ROWAN study overview
ROWAN will explore if there is a benefit of TheraSphere Y-90 Glass Microspheres with immunotherapy to improve response for HCC patients.
HCC
100 patients
Global study
Up to 50 sites
Summary
The ROWAN study is a global, open-label, multi-center, phase II, single-arm study to assess the efficacy of TheraSphere Y-90 Glass Microspheres followed by Durvalumab (Imfinzi®) with Tremelimumab (Imjudo®) (STRIDE regimen) in patients with hepatocellular carcinoma.
Caution: New Drug - Limited by Federal (or United States) law to investigational use.
Patient Criteria
Patients ≥ 18 years old of age with HCC who are not eligible for, or who have declined treatment with resection, ablation or liver transplant, will be considered for participation in this trial.
Treatment
Patients will receive TheraSphere Y-90 treatment followed by a single dose of Tremelimumab in combination with Durvalumab which is given every 4 weeks to maximum of 18 months.
Primary outcome measures
Assessment of the efficacy of TheraSphere followed by Durvalumab with Tremelimumab in HCC patients.
Objective response rate (ORR)
Complete response and partial response evaluated by mRECIST.
Secondary outcome measures
- To explore whether systemic treatment with Durvalumab and Tremelimumab after TheraSphere can enhance other efficacy endpoints.
- To assess the safety and toxicity of TheraSphere followed by Durvalumab and Tremelimumab.
- To determine tumor and normal tissue absorbed radiation dose and its relationship with response, outcomes, and liver volume changes after treatment.
- To determine if there is a difference in quality of life before and after treatment using the FACT-Hep and EQ-5D questionnaires.
Referring physician information
If you have questions about the ROWAN study and patient eligibility, please contact one of the principal investigators below.
Mayo Clinic
City: Jacksonville, FL
Principal Investigator: Beau Toskich, MD
Medstar Georgetown University Hospital, Lombardi Comprehensive Cancer Center
City: Washington, DC
Principal Investigator: Aiwu Ruth He, MD, PhD
Clinical trial managers
For more information about the ROWAN study, please contact the clinical trial manager.
Patrice Feaster at patrice.feaster@bsci.com
TheraSphere is a registered trademark of Theragenics Corporation used under license by Biocompatibles UK Ltd., a wholly owned subsidiary of Boston Scientific Corporation.