ROWAN study overview
ROWAN will explore if there is a synergistic benefit of TheraSphere Y-90 Glass Microspheres with immunotherapy to improve response to cancer therapy in early and intermediate stage HCC patients.
TheraSphere clinical program enrolling more than 2,000 patients worldwide.
TheraSphere clinical series HCC
*CAUTION: In the U.S. TheraSphere is under an investigational device exemption for treatment of patients with metastatic colorectal cancer. The safety and effectiveness for this treatment has not been established.
Objectives
To assess the durability of local tumor control in HCC patients who receive TheraSphere followed by Durvalumab and Tremelimumab, compared to those who receive TheraSphere treatment alone.
Primary endpoints
Objective Response Rate (ORR) [ Time Frame: Treatment (Day 1) up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is randomized) ] Complete response and partial response evaluated by localized modified Response evaluation Criteria in Solid Tumors (mRECIST).
Duration of response (DoR) [ Time Frame: Time of response up to progression, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is randomized) ] According to localized mRECIST.
Design & enrollment
- Design – A global, open-label, prospective, multi-center, randomized, Phase II trial with two treatment arms designed to assess the safety and efficacy of TheraSphere administered before initiation of Durvalumab with Tremelimumab in HCC patients not eligible for or who have declined treatment with resection and/or ablation or liver transplant.
- Enrollment – 150 patients, ~20 sites in the US and EU.
TheraSphere is a registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd., a wholly owned subsidiary of Boston Scientific Corporation.