E-Newsletter - October 2020
Spotlight on Alliance Trials
 

Alliance Trial Focuses on How to Shrink ANGIOSarcoma with Combination Therapies

Alliance A091902: A multicenter phase II trial of paclitaxel with and without nivolumab in taxane naive, and nivolumab and cabozantinib in taxane pretreated subjects with angiosarcoma

Juneko Grilley-Olson, MD, of University of North Carolina at Chapel Hill, is leading Alliance A091902, a trial that studies how well paclitaxel with and without nivolumab works in treating patients with soft tissue sarcoma who have not received taxane drugs (those that block cell growth by stopping cell division), and how well nivolumab and cabozantinib work in treating taxane pretreated patients with angiosarcoma, a specific type of 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 angiosarcoma and possibly prevent it from coming back. Although immune-based therapies have only had modest success in soft tissue sarcomas in general, angiosarcomas may have improved responsiveness to immune-based approaches.

The trial’s co-primary objectives are to determine the progression-free survival for paclitaxel with and without nivolumab in patients with taxane-naïve angiosarcoma and to determine the overall response rate of nivolumab in combination with cabozantinib in patients with taxane pre-treated angiosarcoma.

Patients who have never received taxane-type chemotherapy before will be randomized to one of two groups to receive either combination chemotherapy with paclitaxel and nivolumab or chemotherapy with paclitaxel alone. Patients will receive either of these treatments until cancer progression or unacceptable side effects. Patients who receive paclitaxel alone will have the opportunity to receive cabozantinib and nivolumab after the paclitaxel chemotherapy. Patients who have received taxane-type chemotherapy before will receive a combination of chemotherapy with cabozantinib and nivolumab, until cancer progression or unacceptable side effects. Paclitaxel and nivolumab chemotherapy will be administered intravenously. Paclitaxel will be given once per week for three weeks followed by a one-week break. Nivolumab will be given once every four weeks. Cabozantinib will be taken orally once per day. Patients taking cabozantinib will be required to keep a medication diary. All patients will be followed every three months for three years after treatment.

For complete information on the trial design, treatment plan, and patient eligibility, refer to the study protocol, which can be found on the Alliance website or the CTSU website.  

Study Chair: Juneko Grilley-Olson, MD, University of North Carolina at Chapel Hill | E-mail: juneko_grilley-olson@med.unc.edu
Activated: 9/04/2020  | Status: Now recruiting participants
CT.gov Link: http://bit.ly/Alliance-A091902

 

For other articles in this issue of Alliance E-News, see below.