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A Multicenter Phase II Trial of Paclitaxel With and Without Nivolumab in Taxane Naive, and Nivolumab and Cabozantinib in Taxane Pretreated Subjects With Angiosarcoma
Co-primary Objectives
To determine the progression free survival (PFS) for paclitaxel with and without nivolumab in subjects with taxane naïve angiosarcoma.
To determine the overall response rate (ORR) of nivolumab in combination with cabozantinib in patients with taxane pre-treated angiosarcoma.
Secondary objectives
to determine the ORR of paclitaxel in combination with nivolumab.
To determine clinical activity of the addition of nivolumab to paclitaxel or cabozantinib in subjects with angiosarcoma by determination of overall survival (OS) for each combination.
To determine clinical activity of the addition of nivolumab to cabozantinib in subjects with taxane pre-treated angiosarcoma by determination of progression free survival (PFS) at 6 months by RECIST v1.1 criteria.
To assess toxicity of the concurrent nivolumab-paclitaxel and nivolumab-cabozantinib combinations in subjects with angiosarcoma based on NCI-CTCAE v.5.0.
To measure symptomatic adverse events (AE) for patients via PRO-CTCAE.
Co-primary Objectives
To determine the progression free survival (PFS) for paclitaxel with and without nivolumab in subjects with taxane naïve angiosarcoma.
To determine the overall response rate (ORR) of nivolumab in combination with cabozantinib in patients with taxane pre-treated angiosarcoma.
Secondary objectives
to determine the ORR of paclitaxel in combination with nivolumab.
To determine clinical activity of the addition of nivolumab to paclitaxel or cabozantinib in subjects with angiosarcoma by determination of overall survival (OS) for each combination.
To determine clinical activity of the addition of nivolumab to cabozantinib in subjects with taxane pre-treated angiosarcoma by determination of progression free survival (PFS) at 6 months by RECIST v1.1 criteria.
To assess toxicity of the concurrent nivolumab-paclitaxel and nivolumab-cabozantinib combinations in subjects with angiosarcoma based on NCI-CTCAE v.5.0.
To measure symptomatic adverse events (AE) for patients via PRO-CTCAE.
Recruitment Status
Past Studies