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
Contact: Qandeel Anwar
Email: Anwar.Qandeel@mayo.edu
Georgetown University
City: Washington, DC
Principal Investigator: Aiwu Ruth He, MD, PhD
Contact: David Odhiambo Seeh, MS, B.Sc, HND
Email: dos9@georgetown.edu
Medstar Georgetown University Hospital, Lombardi Comprehensive Cancer Center
City: Washington, DC
Principal Investigator: Aiwu Ruth He, MD, PhD
Contact: Shelley Collins
Washington University (Barnes-Jewish Hospital)
City: St. Louis, MO
Principal Investigator: J. Daniel Giardina, MD
Contact: Tami Perkins, RN
Email: ptamara@wustl.edu
Rush University Medical Center
City: Chicago, IL
Principal Investigator: Audrey Kam, MD
Contact: Jesse Molina
Email: cancer_studies@rush.edu
NYU Langone Health
City: New York, NY
Principal Investigator: Nina Beri, MD
Contact: Dunbar Sharpe
Email: dunbar.sharpe@nyulangone.org
Clinicia Universitaria de Navarra
City: Pamplona, Navarre, Spain
Principal Investigator: Bruno Sangro, MD
Contact: Andoni Salvatierra
Email: asalvatierrai@unav.es
Hospital Universitario Ramon y Cajal
City: Madrid, Spain
Principal Investigator: José Luis Lledó, MD
Contact: Carolina Garcia, José Luis Lledó, MD, Antonio Guerrero, MD
Email: carogarcia.irycis@gmail.com, jllledo63@yahoo.es, antonio.guerrero90@hotmail.com
University of Minnesota
City: Minneapolis, MN
Principal Investigator: Siobhan Flanagan, MD
Contact: Connie Dale
Email: dalex179@umn.edu
Indiana University Medical Center
City: Indianapolis, IN
Principal Investigator: Paul Haste, MD
Contact: Eric Grubbs
Email: eegrubbs@iu.edu
University of Chicago Hospital
City: Chicago, IL
Principal Investigator: Anjana Pillai, MD
Contact: Aurelie Desgardin
Email: adesgard@bsd.uchicago.edu
Ochsner Clinic Foundation
City: New Orleans, LA
Principal Investigator: Lingling Du, MD
Contact: Jessica Denaud, Nicole Perry
Hosp. Universitario Central de Asturias
CRLCC Eugene Marquis
City: Rennes, France
Principal Investigator: Julien Edeline, MD
Contact: Clarisse Rechede
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 Boston Scientific Medical Device Limited, a wholly owned indirect subsidiary of Boston Scientific Corporation.