ratio (INR)/activated
partial thromboplastin time (aPTT) =< 1.5 x ULN OR if patient is receiving
anticoagulant therapy, then INR or aPTT is within target range of therapy (obtained =<
15 days prior to registration)

- REGISTRATION: Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault
formula (obtained =< 15 days prior to registration)

- REGISTRATION: Negative pregnancy test done =< 7 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: Active malignancy currently receiving systemic treatment =< 6 months
prior to registration

- 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