Open Actively Recruiting

A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer


Brief Summary

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.

Primary Purpose
Study Type
Phase 3


Healthy Volunteers
Minimum Age
18 Years
Maximum Age

Inclusion Criteria:

Patients may be eligible for inclusion in the study if they meet the following criteria:

  • Histologically proven LGSOC (ovarian, fallopian, peritoneal)
  • Progression or recurrence of LGSOC after at least one prior systemic therapy for metastatic disease.
  • Measurable disease according to RECIST v1.1.
  • An Eastern Cooperative Group (ECOG) performance status ≤ 1.
  • Adequate organ function
  • Adequate recovery from toxicities related to prior treatments.
  • For patients with reproductive potential, Agreement to use highly effective method of contraceptive.
  • Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

  • Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.
  • Co-existing high-grade ovarian cancer or another histology.
  • Prior treatment with avutometinib, defactinib, or other FAK inhibitors.
  • History of prior malignancy with recurrence <3 years from the time of enrollment.
  • Major surgery within 4 weeks.
  • Symptomatic brain metastases or spinal cord compression.
  • An active skin disorder that has required systemic therapy within one year of signing informed consent.
  • History of medically significant rhabdomyolysis.
  • For subjects with prior MEK exposure, Grade 4 toxicity deemed related to the MEK inhibitor.
  • Symptomatic bowel obstruction within 3 months.
  • Concurrent ocular disorders.
  • Concurrent heart disease or severe obstructive pulmonary disease.
  • Subjects with the inability to swallow oral medications.
  • Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Join this Trial

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Study Stats
Protocol No.
Ovarian Cancer
Surya Nagesh
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
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