A Study of Avutometinib (VS-6766) and Defactinib in People With Mesonephric Gynecologic Cancer (NCT05787561) | Clinical Trial Compass
RecruitingPhase 2
A Study of Avutometinib (VS-6766) and Defactinib in People With Mesonephric Gynecologic Cancer
United States40 participantsStarted 2023-03-15
Plain-language summary
This study will test if Avutometinib (VS-6766) in combination with Defactinib is an effective treatment for advanced or recurrent mesonephric gynecologic cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Female patients ≥ 18 years of age
* Histologic confirmation of Gynecologic Mesonephric or Mesonephric-like cancer (GMC). Patients with mixed histology are eligible if the disease is deemed by the treating physician to be driven by the GMC component.
* Measurable disease according to RECIST 1.1
* Patients must have persistent (disease that is metastatic at presentation or remains present following first-line therapy) or recurrent disease (disease that has come back or progressed following prior surgery or treatment)
* Patients with metastatic or recurrent disease do not require any prior systemic therapy prior to enrollment. Patients may have received unlimited lines of prior systemic therapy.
* Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression. Patients with asymptomatic brain metastases that do not require intervention are also eligible.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
* Patients with a prior o…