Lenvatinib plus Pembrolizumab to Treat Advanced Endometrial Cancer
Research type
Research Study
Full title
A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination with Pembrolizumab Versus Treatment of Physician’s Choice in Participants with Advanced Endometrial Cancer
IRAS ID
244737
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
Eisai Ltd
Eudract number
2017-004387-35
Duration of Study in the UK
3 years, 6 months, 0 days
Research summary
Endometrial cancer (EC) is the fifth most common cancer in women worldwide, with approximately 320,000 new cases diagnosed in 2012. Most cases are identified at an early stage with a 5-year survival rate of 95.3% for EC that has not spread. However, approximately 13% of all EC recur and for patients with advanced or recurrent EC, the average survival is only approximately 12 months.\n\nProgrammed 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 become exhausted or die thus stopping them from attacking the cancer. The study drug pembrolizumab has been developed to block PD1/PDL1 interaction, thereby increasing the immune attack on cancers.\n\nLenvatinib is another study drug that works by blocking proteins called Vascular Endothelial Growth Factors which cancer cells can use to help themselves grow. Studies have shown that the use of lenvatinib can also help increase the immune attack on cancers, therefore the combination of pembrolizumab and lenvatinib could provide an effective treatment for EC.\n\nThis phase III study will last approximately 3.5 years (2 years treatment; 1.5 years follow-up) and will recruit approximately 780 female participants aged 18 years or over with advanced EC. The purpose of the study is to evaluate the effectiveness and safety of pembrolizumab given in combination with lenvatinib, versus the physician’s choice of chemotherapy (doxorubicin or paclitaxel). Participants will be assigned randomly in a 1:1 ratio to one of the two groups of the trial.\n \nThe study is sponsored by Eisai and funded by Merck Sharp & Dohme Limited. It will take place at 9 study centres in UK.\n
Lay summary of study results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT03517449%253Ftitles%253D775%2526rank%253D1%2526tab%253Dresults%2523results-overview%2FNBTI%2FjIXDAQ%2FAQ%2F0357261c-c4dd-4874-bb98-205712051158%2F3%2FJfmsXfF3of%23results-overview&data=05%7C02%7Clondonsoutheast.rec%40hra.nhs.uk%7C6bfe5bdb00be42419fdb08de7045cfa4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639071642308129476%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=6a%2B6dXrd3WkDpLrPFXuOd4rrjfDmSxurIYJz6UeoTQY%3D&reserved=0
REC name
London - South East Research Ethics Committee
REC reference
18/LO/0995
Date of REC Opinion
20 Jul 2018
REC opinion
Further Information Favourable Opinion