MONETTE
Research type
Research Study
Full title
MONETTE: A Randomised, Open-Label, Phase 2 Study of Ceralasertib Monotherapy and Ceralasertib plus Durvalumab in Patients with Unresectable or Advanced Melanoma and Primary or Secondary Resistance to PD-(L)1 Inhibition
IRAS ID
1004026
Contact name
Lynne Jordan
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-001722-21
Research summary
Melanoma is the most serious form of skin cancer and the fifth most frequently diagnosed cancer in the UK. Around 16,000 new cases of melanoma are diagnosed and more than 2,300 people die every year from melanoma in the UK. The incidence of melanoma is increasing each year. The main treatment for melanoma is surgery. If melanoma is not diagnosed until an advanced stage, treatment is mainly used to slow the spread of the cancer and reduce symptoms. This usually involves medicines that target specific genetic changes in the melanoma, or medicines that boost the body's immune responses to the melanoma.
This study will test if ceralasertib given alone (monotherapy) and in combination with durvalumab is safe and effective for treating patients with unresectable or advanced melanoma, and also to better understand the disease and associated health problems. Ceralasertib, an experimental medication, is a selective inhibitor of a specific protein (ATR kinase) in different solid and haematologic cancers. Durvalumab is a PD-(L)1 inhibitor which has been shown to be effective in other cancer types. PD- (L)1 is a protein that acts as a kind of “brake” to keep the body’s immune responses under control.
Participants assigned to receive ceralasertib monotherapy will receive ceralasertib by mouth twice a day, from Day 1 to 14 of each cycle lasting 28 days. If participants are assigned to receive ceralasertib and durvalumab, durvalumab will be given on Day 1 via a slow injection into a vein once per 28-day cycle and ceralasertib by mouth twice a day from Day 15 to 28 of each 28-day cycle. Participants will have a minimum of 20 study visits over the first 12 months of the study and may continue treatment in the study as long as they tolerate the treatment and the doctor considers that they are benefitting from the treatment.
Approximately 200 patients will take part in this study.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
21/NW/0283
Date of REC Opinion
8 Nov 2021
REC opinion
Further Information Favourable Opinion