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

Summary

Cancer - including esophageal squamous cell cancer (ESCC) - is a disease of the elderly but little is known about the biology and progression of cancers in these patients. While most patients receive chemotherapy and/or chemo-radiation as first treatment, no treatment standard for following treatments has been established so far and there is a clear unmet medical need, especially for elderly patients. Hence, this study assesses the efficacy and safety of two experimental immunotherapy regimens (Nivolumab monotherapy or Nivolumab/Ipilimumab combination) in elderly patients with advanced esophageal squamous cell cancer.

Timeline

Start

2018-02-21

Primary completion

2021-11-19

Completion

2021-11-19

Outcome

Met primary endpoint

paper significantly higher than in a historical cohort receiving standard chemotherapy (p=0·0063). PMID 36098320 ↗

Publications

• Li M, Meindl-Beinker NM, Maenz M, Betge J, Schulte N, Zhan T, Hofheinz RD, Vogel A, Angermeier S, Bolling C, de Wit M, Jakobs R, Karthaus M, Stocker G, Thuss-Patience P, Leidig T, Bauer H, Ebert MP, Haertel N. Functional status and quality of life in older patients with advanced esophageal squamous cell cancer receiving second-line nivolumab +/- ipilimumab therapy: A post hoc analysis of the phase 2, multicenter RAMONA study. J Geriatr Oncol. 2024 Sep;15(7):101838. doi: 10.1016/j.jgo.2024.101838. Epub 2024 Aug 3.
• Ebert MP, Meindl-Beinker NM, Gutting T, Maenz M, Betge J, Schulte N, Zhan T, Weidner P, Burgermeister E, Hofheinz R, Vogel A, Angermeier S, Bolling C, de Wit M, Jakobs R, Karthaus M, Stocker G, Thuss-Patience P, Leidig T, Gaiser T, Kather JN, Haertel N. Second-line therapy with nivolumab plus ipilimumab for older patients with oesophageal squamous cell cancer (RAMONA): a multicentre, open-label phase 2 trial. Lancet Healthy Longev. 2022 Jun;3(6):e417-e427. doi: 10.1016/S2666-7568(22)00116-7. Epub 2022 Jun 9.
• Meindl-Beinker NM, Betge J, Gutting T, Burgermeister E, Belle S, Zhan T, Schulte N, Maenz M, Ebert MP, Haertel N. 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. 2019 Mar 14;19(1):231. doi: 10.1186/s12885-019-5446-2.

Drugs

Indications