At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Trial of Avelumab in Combination With Chemoradiation in the Treatment of Stage II/III Resectable Esophageal and Gastroesophageal Cancer
In Brief
A Phase 2 clinical trial evaluating Avelumab combined with Chemoradiation, Carboplatin, and 2 other interventions for Resectable Esophageal Cancer and GastroEsophageal Cancer. Completed, enrolled 22 participants across 1 site.
Detailed Summary
This is a 2 part Phase I/II clinical trial evaluating the safety, tolerability and efficacy of avelumab in combination with chemoradiation in patients with resectable esophageal and gastroesophageal cancer. Part 1: This is the run-in phase of the trial. This portion will determine the safety and tolerability of avelumab in combination with chemoradiotherapy in 6 patients. The proposed combination will be considered as safe if dose limiting toxicities are observed in at most 1 patient. Part 2: This is a Phase 2 portion of the trial, which will evaluate the efficacy of the proposed treatment regimen in patients with stage II/III resectable esophageal and gastroesophageal cancer
Study Details
Timeline
Interventions
Co-administration of avelumab with chemoradiation in pre-operative period.
Weekly Carboplatin (AUC2) \[intravenous infusion on days 1, 8, 15, 22, \& 29\]
Weekly paclitaxel \[intravenous infusion on days 1, 8, 15, 22, \& 29\]
Radiation therapy \[23 fractions, M-F, estimated completion day 35\]