ARTISTRY-7
Research type
Research Study
Full title
A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)
IRAS ID
1005189
Contact name
Elizabeth Keane
Contact email
Sponsor organisation
Alkermes, Inc.
Eudract number
2021-002326-24
Clinicaltrials.gov Identifier
Research summary
This research study is investigating the use of an experimental drug called nemvaleukin as a potential treatment for epithelial ovarian, fallopian tube or primary peritoneal cancer. Nemvaleukin is a modified (manmade) molecule that has the potential of increasing the body’s immune (protective) system to destroy cancer cells. This main purpose of this study is to learn if treatment with nemvaleukin alone, or in combination with another drug (called “pembrolizumab”) is effective in treating the types of cancers listed above. The study will also determine how safe the study drug is. This will be done by studying the way the body processes the study drug, how participants’ disease responds to the study drug and the body’s immune response to the study drug. Approximately 376 people are expected to take part in the study at around 70 sites globally. The study will involve 4 treatment arms which participants will be randomly assigned to. Arm 1 is treatment with nemvaleukin and pembrolizumab, Arm 2 is pembrolizumab alone, Arm 3 is nemvaleukin alone and Arm 4 is chemotherapy treatment that will be chosen by the study doctor. At the end of treatment, final tests and exams will be performed and the participants will be followed for up to 3 years after their first dose of treatment, or until closure of the study, whichever comes first.
REC name
Wales REC 3
REC reference
22/WA/0248
Date of REC Opinion
5 Dec 2022
REC opinion
Further Information Favourable Opinion