title: A multicenter open-label phase II trial to evaluate nivolumab and ipilimumab for 2nd line therapy in elderly patients with advanced esophageal squamous cell cancer (RAMONA)
creator: Meindl-Beinker, Nadja M.
creator: Betge, Johannes
creator: Gutting, Tobias
creator: Burgermeister, Elke
creator: Belle, Sebastian
creator: Zhan, Tianzuo
creator: Schulte, Nadine
creator: Maenz, Martin
creator: Ebert, Matthias P.
creator: Haertel, Nicolai
subject: ddc-610
subject: 610 Medical sciences Medicine
description: Background: Advanced esophageal squamous cell cancer (ESCC) is frequently diagnosed in elderly patients. The impact of 2nd line chemotherapy is poorly defined. Recent data demonstrated effectiveness of checkpoint inhibitors in different squamous cell carcinomas. Therefore, we assess combined nivolumab/ipilimumab as 2nd line therapy in elderly ESCC patients.    Methods: RAMONA is a multicenter open-label phase II trial. The primary objective is to demonstrate a significant survival benefit of nivolumab/ipilimumab in advanced ESCC compared to historical data of standard chemotherapy. Primary endpoint is therefore overall survival (OS). Major secondary objective is the evaluation of tolerability. Time to QoL deterioration will thus be determined as key secondary endpoint. Further secondary endpoints are tumor response, PFS and safety. We aim to recruit a total of n = 75 subjects that have to be > 65 years old. Eligibility is determined by the geriatric status (G8 screening and Deficit Accumulation Frailty Index (DAFI)). A safety assessment will be performed after a 3 cycle run-in phase of nivolumab (240 mg Q2W) to justify escalation for eligible patients to combined nivolumab (240 mg Q2W) and ipilimumab (1 mg/kg Q6W), while the other patients will remain on nivolumab only. RAMONA also includes translational research sub-studies to identify predictive biomarkers, including PD-1 and PD-L1 evaluation at different time points, establishment of organoid cultures and microbiome analyses for response prediction.    Discussion: The RAMONA trial aims to implement checkpoint inhibitors for elderly patients with advanced ESCC as second line therapy. Novel biomarkers for checkpoint-inhibitor response are analyzed in extensive translational sub-studies.    Trial registration: EudraCT Number 2017–002056-86; NCT03416244,   registered: 31.1.2018.
publisher: BioMed Central ; Springer
date: 2019
type: Article
type: info:eu-repo/semantics/article
type: NonPeerReviewed
format: application/pdf
identifier: https://archiv.ub.uni-heidelberg.de/volltextserverhttps://archiv.ub.uni-heidelberg.de/volltextserver/26184/1/12885_2019_Article_5446.pdf
identifier: DOI:
identifier: urn:nbn:de:bsz:16-heidok-261845
identifier:   Meindl-Beinker, Nadja M. ; Betge, Johannes ; Gutting, Tobias ; Burgermeister, Elke ; Belle, Sebastian ; Zhan, Tianzuo ; Schulte, Nadine ; Maenz, Martin ; Ebert, Matthias P. ; Haertel, Nicolai  (2019) A multicenter open-label phase II trial to evaluate nivolumab and ipilimumab for 2nd line therapy in elderly patients with advanced esophageal squamous cell cancer (RAMONA).  BMC Cancer, 19 (231).  pp. 1-8.  ISSN 1471-2407     
relation: https://archiv.ub.uni-heidelberg.de/volltextserver/26184/
rights: info:eu-repo/semantics/openAccess
rights: Please see front page of the work (Sorry, Dublin Core plugin does not recognise license id)
language: eng