A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer
Summary
The MILO Study (MEK Inhibitor in Low-grade Serous Ovarian Cancer) is a Phase 3 study during which patients with recurrent or persistent low-grade serous (LGS) carcinomas of the ovary, fallopian tube or primary peritoneum will receive either investigational study drug MEK162 or a chemotherapy chosen by the physician (liposomal doxorubicin, paclitaxel or topotecan). Patients will be followed to compare the effectiveness of the study drug to that of the selected chemotherapies. Patients may be eligible to crossover from physician's choice chemotherapy to MEK162 if they meet certain inclusion criteria including centrally confirmed disease progression. Approximately 360 patients from North America, Europe and Australia will be enrolled in this study.
Timeline
- Start
- 2013-06-27
- Primary completion
- 2016-01-20
- Completion
- 2022-08-23
Outcome
Missed primary endpoint
Stopped (Enrollment): “Per recommendation of the DMC, enrollment into the study was discontinued in April 2016 after the planned interim efficacy analysis showed the hazard ratio for PFS crossed the predefined futility boundary.”
paper Although the MEK Inhibitor in Low-Grade Serous Ovarian Cancer Study did not meet its primary end point PMID 32822286 ↗
Publications
- Grisham RN, Vergote I, Banerjee S, Drill E, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Cibula D, Moore KN, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Kristensen G, Clamp A, Farley J, Iyer G, Ray-Coquard I, Monk BJ. Molecular Results and Potential Biomarkers Identified from the Phase 3 MILO/ENGOT-ov11 Study of Binimetinib versus Physician Choice of Chemotherapy in Recurrent Low-Grade Serous Ovarian Cancer. Clin Cancer Res. 2023 Oct 13;29(20):4068-4075. doi: 10.1158/1078-0432.CCR-23-0621.
- Monk BJ, Grisham RN, Banerjee S, Kalbacher E, Mirza MR, Romero I, Vuylsteke P, Coleman RL, Hilpert F, Oza AM, Westermann A, Oehler MK, Pignata S, Aghajanian C, Colombo N, Drill E, Cibula D, Moore KN, Christy-Bittel J, Del Campo JM, Berger R, Marth C, Sehouli J, O'Malley DM, Churruca C, Boyd AP, Kristensen G, Clamp A, Ray-Coquard I, Vergote I. MILO/ENGOT-ov11: Binimetinib Versus Physician's Choice Chemotherapy in Recurrent or Persistent Low-Grade Serous Carcinomas of the Ovary, Fallopian Tube, or Primary Peritoneum. J Clin Oncol. 2020 Nov 10;38(32):3753-3762. doi: 10.1200/JCO.20.01164. Epub 2020 Aug 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Binimetinib | Small molecule | 45 mg | Oral |
| Comparator | Doxorubicin | Other / unclassified | — | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | Intravenous |
| Comparator | Topotecan | Small molecule | — | Intravenous |