The researchers are doing this study to find out whether the combination of avutometinib, defactinib, and letrozole is an effective treatment for people with low-grade serous ovarian cancer (LGSOC). The researchers will also look at the safety of this combination.
Female patients ≥ 18 years of age
Histologically-confirmed LGSOC (ovarian, peritoneal) by tissue biopsy read by pathology at study institution. NOTE: Patients with a prior history of serous borderline tumors without prior systemic (cytotoxic or hormonal) treatment but a new diagnosis of low-grade serous ovarian cancer are eligible.
Determination that the patient is not a primary surgical candidate by a gynecologic oncologist surgeon; or has undergone an attempted primary debulking with residual RECIST measurable disease.
Measurable disease according to RECIST 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension. Each lesion must be ≥10mm when measured by CT or MRI. Lymph nodes must be ≥15mm by short axis when measured by CT or MRI.
Patients who are deemed in the opinion of their treating physician to be appropriate candidates for a primary debulking surgery are not eligible for this trial, unless measurable disease remains after a primary cytoreductive surgery.
Prior systemic anti-cancer therapy for LGSOC or serous borderline disease.
Major surgery within 4 weeks, minor surgery within 2 weeks, or palliative radiotherapy within 1 week of the first dose of study intervention. Open and close laparotomy and/or laparoscopy will be considered minor surgery.
Treatment with warfarin. Patients on warfarin for deep vein thrombosis/pulmonary embolism can be converted to low-molecular-weight heparin or direct oral anticoagulants (DOACs).
Single group
Avutometinib
DrugStarting Dose 3.2 mg BIW for 3 of 4 weeks, Dose -1, 2.4 mg BIW for 3 of 4 weeks
Defactinib
DrugStarting Dose 200 mg BID for 3 of 4 weeks, Dose -1, 200 mg QD for 3 of 4 weeks
Letrozole
Drug2.5 mg PO daily
objective response rate
as defined by complete response or partial response assessed by RECIST v1.1. in patients receiving neoadjuvant treatment or treatment for measurable disease following suboptimal debulking.
Occurrence of adverse events
as assessed by CTCAE (Common Terminology Criteria for Adverse Events) v.5.0.
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Verastem, Inc.
Collaborator
