Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2 Positive Esophagogastric (EG) Cancer

Phase 2 Completed 37 enrolled Memorial Sloan Kettering Cancer Center

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to find out what effects, good and/or bad, pembrolizumab in combination with trastuzumab and chemotherapy, has on the patients' esophagogastric cancer.

Timeline

Start: 2016-11-03
Primary completion: 2022-06-01
Completion: 2023-03-14

Outcome

Met primary endpoint

paper The primary endpoint was achieved; 26 (70%; 95% CI 54-83) of 37 patients were progression-free at 6 months. PMID 32437664 ↗

Publications

Janjigian YY, Maron SB, Chatila WK, Millang B, Chavan SS, Alterman C, Chou JF, Segal MF, Simmons MZ, Momtaz P, Shcherba M, Ku GY, Zervoudakis A, Won ES, Kelsen DP, Ilson DH, Nagy RJ, Lanman RB, Ptashkin RN, Donoghue MTA, Capanu M, Taylor BS, Solit DB, Schultz N, Hechtman JF. First-line pembrolizumab and trastuzumab in HER2-positive oesophageal, gastric, or gastro-oesophageal junction cancer: an open-label, single-arm, phase 2 trial. Lancet Oncol. 2020 Jun;21(6):821-831. doi: 10.1016/S1470-2045(20)30169-8. Epub 2020 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous
Background	Capecitabine	Small molecule	850 mg/m2	Oral
Background	Cisplatin	Other / unclassified	80 mg/m2	—
Background	Oxaliplatin	Small molecule	104 mg/m2	Intravenous
Background	Oxaliplatin	Small molecule	130 mg/m2	Intravenous
Background	fluorouracil	Small molecule	800 mg/m2	Intravenous