Fianlimab + Cemiplimab Versus Pembrolizumab In Patients With Completely Resected High-Risk melanoma

• Research type

  Research Study

• Full title

  A PHASE 3 TRIAL OF FIANLIMAB (ANTI-LAG-3) AND CEMIPLIMAB VERSUS PEMBROLIZUMAB IN THE ADJUVANT SETTING IN PATIENTS WITH COMPLETELY RESECTED HIGH-RISK MELANOMA

• IRAS ID

  1006864

• Contact name

  Derrick Bramble

• Contact email

  derrick.bramble@regeneron.com

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Clinicaltrials.gov Identifier

  NCT05608291

• Research summary

  This study will look at how effective an experimental combination of study drugs (fianlimab & cemiplimab) is compared to an approved drug called pembrolizumab in people who have had skin cancer (cutaneous melanoma) surgically removed but remain at high risk of the skin cancer returning.
  Cutaneous melanoma is one of the most aggressive forms of skin cancer & the amount of people to suffer from the disease has continued to rise over the past 40 years. It accounts for the majority of skin cancer-related deaths.
  Most patients with newly diagnosed skin cancer are able to have it surgically removed & are potentially cured,however,the 5-year survival rate of these patients following surgery depends on the stage of disease at diagnosis.
  Despite recent advances in treatment,in approx 40% of patients the disease returns & for 25% it returns to other parts of the body following surgery which intends to cure the disease. Thus,more options are needed for the treatment of resectable melanoma to improve patients survival rates without the disease recurring,also known as relapse free survival or RFS.
  In view of the significant risk of disease recurrence,there is a strong clinical rationale for further treatment following the surgery with the aim of improving RFS & distant metastasis-free survival for patients with high-risk disease.
  Therefore,identifying additional effective treatment regimens for patients following surgery is of key importance for prolonging survival in people with skin cancer.
  This study will include about 1530 participants across 200 sites worldwide. NHS sites will undertake the study in the UK.
  Participants must be 12 years + with Stage IIC,III,or IV skin cancer & who have had surgery to completely remove their cancer.
  Patient participation will last up to 5 years & will involve:
  - Intravenous infusions
  - CT &/or MRI scans
  - Brain scans
  - Questionnaires
  - Physical examinations
  - Electrocardiograms
  - Blood tests
  - Urine test
  - Tumour biopsy

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  23/NW/0047

• Date of REC Opinion

  28 Sep 2023

• REC opinion

  Further Information Favourable Opinion