About this trial

The purpose of this research is to test the effectiveness and safety of the study drugs (VS-6766 and defactinib), and see what effects (good and bad) these drugs have on the patients with endometrioid cancer, mucinous ovarian cancer, high-grade serous ovarian cancer, or solid gynecological cancer.

Eligibility criteria

Qualifiers

Female subjects ≥ 18 years of age.

Histologically proven gynecological cancers (endometrioid, MOC, HGSOC and solid gynecological cancers) with mutated RAS, BRAF (type I, II, and/or III), NF-1 loss of function, and/or RAS activation.

Mutational status will be taken from the previous next-gen sequencing (NGS) or molecular testing results and reviewed by the Principal Investigator prior to the start of treatment.

Adequate pathology material (as defined in the lab manual) must be available prior to treatment assignment to be used for confirmation.

Disqualifiers

Systemic anti-cancer therapy within 4 weeks of the first dose of study therapy.

Prior MEKi or RAFi exposure.

Low grade serous ovarian cancer (LGSOC).

History of prior malignancy with recurrence <3 years from the time of enrollment. Subjects with basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, and in situ cervical cancer that has undergone potentially curative therapy with no evidence of disease recurrence for ≥1 year since completion of the appropriate therapy may be included. Subjects with other malignancies associated with very low risk of metastasis or death may be included upon discussion with the PI.

Trial design

Treatments tested in this trial

  • Avutometinib (VS-6766) + defactinib

Treatment groups

55 Participants
are divided into 1 treatment group

Locations

4
AdventHealth32804, OrlandoFlorida, United States
Louisiana State University Medical Center New Orleans70112, New OrleansLouisiana, United States
University of New Mexico Comprehensive Cancer Center87131, AlbuquerqueNew Mexico, United States
Stephenson Cancer Center73117, Oklahoma CityOklahoma, United States

Sponsors and collaborators

University of Oklahoma

Lead sponsor

Verastem, Inc.

Collaborator