COordinated Nivolumab and IntraperiToneal IL-2 for Gastric CanceR With PeritOneaL Metastasis (CONTROL) Phase 1b Pilot Study
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the reduction in the peritoneal carcinomatosis index (PCI) after completion of the study treatment. SECONDARY OBJECTIVES: I. Evaluate histological response of the peritoneal metastasis to study treatment using the peritoneal regression grading score (PRGS). II. Assess overall survival (OS). III. Assess progression-free survival (PFS). IV. Assess safety and tolerability of the study regimen. TERTIARY AND CORRELATIVE RESEARCH OBJECTIVES: I. Assess the number and percentage of patients that successfully undergo complete cytoreductive surgery after treatment…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 (…
Interventions
- BiologicalAldesleukin
Given IP
- ProcedureBiopsy
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo collection of blood and tissue samples
- ProcedureComputed Tomography
Undergo PET/CT
- ProcedureDiagnostic Laparoscopy
Undergo diagnostic laparoscopy
- DrugFluorouracil
Given IV
- DrugLeucovorin Calcium
Given IV
Location
- Mayo Clinic in RochesterRochester, Minnesota