PROMPT
Research type
Research Study
Full title
Phase II trial of maintenance pembrolizumab following weekly paclitaxel for recurrent ovarian, fallopian tube or peritoneal cancer
IRAS ID
236285
Contact name
Jonathan Ledermann
Contact email
Sponsor organisation
University College London Hospitals NHS Foundation Trust
Eudract number
2017-003792-63
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Ovarian cancer occurs in about 1 of 52 women in the UK. There are approximately 7,300 cases each year and it is the 5th most common cause of cancer death in women. The 5 year survival rate is 19% for stage III and 3% for stage IV ovarian cancer. \n\nFallopian tube and non-mucinous primary peritoneal cancer are treated in a similar way to ovarian cancer and this usually comprises surgery and chemotherapy. Most patients will respond to treatment but the median progression-free survival is approximately 18 months. The outlook for women receiving non-platinum based therapies is poor; responses to chemotherapy are less frequent and usually short-lived. The expected median progression-free survival (PFS) of 3-4 months in women with recurrent ovarian cancer, and a median overall survival of about one year. In the UK Pegylated Liposomal Doxorubicin (PLD) or weekly paclitaxel is commonly used in this group. \n\nThis study will investigate the effect of maintenance pembrolizumab in patients who have undergone treatment with weekly paclitaxel for recurrent ovarian cancer and have either responded or have not progressed after a minimum of 4 cycles of treatment. This approach has been selected for two main reasons: firstly, maintenance pembrolizumab may build on the response to paclitaxel; secondly, chemotherapy prior to pembrolizumab may provide a better immune environment for pembrolizumab. In this study patients will receive 3 weekly pembrolizumab until progression and we will monitor the immune microenvironment by tumour biopsy and blood sampling before starting pembrolizumab and again before cycle 4 of treatment.\n\nThe maintenance regimen may be continued even if the disease has worsened, as indicated by CT scan, if the clinician believes the patient is still deriving benefit. Trial treatment must be discontinued if further cancer treatment is started. Patients can receive pembrolizumab for a maximum of 2 years if the disease hasn’t worsened and they are no longer deriving benefit. \n\nPROMPT will be undertaken in the UK in approximately 3 sites. The target accrual is 28 patients.\n
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
18/EE/0300
Date of REC Opinion
19 Oct 2018
REC opinion
Further Information Favourable Opinion