Study of Nivolumab in Unresectable Advanced or Recurrent Esophageal Cancer

Phase 3 Completed 419 enrolled Ono Pharmaceutical Co., Ltd. Bristol-Myers Squibb · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of study is to evaluate the efficacy and safety of Nivolumab in unresectable advanced or recurrent esophageal cancer patients who have failed in standard chemotherapies.

Timeline

Start: 2015-12-14
Primary completion: 2020-10-23
Completion: 2020-10-23

Outcome

Met primary endpoint

paper overall survival was significantly improved in the nivolumab group compared with the chemotherapy group PMID 31582355 ↗

paper hazard ratio for death 0·77, 95% CI 0·62-0·96; p=0·019 PMID 31582355 ↗

Publications

Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y, Yen CC, Kubota Y, Kim SB, Hsu CH, Holtved E, Xynos I, Kodani M, Kitagawa Y. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019 Nov;20(11):1506-1517. doi: 10.1016/S1470-2045(19)30626-6. Epub 2019 Sep 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Nivolumab	Monoclonal antibody	240 mg	Intravenous
Comparator	Paclitaxel	Small molecule	100 mg/m2	Intravenous