Avelumab + Paclitaxel/ Ramucirumab (RAP) as Second Line Treatment in Gastro-esophageal Adenocarcinoma

Summary

Avelumab + Paclitaxel/ Ramucirumab as second line treatment in gastro-esophageal adenocarcinoma following first-line therapy with platinum and fluoropyrimidine doublet with or without anthracycline, docetaxel or trastuzumab

Timeline

Start

2019-04-01

Primary completion

2022-09

Completion

2023-09

Outcome

Met primary endpoint

paper The OS rate at 6 months was 71.2% (95% CI, 61.5%-83.7%). PMID 38261316 ↗

paper a promising candidate with an OS rate of 65% or greater. PMID 38261316 ↗

Publications

• Background Doi T, Iwasa S, Muro K, Satoh T, Hironaka S, Esaki T, Nishina T, Hara H, Machida N, Komatsu Y, Shimada Y, Otsu S, Shimizu S, Watanabe M. Phase 1 trial of avelumab (anti-PD-L1) in Japanese patients with advanced solid tumors, including dose expansion in patients with gastric or gastroesophageal junction cancer: the JAVELIN Solid Tumor JPN trial. Gastric Cancer. 2019 Jul;22(4):817-827. doi: 10.1007/s10120-018-0903-1. Epub 2018 Dec 4.
• Thuss-Patience P, Hogner A, Goekkurt E, Stahl M, Kretzschmar A, Gotze T, Stocker G, Reichardt P, Kullmann F, Pink D, Bartels P, Jarosch A, Hinke A, Schultheiss C, Paschold L, Stein A, Binder M. Ramucirumab, Avelumab, and Paclitaxel as Second-Line Treatment in Esophagogastric Adenocarcinoma: The Phase 2 RAP (AIO-STO-0218) Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352830. doi: 10.1001/jamanetworkopen.2023.52830.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avelumab	Monoclonal antibody	1 mg/kg	—
Subject	Paclitaxel	Small molecule	80 mg/m2	—
Subject	Ramucirumab	Monoclonal antibody	8 mg/kg	—

Indications