An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

Summary

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

Timeline

Start

2016-07-14

Primary completion

2020-05-12

Completion

2024-11-07

Outcome

Met primary endpoint

registry analysis (superiority test); Nivolumab vs Placebo; p = 0.0003; Hazard Ratio (HR) 0.69 (96.4% CI 0.56 to 0.86); Stratified log-rank test NCT02743494 ↗

paper disease-free survival was significantly longer among those who received nivolumab adjuvant therapy than among those who received placebo. PMID 33789008 ↗

Publications

• Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lievre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	480 mg	—

Indications