TheraSphere With Durvalumab and Tremelimumab for HCC

NCT05063565 | Active Not Recruiting Phase 2 DMC FDA Drug FDA Device

• 1 other identifier: S2472
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 36

Brief Summary

The objective of the ROWAN clinical study is to assess the efficacy of local tumor control in HCC patients who receive TheraSphere followed by durvalumab and tremelimumab.

Conditions

Hepatocellular Carcinoma

Keywords

Carcinoma; Carcinoma, Hepatocellular; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Complete response and partial response evaluated by mRECIST.

  Start of Treatment (Day 1) up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated)

Secondary Outcomes (36)

• Number of immune mediated AEs and SAEs.

  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 treated).

• Number of patients whose durvalumab and/or tremelimumab treatment was temporarily halted, postponed or permanently discontinued due to an AE.

  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 treated).

• Change from baseline in liver function tests (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [GGT], alkaline phosphatase [ALK], bilirubin, albumin).

  Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

• Change from baseline in Child-Pugh score.

  Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

• Change from baseline in Albumin Bilirubin (ALBI) score.

  Baseline up to participant's death, opposition to data collection, lost to follow-up, or study termination (18 months after the last patient is treated).

Study Arms (1)

TheraSphere followed by Durvalumab and Tremelimumab

EXPERIMENTAL

TheraSphere followed by Tremelimumab plus Durvalumab administered once, then repeated administration of Durvalumab monthly up 18 months.

Device: TheraSphere Y-90 glass microsphere therapy; Drug: Durvalumab (Imfinzi) immunotherapy; Drug: Tremelimumab immunotherapy

Interventions

TheraSphere Y-90 glass microsphere therapy DEVICE

TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.

TheraSphere followed by Durvalumab and Tremelimumab

Durvalumab (Imfinzi) immunotherapy DRUG

1500 mg, every 4 weeks that continues for a maximum duration of 18 months or until confirmed progression (by site assessment), unacceptable toxicity, study withdrawal, or study early termination by the sponsor. Treatment beyond confirmed radiographic progression is permitted per patient consent if the following criteria are met: * Absence of clinical symptoms or signs indicating clinically significant disease progression * No decline in performance status * Absence of rapid disease progression or threat to vital organs or critical anatomical sites (i.e. new CNS metastasis, respiratory failure due to tumor compression, spinal cord compression) requiring urgent alternative medical intervention * No other treatment discontinuation criteria are met

TheraSphere followed by Durvalumab and Tremelimumab

Tremelimumab immunotherapy DRUG

300 mg, single administration

TheraSphere followed by Durvalumab and Tremelimumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be aged ≥18 years at the time of screening.
• Written informed consent and any locally required authorization (e.g., Health Insurance Portability and accountability Act in the US, European Union (EU) data privacy regulations in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Life expectancy ≥6 months.
• HCC, diagnosed by radiographic imaging or histology.
• Patient not a candidate for liver resection, thermal ablation, or transplantation at the time of study entry.
• ECOG 0 or 1
• Measurable disease by mRECIST criteria (e.g. ≥10mm of enhancement).
• Tumor volume ≤35% of whole liver volume (determined by imaging).
• Future liver remnant volume (FLRV) ≥30% of whole liver volume. FRLV is the volume of liver not planned to be treated with TheraSphere and free of HCC.
• Dosimetry criteria for tumor(s) and normal tissue can be determined.
• Patients with previous liver resection or ablation ≥6 months from end of previous treatment to TheraSphere administration.
• Previous transarterial chemoembolization (TACE) is permitted if:
• Previous TACE performed ≥8 months before TheraSphere administration and
• Result of previous TACE was CR and
• Current tumor is not a recurrence of previously treated lesion

You may not qualify if:

