Combination Targeted and Hormonal treAtMEnt of Low-gradE Serous Ovarian Cancer in the upfroNt Setting

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: Memorial Sloan Kettering Cancer Center (other)

Phase: 2

Start date: April 29, 2024

Planned enrollment: 20

Trial ID: NCT06394804
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: Defactinib (PF-04554878, VS-6063)

chevron Show for: Avutometinib (RO-5126766, CKI-27, CH-5126766, R-7304, RG-7304, VS-6766)

TrialFetch AI Analysis

Goal: Assess the efficacy and safety of upfront avutometinib, defactinib, and letrozole for low-grade serous ovarian cancer (LGSOC).

Patients: Adults with histologically confirmed ovarian or peritoneal LGSOC, RECIST-measurable disease, and no prior systemic treatment for LGSOC or serous borderline disease. Eligible patients are not candidates for primary debulking or have measurable residual disease after attempted debulking. Most must have an ECOG performance status of 0–1; patients with a status of 2 may qualify if the impairment is cancer-related.

Design: Single-arm, nonrandomized phase 2 treatment study in the neoadjuvant setting or after suboptimal debulking. There is no control group.

Treatments: Avutometinib 3.2 mg orally twice weekly and defactinib 200 mg orally twice daily are given for three weeks followed by one week off in each 28-day cycle. Letrozole 2.5 mg is taken orally daily; premenopausal or perimenopausal patients with an ovary in situ also receive leuprolide for ovarian suppression. Avutometinib inhibits RAF–MEK signaling by stabilizing an inactive RAF–MEK complex, while defactinib inhibits FAK signaling that may enable adaptive resistance. In a prior phase 2 study of the two-drug combination in previously treated recurrent LGSOC, the objective response rate was 31% overall and 44% in KRAS-mutated disease. That evidence does not establish efficacy for this three-drug regimen in the upfront setting; letrozole adds endocrine therapy.

Outcomes: The primary outcome is RECIST v1.1 objective response rate, defined as complete or partial response, assessed over two years. The secondary outcome is adverse-event occurrence, graded using CTCAE v5.0 over two years.

Burden on patient: Moderate. Treatment involves multiple oral dosing schedules and, for some patients, recurring leuprolide injections. Response imaging, safety laboratory testing, and monitoring for cardiac and ocular risks are likely to require clinic visits. The protocol information does not specify visit or scan frequency, and no serial research biopsies or intensive pharmacokinetic blood draws are described.

Last updated: Sep 2026

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Sites (8)

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Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

No email / 404-778-3401

Status: Recruiting

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

No email / 646-888-4653

Status: Recruiting

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

No email / 646-888-4653

Status: Recruiting

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

No email / 646-888-4653

Status: Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

No email / 646-888-4653

Status: Recruiting

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

No email / 646-888-4653

Status: Recruiting

Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

No email / 646-888-4653

Status: Recruiting

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

No email / 646-888-4653

Status: Recruiting

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