Phase 2 Study of Pembrolizumab in Participants With R/M cSCC
Research type
Research Study
Full title
A Phase 2, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Pembrolizumab in Participants with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (R/M cSCC)
IRAS ID
228388
Contact name
Joseph Sacco
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-000594-37
Duration of Study in the UK
3 years, 0 months, 19 days
Research summary
The head and neck region is one of the most common area for cutaneous squamous cell carcinoma (cSCC) to develop because of the daily exposure to the sun’s ultraviolet rays. cSCC is the second most frequent non-melanoma skin cancer, currently representing approximately 20% of all non-melanoma skin cancers and 20% of all skin cancer deaths. Due to its ability to spread, when not cured by local treatment, cSCC could eventually result in death.
A lack of clinical trial data in patients with spreading (metastatic) and/or inoperable (unresectable) cSCC means there is no current standard of care treatment. Therefore, it is proposed to test the clinical activity of pembrolizumab for unresectable/metastatic cSCC, a disease with limited treatment options and a significant unmet clinical need.
Pembrolizumab is indicated for cancer treatment across many indications because of its mechanism of action to bind the PD-1 receptor on the T cell. Programmed cell death 1 (PD1) is a protein present on the surface of immune (attacking) cells which fight cancer. When immune cells come upon 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. Interaction between these ligands and the receptors present on the immune cells prevents the immune cells from attacking the cancer cells. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.
This is an open-label, non-randomised, single arm Phase 2 study of pembrolizumab therapy in approximately 120 male/female participants aged ≥18yrs with R/M cSCC who had a prior treatment with either a platinum or a cetuximab containing regimen. The trial will last approximately 50 months.
The study is funded by Merck Sharp & Dohme Limited and will take place at 5 study centres in the UK.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
17/NE/0234
Date of REC Opinion
9 Aug 2017
REC opinion
Further Information Favourable Opinion