COLUMBUS-AD: phase III study of adjuvant encorafenib + binimetinib in resected stage IIB/IIC BRAF V600-mutated melanoma

Author:

van Akkooi Alexander CJ1ORCID,Hauschild Axel2ORCID,Long Georgina V3ORCID,Mandala Mario4ORCID,Kicinski Michal5ORCID,Govaerts Anne-Sophie5,Klauck Isabelle6,Ouali Monia7,Lorigan Paul C8ORCID,Eggermont Alexander MM910ORCID

Affiliation:

1. Melanoma Institute Australia, the University of Sydney & Royal Prince Alfred Hospital, 40 Rocklands Road Wollstonecraft, Sydney 2065, NSW, Australia

2. Department of Dermatology, University Hospital (UKSH), Arnold-Heller-Straße 3, 24105, Kiel, Germany

3. Melanoma Institute Australia, University of Sydney, & Mater & Royal North Shore Hospitals, 40 Rocklands Road Wollstonecraft, Sydney 2065, NSW, Australia

4. University of Perugia, Ospedale Santa Maria della Misericordia, Piazzale Giorgio Menghini, 3, 06129, Perugia, Italy

5. EORTC Headquarters, Avenue Emmanuel Mounier 83/11, 1200, Brussels, Belgium

6. Pierre Fabre, Medical & Patient/Consumer Division, 33 avenue Emile Zola, 92100, Boulogne-Billancourt, France

7. Pierre Fabre, Medical & Patient/Consumer Division, Langlade, France

8. Christie NHS Foundation Trust, Wilmslow Road Manchester M20 4BX, UK

9. University Medical Center Utrecht, Heidelberglaan 100, 3584 CX Utrecht, The Netherlands

10. Comprehensive Cancer Center Munich, Technical University Munich & Ludwig Maximiliaan University, Marchioninistraße 15, 81377 Munich, Germany

Abstract

Stage IIB/IIC melanoma has a high risk of recurrence after surgical resection. While, for decades, surgery was the only option for high-risk stage II disease in most countries, adjuvant therapies now exist. Anti-programmed cell death protein 1 (PD-1) antibodies significantly improve recurrence-free survival versus placebo in patients with fully resected stage IIB/IIC melanoma. Combined BRAF MEK inhibitor therapy showed benefits in high-risk stage III and advanced disease; however, its role in patients with fully resected stage BRAF-mutated IIB/IIC melanoma is still unknown. Here we describe the rationale and design of the ongoing randomized, placebo-controlled COLUMBUS-AD trial, the first study of a BRAF-MEK inhibitor combination therapy (encorafenib + binimetinib) in patients with BRAF V600-mutated stage IIB/IIC melanoma.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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