NCT04522544

Brief Summary

A Phase II study of immunotherapy with Durvalumab (MEDI4736) and Tremelimumab in combination with Y-90 SIRT for intermediate stage HCC

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
20mo left

Started Dec 2020

Longer than P75 for phase_2

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Dec 2020Dec 2027

First Submitted

Initial submission to the registry

August 4, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

6.6 years

First QC Date

August 4, 2020

Last Update Submit

February 17, 2026

Conditions

HCCHepatocellular Carcinoma Non-resectable

Keywords

hepatocellular carcinomaintermediate stage HCCSIRTDurvalumabTremelimumabTACE

Outcome Measures

Primary Outcomes (1)

  • Objective response rate (ORR) [according to RECIST 1.1] at 6 months.

    Proportion of allocated subjects with best response of complete or partial response

    6 months

Secondary Outcomes (6)

  • Progression free survival (PFS)

    Time from the date of randomization to the date of first observed disease progression or death (approx. 42 months)

  • Overall survival (OS)

    From the date of treatment Date of enrollment until date of death if applicable (up to 42 months until Study Closure)

  • Treatment related SAEs

    From first patient included until study closure (approx. 42 months after First Patient Included)

  • Overall response rate (ORR) as best overall response (BOR) during therapy

    13 months

  • Overall response rate (ORR) at 6 months

    6 months

  • +1 more secondary outcomes

Other Outcomes (1)

  • Translational research

    3 months

Study Arms (2)

SIRT (Arm A)

EXPERIMENTAL

Y-90 SIRT + Tremelimumab + Durvalumab

Drug: TremelimumabDrug: DurvalumabProcedure: Y-90 SIRT

TACE (Arm B)

EXPERIMENTAL

DEB-TACE + Tremelimumab + Durvalumab

Drug: TremelimumabDrug: DurvalumabProcedure: DEB-TACE

Interventions

DurvalumabDRUG

1500 mg Durvalumab C1D1 + Q4W (max. 13 cycles)

SIRT (Arm A)TACE (Arm B)
Y-90 SIRTPROCEDURE

Locoregional therapy will be performed as a standard-of-care procedure

SIRT (Arm A)
DEB-TACEPROCEDURE

Locoregional therapy will be performed as a standard-of-care procedure

TACE (Arm B)
TremelimumabDRUG

300 mg Tremelimumab C1D1

SIRT (Arm A)TACE (Arm B)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capable of giving written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
  • Age ≥ 18 years at time of study entry.
  • Body weight \> 30 kg.
  • Multinodular or large, solitary HCC, not eligible for resection or local ablation.
  • Histologically confirmed diagnosis of HCC.
  • Scheduled to receive locoregional therapy as standard of care.
  • At least one measurable site of disease as defined by RECIST 1.1criteria with spiral CT scan or MRI.
  • No prior systemic anti-cancer therapy.
  • Child-Pugh A.
  • Performance status (PS) ≤ 1 (ECOG scale).
  • Life expectancy of at least 12 weeks.
  • Adequate blood count, liver-enzymes, and renal function:
  • Hemoglobin ≥ 9.0 g/dL, absolute neutrophil count ANC ≥1.5 (or 1.0) x (\> 1500 per mm\^3), platelets ≥100 (or 75) x 10\^9/L (\>75,000 per mm\^3);
  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN);
  • AST (SGOT), ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤5x ULN;
  • +9 more criteria

You may not qualify if:

  • Diffuse HCC or presence of vascular invasion or extrahepatic spread with the following exception:
  • o Invasion of a segmental portal vein or hepatic veins.
  • Patients with advanced liver disease as defined below:
  • o liver cirrhosis with stage Child Pugh B and C.
  • Any contraindications for hepatic embolization procedures:
  • Known hepatofugal blood flow;
  • Known porto-systemic shunt;
  • Impaired clotting test (platelet count \< 70 x 10\^9/L, INR \> 1.25);
  • Renal failure/insufficiency requiring hemo-or peritoneal dialysis;
  • Known severe atheromatosis;
  • Total thrombosis or total invasion of the main branch of the portal vein.
  • Locoregional therapies ongoing or completed \< 4 weeks prior to the baseline scan.
  • History of cardiac disease:
  • Congestive heart failure \> New York Heart Association (NYHA) class 2;
  • Active coronary artery disease (CAD) (myocardial infarction ≥ 6 months prior to study entry is allowed);
  • +29 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Universitätsklinikum Bonn

Bonn, 53127, Germany

RECRUITING

Universitätsklinikum Köln

Cologne, 50937, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

WITHDRAWN

Universitätsmedizin Göttingen

Göttingen, 37075, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitätsklinikum Jena

Jena, 07747, Germany

RECRUITING

Universtitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

RECRUITING

Klinikum rechts der Isar der Technischen Universität München

München, 81675, Germany

RECRUITING

München Klinik Bogenhausen

München, 81925, Germany

RECRUITING

Universitätsklinikum Münster

Münster, 48149, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

tremelimumabdurvalumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Salah-Eddin Al-Batran, Prof. Dr.

    Frankfurter Institut für Klinische Krebsforschung IKF GmbH

    STUDY DIRECTOR

  • Arndt Vogel, Prof. Dr.

    Hannover Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arndt Vogel, Prof. Dr.

CONTACT

+49 511 532 9590vogel.arndt@mh-hannover.de

Johanna Riedel, Dr.

CONTACT

+49 69 7601 4635riedel.johanna@ikf-khnw.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 21, 2020

Study Start

December 15, 2020

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

No IPD will be shared.

Locations

DE(12)