Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

4158 - CA224-047: A Randomized, Double-Blind, Phase 2/3 Study of Relatlimab (Anti–LAG-3) in Combination With Nivolumab (Anti–PD-1) Versus Nivolumab Alone in Previously Untreated Metastatic or Unresectable Melanoma

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Evan Lipson

Citation

Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289

Authors

E.J. Lipson1, G.V. Long2, H. Tawbi3, D. Schadendorf4, V.G. Atkinson5, M. Maurer6, K.L. Simonsen7, C. Harbison8, F..S. Hodi9

Author affiliations

  • 1 Medical Oncology, Johns Hopkins University, 21287 - Baltimore/US
  • 2 Melanoma Institute Australia, The University of Sydney Northern Clinical School and Royal North Shore Hospital, Sydney/AU
  • 3 Department Of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston/US
  • 4 Department Of Dermatology, University Hospital Essen, Essen/DE
  • 5 Gallipoli Medical Research Foundation, Greenslopes Private Hospital and University of Queensland, Brisbane/AU
  • 6 Oncology Development, Bristol-Myers Squibb, Princeton/US
  • 7 Global Biometric Sciences, Bristol-Myers Squibb, Princeton/US
  • 8 Translational Medicine, Bristol-Myers Squibb, Princeton/US
  • 9 Medical Oncology, Dana-Farber Cancer Institute, Boston/US
More

Resources

Abstract 4158

Background

Immune checkpoint inhibitors targeting the programmed death receptor1 (PD1) and cytotoxic Tlymphocyte antigen 4 (CTLA4) pathways have provided significant clinical benefit for patients with unresectable or metastatic melanoma. However, a proportion of patients may not respond or may progress with current therapies. Lymphocyteactivation gene 3 (LAG3) is an additional immune checkpoint pathway that negatively regulates effector Tcell function and is a marker of Tcell exhaustion. Dual checkpoint inhibition of the LAG3 and PD1 pathways, by relatlimab and nivolumab, respectively, showed clinical activity in patients with previously treated metastatic or unresectable melanoma whose disease progressed during prior anti–PD(L)1 therapy, with a safety profile similar to nivolumab monotherapy (Ascierto P, et al. Presented at the ESMO 2017 Congress; September 8–12, 2017; Madrid, Spain. Oral LBA18). CA224047 will assess the clinical efficacy and safety of relatlimab in combination with nivolumab versus nivolumab alone in previously untreated metastatic or unresectable melanoma.

Trial design

This is a randomized, multicenter, doubleblind, phase 2/3 study of relatlimab in combination with nivolumab versus nivolumab alone, in previously untreated metastatic or unresectable melanoma. Approximately 700 patients aged ≥12 years, with no prior systemic anticancer therapy for histologically confirmed stage III (unresectable) or stage IV (metastatic) melanoma and biopsy tissue available for biomarker analyses, are being randomized. Patients with active brain metastases or leptomeningeal metastases, or ocular melanoma are excluded. The primary endpoint for the phase 2 component is objective response rate, and for phase 3 is progressionfree survival. Other endpoints include overall survival, duration of response, disease control rate, and safety and tolerability. This study has started to enroll patients.

Clinical trial identification

NCT03470922.

Legal entity responsible for the study

Bristol-Myers Squibb.

Funding

Bristol-Myers Squibb.

Editorial Acknowledgement

Medical writing assistance was provided by Katerina Pipili, PhD, of Spark Medica Inc. (US), funded by Bristol-Myers Squibb.

Disclosure

E.J. Lipson: Research support: Bristol-Myers Squibb and Merck. Advisory board: Array BioPharma. G.V. Long: Consultancy services: Amgen, BMS, Merck MSD, Novartis, Roche, Pierre Fabre, Array. Honoraria: BMS, MSD, Roche, Novartis, Incyte. H. Tawbi: Research funding (institution): Merck, GlaxoSmithKline, Celgene; Research funding institution, Consulting fees: Bristol-Myers Squibb, Roche/Genentech. D. Schadendorf: Advisory board: BMS, Novartis, MSD, Sanofi, Regeneron, Incyte, Merck-Serono, Pfizer, Immunocore; Pierre Fabre, Roche; Corporate-sponsored research: BMS, Novartis. V.G. Atkinson: Advisory board: BMS, MSD, Novartis, Merck Serono, Pierre Fabre; Speakers fee: BMS, MSD, Roche, Novartis; Travel support: BMS, MSD. M. Maurer, K.L Simonsen, C. Harbison: Employee, Stock ownership: BMS. F.S. Hodi: Research support (institution): BMS; Consultant: BMS, Merck, Novartis, EMD Serono, Sanofi.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.