A Study of SC Nivo + Rela FDC in prev. untreated Metastatic or Unresectable Melanoma

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Open-label, Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination versus Intravenous Nivolumab + Relatlimab Fixed-dose Combination in Participants with Previously Untreated Metastatic or Unresectable Melanoma

• IRAS ID

  1007052

• Contact name

  Head of the Global Submission Management - Clinical Trials

• Contact email

  mg-gsm-ct@bms.com

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Clinicaltrials.gov Identifier

  NCT05625399

• Research summary

  Researchers hope to learn more about different ways (injecting under the skin versus given directly into a vein) to give the same study drug. For this study, a combination of two drugs (antibodies) called nivolumab and relatlimab that work in different ways allowing your immune system to fight against cancer cells will be given. The primary objective of this study is to look at how much the study drug will be taken up (absorbed) in your body when given under your skin (subcutaneously) and if we will get comparable drug levels in the blood with this route, versus given directly into a vein (intravenously). These two ways of giving the drug will also be compared for how safe and effective they are.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  23/NW/0078

• Date of REC Opinion

  29 Sep 2023

• REC opinion

  Further Information Favourable Opinion