FIANLIMAB + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC MELANOMA

• Research type

  Research Study

• Full title

  A PHASE 3 TRIAL OF FIANLIMAB (REGN3767, ANTI-LAG-3) + CEMIPLIMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED UNRESECTABLE LOCALLY ADVANCED OR METASTATIC MELANOMA

• IRAS ID

  1005325

• Contact name

  Lynsey Kennedy

• Contact email

  irasuk@iconplc.com

• Sponsor organisation

  Regeneron Pharmaceuticals, Inc.

• Eudract number

  2021-004453-23

• Clinicaltrials.gov Identifier

  NCT05352672

• Research summary

  This research study is looking at how effective an experimental combination of study drugs (fianlimab and cemiplimab) is in people with advanced melanoma skin cancer, compared with an approved drug called pembrolizumab. It is also looking to observe similarities or differences, in how the study drugs behave in adolescent participants (12 to 17 yrs inclusive) compared with adult participants (18 yrs and over).
  Cutaneous melanoma is a cancer that starts in the pigment-producing cells of the skin. It is one of the most aggressive forms of skin cancer and the amount of people to suffer from the disease has continued to rise over the past 40 years. Although often thought of as an adult disease, melanoma accounts for approximately 1% of cancers in children under 15 years of age.
  Although melanoma is much less common than other skin malignancies, it accounts for the majority of skin cancer-related deaths and in Europe it claims more than 20,000 lives annually.
  This study will include about 1100 participants across 200 sites worldwide. NHS sites will undertake the study in the UK.
  Eligible participants must be 12 years or older and they will have Stage III or Stage IV melanoma skin cancer which is previously untreated and is unable to be surgically removed.
  This is an event driven study whereby duration of therapy is until progression of disease, unacceptable toxicity, patient’s decision to leave, or the Investigator decides that it is not in the patient’s best interest to continue.
  Patient participation is estimated to last approx. 27 months for patients whose disease does not progress and approx. 96 months for final overall survival analysis. Patients will enter survival follow-up, which is anticipated to last up to 6 years, with quarterly follow-ups during this time.
  Patients will undergo:
  IV infusions
  CT and/or MRI scans
  Brain scans
  Photographs taken of the tumours
  Questionnaires
  Physical examinations
  ECGs
  Blood tests
  Urine test
  Tumour biopsies

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  22/LO/0319

• Date of REC Opinion

  13 Jun 2022

• REC opinion

  Further Information Favourable Opinion