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
Sponsors and collaborators
University of Oklahoma
Lead sponsor
Verastem, Inc.
Collaborator