COVID-19 Safety Precautions: Find the Latest Visitor and Mask Policies. Learn More
Clinical Trials Search
A Multicenter Phase II Trial of Paclitaxel with and without Nivolumab in Taxane Naïve, and Nivolumab and Cabozantinib in Taxane Pre-treated Subjects with Angiosarcoma
This phase II trial studies how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma that have not received taxane drugs, and how well nivolumab and cabozantinib work in treating taxane pretreated patients with soft tissue sarcoma. Nivolumab works through the body's immune system to help the immune system act against tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial is being done to see if the combination of nivolumab and paclitaxel or cabozantinib can shrink soft tissue sarcoma and possibly prevent it from coming back.
OBJECTIVES 2.1 Co-primary Objectives 2.1.1 To determine the progression free survival (PFS) for paclitaxel with and without nivolumab in subjects with taxane naïve angiosarcoma. 2.1.2 To determine the overall response rate (ORR) of nivolumab in combination with cabozantinib in patients with taxane pre-treated angiosarcoma. 2.2 Secondary objectives 2.2.1 To determine the ORR of paclitaxel in combination with nivolumab. 2.2.2 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. 2.2.3 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. 2.2.4 To assess toxicity of the concurrent nivolumab-paclitaxel and nivolumab-cabozantinib combinations in subjects with angiosarcoma based on NCI-CTCAE v.5.0. 2.2.5 To measure symptomatic adverse events (AE) for patients via PRO-CTCAE.
BMS-936558 (Nivolumab); Cabozantinib (XL 184); Nivolumab (Opdivo); Taxol (paclitaxel); paclitaxel ()