Adjuvant MK 7684A vs Pembrolizumab for Resected High-Risk Melanoma

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study of Adjuvant MK-7684A (Vibostolimab with Pembrolizumab) Versus Adjuvant Pembrolizumab in Participants with High-risk Stage II-IV Melanoma (KEYVIBE-010)

• IRAS ID

  1006835

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Melanoma is a cancerous tumour that accounts for less than 2% of skin cancers, yet 90% of deaths due to skin tumours are associated with melanoma. There is a high unmet need for new therapeutic options. Several worldwide health authorities have approved pembrolizumab for the treatment of adult and paediatric (>12 yrs) patients with Stage IIB, IIC, or III melanoma following surgery.
  Previous research has shown pembrolizumab provides significant and clinically meaningful reduction in the risk of disease recurrence or death in patients with high-risk disease. While pembrolizumab alone has shown an improvement, the combination therapy MK-7684A (vibostolimab with pembrolizumab) may be able to further improve these outcomes.
  This trial is testing MK-7684A versus pembrolizumab in patients who have had surgery to remove their high-risk melanoma. MK-7684A is an experimental combination drug that has not been approved to treat this type of cancer.
  About 1,560 male and female participants, aged 12 years and older, will take part in this trial.
  The duration of the trial will be approximately a year as long as the patient’s disease does not worsen, and the patient is tolerating the treatment.
  There is a screening phase, lasting about 4 weeks, to see if patients can join the trial.
  Eligible participants will be randomised 1:1 to receive treatment with either MK-7684A (Arm A) or pembrolizumab (Arm B) by intravenous [IV] infusion every 3 weeks for up to 17 cycles (up to 1 year). Randomisation will be determined according to the participant’s disease risk and by geographic region.
  After the participant stops taking the trial drug, they will enter the post-treatment follow up period. The participant will complete a site visit four weeks later and then every 12 weeks.
  The trial is sponsored by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  Wales REC 5

• REC reference

  22/WA/0364

• Date of REC Opinion

  29 Jun 2023

• REC opinion

  Further Information Favourable Opinion