Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer (NCT03776487) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Nivolumab, Ipilimumab and Chemoradiation in Treating Patients With Resectable Gastric Cancer
United States32 participantsStarted 2019-01-07
Plain-language summary
This pilot phase I/II trial studies the side effects and how well nivolumab and ipilimumab in combination with chemotherapy and radiation therapy work in treating patients with gastric cancer that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, 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. Intensity-modulated radiation therapy uses thin beams of radiation of different strengths aimed at the tumor from many angles. This type of radiation therapy may reduce the damage to healthy tissue near the tumor. Giving nivolumab, ipilimumab, chemotherapy and radiation therapy may work better in treating patients with gastric cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.
* All subjects must have localized/eligible for surgery gastric cancer (GC) or GEJ carcinoma type III, with negative peritoneal washing. Subjects must have histologically confirmed predominant adenocarcinoma. The documentation of GEJ involvement can include biopsy, endoscopy, or imaging.
* Subject must be previously untreated with systemic treatment (including HER 2 inhibitors) given as primary therapy for advanced or metastatic disease. No prior neoadjuvant chemotherapy, immunotherapy, radiotherapy and/or chemoradiotherapy are permitted.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Absolute neutrophil count (ANC) \>= 1,500/mcL (within 28 days of treatment initiation).
* Platelets \>=100,000/mcL (within 28 days of treatment initiation).
* Hemoglobin \>= 9 g/dL or \> 5.6 mmol/L; if patient is not actively bleeding and has hemoglobin of \< 9g/dL, patient can receive blood transfusion to increase hemoglobin to \>= 9g/dL (within 28 days of treatment initiation)…