drugset
drugset / Trial / NCT02735239

Study of Anti-PD-L1 in Combination With Chemo(Radio)Therapy for Oesophageal Cancer

NCT02735239 ↗

Phase 1/2 Completed 73 enrolled Ludwig Institute for Cancer Research AstraZeneca · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, Phase 1/2 study to evaluate the safety of durvalumab (MEDI4736) in combination with oxaliplatin/capecitabine chemotherapy in metastatic/locally advanced oesophageal cancer (OC) and with neoadjuvant chemo(radio)therapy before surgery in operable OC. The immunotherapy will be given for a 4-week period before starting the standard chemo(radio)therapy, continuing durvalumab treatment once the chemotherapy starts. The study will include 2 phases, a safety run-in Phase 1 (Cohorts A1 and A2) and an expansion Phase 2 (Cohorts B, C, C-FLOT, D/D2).

Timeline

Start
2016-06-24
Primary completion
2022-06-16
Completion
2022-06-16

Publications

  • Background Bohnsack O, Hoos A, Ludajic K. Adaptation of the immune related response criteria: irRECIST. Ann Oncol. 2014 Sep;25(suppl 4):iv361-iv72 [Abstract 4958]. doi: 10.1093/annonc/mdu342.23.

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 750 mg Intravenous
Subject Tremelimumab Monoclonal antibody 37.5 mg Intravenous
Subject Tremelimumab Monoclonal antibody 75 mg Intravenous
Background Capecitabine Small molecule 1250 mg/m2 Oral
Background Carboplatin Small molecule 2 unknown Intravenous
Background Docetaxel Small molecule 50 mg/m2 Intravenous
Background Leucovorin Small molecule 200 mg/m2 Intravenous
Background Oxaliplatin Small molecule 85 mg/m2 Intravenous
Background Oxaliplatin Small molecule 130 mg/m2 Intravenous
Background Paclitaxel Small molecule 50 mg/m2 Intravenous
Background fluorouracil Small molecule 2600 mg/m2 Intravenous

Indications

esophageal cancer