search
Back to results

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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Durvalumab
Radioembolization
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring HCC, Durvalumab

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yttrium-90 Microspheres in Combination with Durvalumab

Arm Description

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.

Outcomes

Primary Outcome Measures

TTP
to evaluate time to progression (TTP) from enrolment using Modified Response Evaluation Criteria in Solid Tumors (mRECIST).

Secondary Outcome Measures

OS
Overall Survival (OS) from first dose of study drug until the time of data cut-off, as determined by the Investigator.
ORR
Objective Response Rate (ORR) of Target Lesion(s) and Non-Target Lesion(s)
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Full Information

First Posted
August 20, 2019
Last Updated
March 14, 2023
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04124991
Brief Title
Safety and Efficacy Study of Radioembolization in Combination With Durvalumab in Locally Advanced and Unresectable HCC
Acronym
SOLID
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
HCC, Durvalumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yttrium-90 Microspheres in Combination with Durvalumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Durvalumab
Other Intervention Name(s)
Imfinzi®
Intervention Description
Radioembolization with Yttrium-90 Microspheres
Intervention Type
Radiation
Intervention Name(s)
Radioembolization
Other Intervention Name(s)
TheraSphere™
Intervention Description
Radioembolization with Yttrium-90 Microspheres
Primary Outcome Measure Information:
Title
TTP
Description
to evaluate time to progression (TTP) from enrolment using Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
Time Frame
From date of enrollment until the date of first documented progression, assessed up to 12 months
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival (OS) from first dose of study drug until the time of data cut-off, as determined by the Investigator.
Time Frame
From date of enrollment until the date of first documented progression, assessed up to 12 months
Title
ORR
Description
Objective Response Rate (ORR) of Target Lesion(s) and Non-Target Lesion(s)
Time Frame
From date of enrollment until the date of first documented progression, assessed every 8 weeks up to 12 months.
Title
Number of participants with treatment-related adverse events
Description
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame
Until 30 days after radioembolization with yttrium-90 microspheres or the last dose of durvalumab

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon Jun Kim, MD. PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs