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

Recruiting now · Phase 3

Conditions studied: Low Grade Serous Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT06072781

Run by

Verastem, Inc.

People needed

270

Starts

2024-03-18

Expected to finish

2031-02-09

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients may be eligible for inclusion in the study if they meet the following criteria:
• Histologically proven LGSOC (ovarian, fallopian, peritoneal)
• Documented mutational status of KRAS by a validated tumor-tissue based diagnostic test.
• Suitable for treatment with at least one of the Investigator's Choice of Treatments:pegylated liposomal doxorubicin, paclitaxel, letrozole, anastrozole.
• 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, a negative pregnancy test must be confirmed and agreement to use highly effective method of contraceptive.
• Willingness to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.

You may not qualify if…

• 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 serous ovarian cancer or mixed 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, minor surgery within 1 week, or palliative radiotherapy within 1 week of the first dose of study intervention.
• Symptomatic brain metastases requiring steroids or other interventions, known leptomeningeal metastases, or spinal cord compression.
• An active skin disorder that has required systemic therapy within one year of the first dose of study intervention.
• History of medically significant rhabdomyolysis.
• For subjects with prior MEK or RAF exposure, Grade 4 toxicity is deemed related to the MEK inhibitor.
• Symptomatic bowel obstruction within 3 months of the first dose of study intervention
• Concurrent ocular disorders.
• Concurrent heart disease or severe obstructive pulmonary disease.
• Active or past medical history of interstitial lung disease/pneumonitis, including drug-induced or radiation pneumonitis, pulmonary fibrosis, or adult respiratory distress syndrome (ARDS).
• Subjects with the inability to swallow oral medications.
• History of hypersensitivity to any of the active agents or ingredients of study intervention: peanut, soya, polyoxyl castor oil, etcetc.). Prior hypersensitivity to anthracyclines or anthracenediones if the use of pegylated liposomal doxorubicin (PLD) is planned.
• Pregnant or breastfeeding.
• Active, uncontrolled infection (bacterial, viral, or fungal) requiring systemic therapy.

Where it is running

• HonorHealth — Phoenix, Arizona, United States (enrolling)
• UCLA Health — Los Angeles, California, United States (enrolling)
• University of Arkansas — Little Rock, Arkansas, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• Yale University — New Haven, Connecticut, United States (enrolling)
• Florida Cancer Specialists - South — Fort Myers, Florida, United States (enrolling)
• Mount Sinai — Miami Beach, Florida, United States (enrolling)
• UC Davis — Sacramento, California, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• Florida Cancer Specialists Research East — West Palm Beach, Florida, United States (enrolling)
• Winship Cancer Institute at Emory University — Atlanta, Georgia, United States (enrolling)
• NorthShore University HealthSystem — Evanston, Illinois, United States (enrolling)
• Louisiana State University — New Orleans, Louisiana, United States (enrolling)
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (enrolling)
• Karmanos Cancer Center — Detroit, Michigan, United States (enrolling)
• Minnesota Oncology Hematology — Minneapolis, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• AdventHealth — Orlando, Florida, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• Atrium Health — Charlotte, North Carolina, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Ohio State — Hilliard, Ohio, United States (enrolling)
• University of Oklahoma Medical Center — Oklahoma City, Oklahoma, United States (enrolling)
• Willamette Valley Cancer Institute — Eugene, Oregon, United States (enrolling)
• Northwest Cancer Specialists — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

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