Eligibility criteria-24 characters
[...] known tumor mutational burden ≥ 10 mutations/megabase (Mb).
No known RB1 mutations or two-copy RB1 deletion.
Participants must have just completed a minimum of 4 cycles and a maximum of 10 cycles of a combination of carboplatin, paclitaxel, and taxane or a combination of taxane and anti-PD-(L)1 inhibitor therapy (e.g., pembrolizumab, or dostarlimab, or durvalumab).
Participants must be considered appropriate to proceed with maintenance pembrolizumab monotherapy.
Participants must have had measurable stage III, measurable [...] s) after completion of their final dose of chemotherapy and pembrolizumab [...]
Secondary endpointsdetails revised at 1 of 3 entries
Study description-181 characters
This is a randomized, phase 2, single arm trial of maintenance letrozole + /abemaciclib vs. pembrolizumab after carboplatin + /paclitaxel + pembrolizumab chemotherapy with or without anti-PD-(L)1 blockade in participantspatients with advanced or recurrent estrogen receptor (ER) positive (ER+), mismatch repair proficient (MMRP), tumor protein p53 (TP53) wild-type endometrial cancer.
Participants will be randomized in one of two study groups: Abemaciclib + Letrozole vs. Pembrolizumab.
Randomization means that a participant is placed into a study group by chance.
The U.S. Food and Drug Administra [...] [...]
Study sitesdetails revised at 3 of 6 sites
Study title-17 characters
ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab