Study of Pembrolizumab (MK-3475) Versus Investigator's Choice of Chemotherapy for Participants With Advanced Esophageal/Esophagogastric Junction Carcinoma That Progressed After First-Line Therapy (MK-3475-181/KEYNOTE-181)-China Extension Study

Summary

In the China extension study, Chinese participants with advanced or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or Siewert type I adenocarcinoma of the esophagogastric junction (EGJ) that has progressed after first-line standard therapy will be randomized to receive either single agent pembrolizumab or the Investigator's choice of chemotherapy with paclitaxel, docetaxel, or irinotecan. The primary extension study hypothesis is that treatment with pembrolizumab will prolong overall survival (OS) as compared to treatment with chemotherapy.

Timeline

Start

2016-12-29

Primary completion

2019-02-13

Completion

2022-03-14

Outcome

Met primary endpoint

registry analysis (superiority test); Pembrolizumab vs Chemotherapy; p = 0.0015; Hazard Ratio (HR) 0.55 (95% CI 0.36 to 0.82); Log Rank NCT03933449 ↗

registry analysis (superiority test); Pembrolizumab vs Chemotherapy; p = 0.0008; Hazard Ratio (HR) 0.34 (95% CI 0.17 to 0.69); Log Rank NCT03933449 ↗

registry analysis (superiority test); Pembrolizumab vs Chemotherapy; p = 0.0021; Hazard Ratio (HR) 0.55 (95% CI 0.37 to 0.83); Log Rank NCT03933449 ↗

Publications

• Results Cao Y, Qin S, Luo S, Li Z, Cheng Y, Fan Y, Sun Y, Yin X, Yuan X, Li W, Liu T, Hsu CH, Lin X, Kim SB, Kojima T, Zhang J, Lee SH, Bai Y, Muro K, Doi T, Bai C, Gu K, Pan HM, Bai L, Yang JW, Cui Y, Lu W, Chen J. Pembrolizumab versus chemotherapy for patients with esophageal squamous cell carcinoma enrolled in the randomized KEYNOTE-181 trial in Asia. ESMO Open. 2022 Feb;7(1):100341. doi: 10.1016/j.esmoop.2021.100341. Epub 2021 Dec 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous
Comparator	Irinotecan	Small molecule	180 mg/m2	Intravenous
Comparator	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Comparator	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

Indications