drugset / Trial / NCT03490292
Avelumab With Chemoradiation for Stage II/III Resectable Esophageal and Gastroesophageal Cancer
Non-randomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2018-05-29
- Primary completion
- 2022-01-19
- Completion
- 2023-07-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 10 mg/kg | Intravenous |
| Background | Carboplatin | Small molecule | 2 unknown | — |
| Background | Paclitaxel | Small molecule | 50 mg/m2 | — |