Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05787561

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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