Kurzfassung

This is a phase 3, randomized, double-blind, placebo controlled study of adjuvant nivolumab in subjects with resected esophageal cancer (EC), or gastroesophageal junction (GEJ) cancer who have received chemoradiotherapy (CRT) followed by surgery.
After CRT followed by surgery, subjects will sign the informed consent form. Subjects whose tumors do not achieve pathological complete response (non-pCR) will be randomized in a blinded fashion 2:1 ratio to two arms between nivolumab (BMS-936558) or...This is a phase 3, randomized, double-blind, placebo controlled study of adjuvant nivolumab in subjects with resected esophageal cancer (EC), or gastroesophageal junction (GEJ) cancer who have received chemoradiotherapy (CRT) followed by surgery.
After CRT followed by surgery, subjects will sign the informed consent form. Subjects whose tumors do not achieve pathological complete response (non-pCR) will be randomized in a blinded fashion 2:1 ratio to two arms between nivolumab (BMS-936558) or placebo monotherapy. Subjects randomized to nivolumab will receive 240 mg nivolumab administered as an IV infusion over 30 minutes every 2 weeks for 16 weeks (8 doses) followed by 480 mg nivolumab administered as an IV infusion over 30 minutes every 4 weeks beginning at Week 17 (2 weeks after the 8th dose). Subjects randomized to placebo will receive placebo administered as an IV infusion over 30 minutes every 2 weeks for 16 weeks (8 doses) followed by placebo as an IV infusion over 30 minutes every 4 weeks beginning at Week 17 (2 weeks after the 8th dose).
The treatment will be given until disease recurrence, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1-year total duration of study medication.
Stratification factors:
PD-L1 status (≥1% vs.< 1% or indeterminate)
Pathologic lymph node status (positive ≥ypN1 vs. negative ypN0)Histology (squamous vs. adenocarcinoma)This is a phase 3, randomized, double-blind, placebo controlled study of adjuvant nivolumab in subjects with resected esophageal cancer (EC), or gastroesophageal junction (GEJ) cancer who have received chemoradiotherapy (CRT) followed by surgery.
After CRT followed by surgery, subjects will sign the informed consent form. Subjects whose tumors do not achieve pathological complete response (non-pCR) will be randomized in a blinded fashion 2:1 ratio to two arms between nivolumab (BMS-936558) or placebo monotherapy. Subjects randomized to nivolumab will receive 240 mg nivolumab administered as an IV infusion over 30 minutes every 2 weeks for 16 weeks (8 doses) followed by 480 mg nivolumab administered as an IV infusion over 30 minutes every 4 weeks beginning at Week 17 (2 weeks after the 8th dose). Subjects randomized to placebo will receive placebo administered as an IV infusion over 30 minutes every 2 weeks for 16 weeks (8 doses) followed by placebo as an IV infusion over 30 minutes every 4 weeks beginning at Week 17 (2 weeks after the 8th dose).
The treatment will be given until disease recurrence, unacceptable toxicity, or subject withdrawal of consent with a maximum of 1-year total duration of study medication.
Stratification factors:
PD-L1 status (≥1% vs.< 1% or indeterminate)
Pathologic lymph node status (positive ≥ypN1 vs. negative ypN0)Histology (squamous vs. adenocarcinoma)» weiterlesen» einklappen