Immune Checkpoint Therapy With Nivolumab Esophageal Squamous Cell Carcinoma
Status:
Active, not recruiting
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
In this multi-institution phase I/II trial, the investigators have chosen paclitaxel and
carboplatin using a schedule and doses identical to those used in the CROSS trial. Following
a run-in with nivolumab alone at 240 mg IVPB every 2 weeks for 2 doses, nivolumab at 240 mg
every 2 weeks will be added to paclitaxel and carboplatin, which will be dosed according to
the standard of care established by the CROSS trial: paclitaxel 50 mg/m2 weekly for 6 weeks
and carboplatin AUC 2 weekly for 6 weeks. Concurrent radiation will be administered with
chemotherapy at 1.8 Gy/fraction × 28 fractions to a total dose of 50.4 Gy, the standard
radiation dose administered in the United States for trimodality therapy that includes
concurrent therapy with carboplatin and paclitaxel. A decrease in dose to 41.4 Gy per the
protocol established by van Hagen, et al. will be permitted before discontinuing therapy due
to unacceptable toxicity. While the CROSS study administered only 5 weekly doses of
chemotherapy during the 5 weeks of radiation, the higher dose of 50.4 Gy (1.8 Gy/fraction ×28
fractions over 5½ weeks) utilized in this study permits for a sixth dose during the
additional week of radiation.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health