Phase 2 Study of V937 Plus Pembrolizumab
Research type
Research Study
Full title
A Phase 2, Randomized Clinical Study of Intravenous or Intratumoral Administration of V937 in Combination with Pembrolizumab (MK-3475) Versus Pembrolizumab Alone in Participants with Advanced/Metastatic Melanoma
IRAS ID
270818
Contact name
James Larkin
Contact email
Eudract number
2019-002034-36
Duration of Study in the UK
3 years, 6 months, 25 days
Research summary
Melanoma is the most serious form of skin cancer and strikes adults of all ages. There are approximately 11,000 deaths annually in the World Health Organisation (WHO) Europe region and the 5-year survival rate is 15% once patients have progressed to late stage disease.
Significant progress has been made in the field of immunotherapy to treat cancer, however, many advanced cancer patients do not respond to immunotherapy alone. There is a great unmet medical need for therapeutic agents that can enhance the effect of immunotherapy.
V937 is an oncolytic viral therapy developed to treat advanced cancers by preferentially infecting cancer cells. There is increasing evidence that suggests a viral infection within a tumour will cause an inflammatory response which may stimulate an immune response against a patient’s cancer.
Pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers. Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells meet cancer cells, PD1 becomes activated by programmed cell death ligands 1 and 2 (PDL1 and PDL2) which are proteins on the surface of cancer cells. The activated immune cells die thus stopping them from attacking the cancer.
The purpose of the study is to assess whether V937 in combination with pembrolizumab is superior to pembrolizumab alone in patients with melanoma.
The phase II study will last approximately 3 years and will recruit approximately 135 male/female participants aged 18 years or over. They will be randomly assigned into one of three treatment arms and will receive treatment in 21 cycles for approximately 2 years following an initial 28-day cycle.
The study is sponsored and funded by Merck Sharp & Dohme Limited (MSD). It will take place at 2 study centres in the UK.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1451
Date of REC Opinion
16 Sep 2019
REC opinion
Favourable Opinion