MAESTRA 2
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 2)
IRAS ID
1012974
Contact name
Aaron Packman
Contact email
Sponsor organisation
Incyte Corporation
Clinicaltrials.gov Identifier
Research summary
The goal of this study is to understand how effective and safe INCB123667 is compared to standard chemotherapy selected by the study doctor (paclitaxel, PLD, gemcitabine, or topotecan), in participants with ovarian cancer that overproduces cyclin E1, and who have received prior lines of platinum-based treatment and progressed quickly after their last treatment.
INCB123667 targets cyclin-dependent kinase 2 (CDK2), a protein that helps cells divide. In many cancers, CDK2 becomes too active due to high levels of cyclin E1, another protein that partners with CDK2 to drive cell growth. When cyclin E1 is overproduced, it can cause cells to grow and divide uncontrollably, leading to tumuor growth and making treatments less effective. By selectively blocking CDK2, INCB123667 may help slow cancer growth and improve treatment effectiveness.
Approximately 466 participants will be assigned in a 1:1 ratio into 1 of 2 treatment groups to receive either INCB123667 (Treatment Group A) or the study doctor’s choice of chemotherapy (Treatment Group B).
Participants receiving INCB123667 will take it by mouth twice daily in 28-day cycles. Participants receiving standard chemotherapy selected by the study doctor will receive treatment by intravenous infusion in either 28-day or 21-day cycles. All participants will remain on study treatment for as long as they are receiving benefit and have not met any conditions for stopping treatment.
Participants will have regular blood and urine tests, and their cancer will be monitored with imaging scans. Safety will be monitored from the time a participant signs the prescreening informed consent form, until 30 days after the last dose of study treatment is given, or until the start of a new anticancer treatment, whichever happens first.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
26/SC/0010
Date of REC Opinion
10 Feb 2026
REC opinion
Further Information Favourable Opinion