Safety and Efficacy Study of Radioembolization in Combination With Durvalumab in Locally Advanced and Unresectable HCC (SOLID)

March 14, 2023 updated by: Yoon Jun Kim, Seoul National University Hospital

A Single-arm, Open-label, Safety and Efficacy Study of Radioembolization With Yttrium-90 Microspheres in Combination With Durvalumab (MEDI4736) in Locally Advanced and Unresectable Hepatocellular Carcinoma (HCC) (SOLID)

Safety and Efficacy Study of Radioembolization with Yttrium-90 Microspheres in Combination with Durvalumab in Locally Advanced Hepatocellular Carcinoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a single arm, open-label study to evaluate safety and efficacy of Radioembolization with Yttrium-90 Microspheres in Combination with Durvalumab in Locally Advanced and Unresectable Hepatocellular Carcinoma which to be implemented at a single site in Korea.

Transarterial radioembolization (TARE) with yttrium-90 microspheres will be employed in combination with an intravenous (IV) durvalumab until PD. TARE will be performed before the first dose of durvalumab. Exploratory biomarker testing will be done on tumor tissues prior to treatment and plasma samples prior to treatment and at the time of PD.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with unequivocal HCC confirmed histologically or diagnosed radiologically
  • Locally advanced HCC
  • Must have at least 1 untreated measurable disease
  • Child-Pugh score ≤7 points
  • Adequate normal organ and marrow function.

Exclusion Criteria:

  • Eligible for potentially curative treatment (surgical resection, radio-frequency ablation or immediate liver transplantation)
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody
  • Any other concurrent malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, papillary thyroid cancer, early gastric cancer, or other cancer for which the patient has been disease-free for at least five years.
  • Evidence of extrahepatic metastasi(e)s, except for regional lymph node(s) involvement
  • History of leptomeningeal carcinomatosis , History of active primary immunodeficiency
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.

Exclusion Criteria Specific to Radioembolization:

•The screening angiogram and technetium-99m macroaggregated albumin (99mTc-MAA) scan are used to determine lobar liver volume from CT or MR images, to identify vascular shunting to the GI tract requiring use of angiographic occlusion techniques and to determine the lung shunt fraction.

Patients who are ineligible to radioembolization meeting the following criteria will not be included in the study. Additional patients will be screened to replace those patients.

  • Deposition of yttrium-90 microspheres to the GI tract that cannot be corrected by placement of the catheter distal to collateral vessels or the application of standard angiographic techniques, such as coil embolization to prevent deposition of yttrium-90 microspheres in the GI tract.
  • Exposure of radiation to the lungs exceeds 30 Gray (Gy) for a single infusion or 50 Gy cumulative for all infusions of yttrium-90 microspheres.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yttrium-90 Microspheres in Combination with Durvalumab
Transarterial radioembolization (TARE) with yttrium-90 microspheres will be employed in combination with an intravenous (IV) dose of 1500 mg durvalumab every 4 weeks (Q4W) until PD. TARE will be performed 1-2 weeks (7 to 14 days) before the first dose of durvalumab and a maximum of 2 more times during the treatment period, per Investigator discretion. If additional TARE is performed, the interval between additional TARE treatments and administration of durvalumab should be at least 1 week.
Drug: Durvalumab
Radioembolization with Yttrium-90 Microspheres
Other Names:
  • Imfinzi®
Radiation: Radioembolization
Radioembolization with Yttrium-90 Microspheres
Other Names:
  • TheraSphere™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTP
Time Frame: From date of enrollment until the date of first documented progression, assessed up to 12 months
to evaluate time to progression (TTP) from enrolment using Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
From date of enrollment until the date of first documented progression, assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: From date of enrollment until the date of first documented progression, assessed up to 12 months
Overall Survival (OS) from first dose of study drug until the time of data cut-off, as determined by the Investigator.
From date of enrollment until the date of first documented progression, assessed up to 12 months
ORR
Time Frame: From date of enrollment until the date of first documented progression, assessed every 8 weeks up to 12 months.
Objective Response Rate (ORR) of Target Lesion(s) and Non-Target Lesion(s)
From date of enrollment until the date of first documented progression, assessed every 8 weeks up to 12 months.
Number of participants with treatment-related adverse events
Time Frame: Until 30 days after radioembolization with yttrium-90 microspheres or the last dose of durvalumab
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Until 30 days after radioembolization with yttrium-90 microspheres or the last dose of durvalumab

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Yoon Jun Kim, MD. PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2020

Primary Completion (Actual)

July 6, 2022

Study Completion (Actual)

July 28, 2022

Study Registration Dates

First Submitted

August 20, 2019

First Submitted That Met QC Criteria

October 10, 2019

First Posted (Actual)

October 14, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOLID (Other Identifier: Princess Margaret Cancer Centre)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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