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Phase II Study of Short Course FOLFOX Chemotherapy with Either Nivolumab or Nivolumab + Radiation in the First Line Treatment of Metastatic or Unresectable Gastroesophageal Cancers (BMS Protocol CA209-76L)
This is a randomized phase II study examining nivolumab alone versus radiation therapy with nivolumab in subjects who did not have disease progression to initial therapy with the combination of FOLFOX and Nivolumab.
To examine the efficacy of the addition of fractionated radiation to nivolumab compared with nivolumab alone in subjects with advanced esophagogastric adenocarcinoma, as assessed by the 12-month progression free survival (PFS) rate. To examine the efficacy of short course chemotherapy (3 months) and nivolumab, as assessed by the 12-month PFS rate. (2) To examine other measures of efficacy of the combination of FOLFOX with Nivolumab with or without radiation in advanced esophagogastric adenocarcinoma including the disease control rate, overall survival and progression free survival. (3) To demonstrate the safety of each treatment arm as assessed by the attributable grade 3 or 4 toxicity as assessed by CTCAE v 5.0.
BMS-936558 (Nivolumab); FOLFOX (); Nivolumab (Opdivo)