Actively Recruiting
A Study of Avutometinib (VS-6766) and Defactinib in People With Mesonephric Gynecologic Cancer
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-28
40
Participants Needed
7
Research Sites
206 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
V
Verastem, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will test if Avutometinib (VS-6766) in combination with Defactinib is an effective treatment for advanced or recurrent mesonephric gynecologic cancer.
CONDITIONS
Official Title
A Study of Avutometinib (VS-6766) and Defactinib in People With Mesonephric Gynecologic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients 18 years of age or older
- Histologic confirmation of gynecologic mesonephric or mesonephric-like cancer
- Measurable disease according to RECIST 1.1
- Persistent metastatic or recurrent disease
- No limit on prior systemic therapy lines; prior therapies allowed
- Treated brain metastases with no progression or asymptomatic brain metastases not requiring intervention
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
- Undetectable HBV viral load on suppressive therapy if chronic hepatitis B infection
- Treated and cured hepatitis C infection or currently on treatment with undetectable HCV viral load
- Prior or concurrent malignancy allowed if not interfering with safety or efficacy
- Resolution of prior therapy or surgery toxicities to baseline or Grade 1 (except certain conditions)
- Agreement to use highly effective non-hormonal contraception during and for 1 month after study
- Adequate cardiac function with left ventricular ejection fraction ≥ 55%
- Baseline QTc interval < 460 ms (except for bundle branch block)
- Adequate organ function with specified liver, kidney, muscle enzyme, and blood count levels
You will not qualify if you...
- Newly diagnosed localized disease or candidates for curative surgery or radiation
- Systemic anti-cancer therapy (except endocrine) within 4 weeks before first study dose
- Endocrine therapy within 1 week before first study dose
- Major surgery within 4 weeks, minor surgery within 2 weeks, or palliative radiotherapy within 1 week before first study dose
- Treatment with warfarin (except if converted to other anticoagulants)
- Prior treatment with MEK, RAF, or FAK inhibitors
- Inability to swallow oral medications or impaired gastrointestinal absorption
- History or evidence of retinal or serious ocular pathology increasing risk for retinal vein occlusion
- History of corneal erosion, degeneration, active/recurrent keratitis, or serious ocular surface inflammation
- History of rhabdomyolysis
- Hypersensitivity to any ingredients of Avutometinib or Defactinib
- Any medical condition posing unacceptable risk for toxicity as judged by the investigator
- Use of medications, supplements, or foods with potential drug interactions with study drugs within 14 days before and during treatment including strong CYP3A4, CYP2C9, P-glycoprotein, or BCRP inhibitors or inducers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk -Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
R
Rachel Grisham, MD
CONTACT
C
Carol Aghajanian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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