Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Periton… (NCT05802056) | Clinical Trial Compass
RecruitingPhase 1
Aldesleukin With Nivolumab and Standard Chemotherapy for Treatment of Gastric Cancer With Peritoneal Metastasis
United States15 participantsStarted 2023-11-29
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 bil…
What they're measuring
1
Change of reduction in the peritoneal carcinomatosis index
Timeframe: About 90 days after last dose of aldesleukin (IL-2)
2
Incidence of adverse events
Timeframe: About 90 days after last dose of aldesleukin (IL-2)