• Any contraindication to angiography or selective visceral catheterization.
• Cone Beam CT (CBCT) or Technetium-99m macroaggregated Albumin (99mTc-MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques.
• mTc-MAA hepatic arterial perfusion scintigraphy shows poor tumor and/or portal vein thrombosis (PVT) targeting that would lead to a dose that does not meet the liver dosing criteria.
• Shunting of blood to the lungs that could result in delivery of \>30 Gy to the lungs in a single treatment or \>50 Gy cumulative dose to the lungs in case of multiple TheraSphere treatments, as seen on 99mTc-MAA hepatic arterial perfusion scintigraphy.
• Vp3, Vp4, hepatic vein invasion, or inferior vena cava (IVC) invasion
• Extrahepatic metastases (patients with extrahepatic spread \[EHS\]):
• EHS is any extrahepatic lesion that, according to clinical symptoms, histology, or imaging data, is highly suspicious of being metastases.
• For patients with bone pain/neurological symptoms (deficit, seizure or else) at baseline and suspected of metastases at screening, a bone scan/brain MRI is recommended prior to study entry.
• Extrahepatic non-target non-measurable lesions (\<1 cm per RECIST 1.1) are acceptable if considered not suspicious by the investigator.
• Any previous systemic HCC treatment
• Prior exposure to immune mediated therapy for other disease, such as other anti-PD- 1, anti-PDL-1, anti-PDL-2, anti-CTLA-4, antibodies, etc.
• Previous liver radiation (external beam radiation therapy (EBRT) or peptide receptor radionuclide therapy (PRRT)).
• HCC with infiltrative disease that is not evaluable by mRECIST.
• Pulmonary insufficiency (defined by an arterial oxygen pressure (PaO2) of \<60 mmHg, or oxygen saturation (SaO2) of \<90% (Roussos \& Koutsoukou, 2003) or clinically evident chronic obstructive pulmonary disease (COPD)).
• Medical history of radiation pneumonitis or recent pneumonitis, regardless of causality

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Biocompatibles UK Ltd: collaborator

Study Sites (36)

University of Arizona- Banner Health

Tucson, Arizona, 85724, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Hospital

Chicago, Illinois, 60637, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University (Barnes-Jewish Hospital)

St Louis, Missouri, 63101, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Intermountain Health

Salt Lake City, Utah, 84157, United States

Location

CHU Nantes

Rennes, Cedex, 35042, France

Location

Hôpital Beaujon

Clichy, Hauts De Seine, 92110, France

Location

CHU Grenoble

Grenoble, Isere, 38043, France

Location

CHU de Bordeaux - Hôpital Haut-Lévêque

Clermont-Ferrand, France

Location

Chu Henri Mondor

Créteil, 94010, France

Location

Chru De Lille

Lille, 59037, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

CHU Angers - Hôpital Hôtel Dieu

Nantes, 49033, France

Location

CRLCC Eugene Marquis

Rennes, France

Location

Hopital Paul Brousse

Villejuif, 94800, France

Location

National Cancer Institute of Milan, Italy

Milan, 20133, Italy

Location

IRCCS - Regina Elena Cancer Institute

Roma, Italy

Location

Azienda Sanitaria Universitaria Integrata Friuli Centrale (ASU FC)

Udine, Italy

Location

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital Gregorio Maranon

Madrid, Spain

Location

Hospital Universitario Virgen de las Nieves

Madrid, Spain

Location

Hospital. Ramon Y Cajal

Madrid, Spain

Location

Hospital Universitari

Valencia, 46026, Spain

Location

Clinico de Valladolid

Valladolid, 47012, Spain

Location

University Hospital of Bern

Bern, 3010, Switzerland

Location

University Hospital Geneva (HUG)

Geneva, 1211, Switzerland

Location

Related Links

• Boston Scientific Website ROWAN Clinical Trial Overview

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Interventions

durvalumab; Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Beau Toskich, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Aiwu Ruth He, MD PhD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: October 1, 2021
• Study Start: November 3, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); FR (10); ES (8); US (13); CH (2)