Carcinosarcoma of Ovary Clinical Trial
Official title:
A Phase II Single Arm Study of Cabozantinib Plus Nivolumab and Ipilimumab in Women With Recurrent Gynecologic Carcinosarcoma
The purpose of this study is to test the safety of Cabozantinib in combination with Nivolumab and Ipilimumab and see what affects that this combination treatment has on those with recurrent carcinosarcomas.
Primary Objectives: • To estimate the proportion of patients with recurrent carcinosarcoma, who survive progression-free for at least 6 months, treated with cabozantinib + nivolumab + ipilimumab in the second-line and beyond setting (per iRECIST). Secondary Objectives: - To evaluate time to progression (Time Frame: From the date the patient received the first study treatment dose until the date of first documented progression, assessed up to 2 years). Progression Free Survival (PFS) according to iRECIST. - To determine the nature and degree of toxicity of cabozantinib + nivolumab + ipilimumab in this cohort of patients. Toxicity according to CTCAE v4.03 - To estimate the overall survival (OS) of patients with carcinosarcoma treated with cabozantinib + nivolumab + ipilimumab Exploratory Objectives: - To determine expression of biomarkers, which will include PD-L1 and MET expression by IHC, MSI status by NGS, and other relevant potential biomarkers. - To determine whether these marker expression levels alone or in combination are associated with response, PFS, and/or overall survival. ;