AzTrials
AzTrials

Hepatocellular Carcinoma Non-resectablePhase 2IMMUWINNCT04522544

Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC

A Phase 2 study testing Tremelimumab, Durvalumab and Y-90 SIRT in people with Hepatocellular Carcinoma Non-resectable and HCC, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 11 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma Non-resectable, HCC
What is being tested?
Tremelimumab, Durvalumab and Y-90 SIRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
11 sitesGermany
Study dates
15 Dec 2020to 31 Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 25Show fewer
  • 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;
  • International normalized ratio (INR) ≤ 1.25.
  • Albumin ≥ 31 g/dL.
  • Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine clearance CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
  • Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial and must use two effective forms of contraception if sexually active.
  • Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving IMP and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational products (Durvalumab and Tremelimumab). Women who are not of childbearing potential (i.e. who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception).
  • If patient has concurrent Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection, meets the following criteria:
  • Patients with HBV or HCV infection should be monitored for viral levels during study participation;
  • Patients with detectable hepatitis B surface antigen (HBsAg) or detectable HBV DNA should have HBV DNA < 100 IU/ml and should be managed per local treatment guidelines. Controlled (treated) hepatitis B subjects will be allowed if they started treatment at the time point of enrollment into the study by the latest and treatment is continued during study participation and for ≥ 6 months after end of study treatment;
  • HCV patients with advanced HCC are mostly not treated for their HCV infection. However, patients treated for HCV are considered suitable for inclusion if antiviral therapy has been completed prior to first administration of study drug.
  • Subject is willing and able to comply with the protocol for the duration of the study including

Who cannot join

  • 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;
Show all 44Show fewer
  • 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);
  • Cardiac arrhythmias (Grade > 2 NCI-CTCAE Version 5.0) which are poorly controlled with anti-arrhythmic therapy or requiring pace maker;
  • Uncontrolled hypertension;
  • Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug.
  • Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
  • Prior, systemic anti-cancer therapy, radiotherapy administered < 4 weeks prior to study entry, endocrine- or immunotherapy or use of other investigational agents.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of Durvalumab or Tremelimumab. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
  • Systemic corticosteroids at physiologic doses not to exceed <<10 mg/day>> of prednisone or its equivalent
  • Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  • Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
  • Major surgery within 4 weeks of starting the study and patients must have recovered from effects of major surgery.
  • Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix, unless curatively treated and disease-free for 3 years or longer.
  • Any co-existing medical condition that in the investigator's judgement will substantially increase the risk associated with the patient's participation in the study.
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
  • History of allogenic organ transplantation.
  • Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or compliance with the study protocol.
  • Symptomatic brain metastases. A scan to confirm the absence of brain metastases is required in the presence of corresponding symptoms.
  • Pregnant or breast-feeding women.
  • Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Patients without active disease in the last 5 years may be included but only after consultation with the study physician
  • Patients with celiac disease controlled by diet alone
  • Known allergy or hypersensitivity to any of the IMPs or any of the constituents of the product.
  • Is currently participating or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
  • Patient who has been incarcerated or involuntarily

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Germany11 sites

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Köln

    Cologne, 50937

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Jena

    Jena, 07747

  • Universtitätsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • München Klinik Bogenhausen

    München, 81925

  • Universitätsklinikum Münster

    Münster, 48149

  • Universitätsklinikum Tübingen

    Tübingen, 72076

Other trials in Germany

About this study

Official title: A Phase II Study of Immunotherapy With Durvalumab (MEDI4736) and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC

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

Read the detailed description

The IMMUWIN phase II will test the safety and anti-tumor efficacy of the combination of Durvalumab and Tremelimumab with Y-90 SIRT.

Being tested
Tremelimumab, Durvalumab, Y-90 SIRT, DEB-TACE
Keywords
hepatocellular carcinoma, intermediate stage HCC, SIRT, Durvalumab, Tremelimumab, TACE
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TremelimumabDrug

    300 mg Tremelimumab C1D1

  • DurvalumabDrug

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

  • Y-90 SIRTProcedure or surgery

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

  • DEB-TACEProcedure or surgery

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

Study groups in NCT04522544
Study groupRoleWhat they receive
SIRT (Arm A)ExperimentalY-90 SIRT + Tremelimumab + Durvalumab
Receives: Drug: Tremelimumab; Drug: Durvalumab; Procedure: Y-90 SIRT
TACE (Arm B)ExperimentalDEB-TACE + Tremelimumab + Durvalumab
Receives: Drug: Tremelimumab; Drug: Durvalumab; Procedure: DEB-TACE

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (6)

  1. Progression free survival (PFS)

    Time from the date of randomization to the date of first observed disease progression (investigator assessment according to RECIST 1.1) or death from any cause.

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

  2. Overall survival (OS)

    Overall survival will be determined as time from the date of treatment allocation to the date of death.

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

  3. Treatment related SAEs

    Treatment related serious adverse events rate (SAE) will be determined. All observed toxicities and side effects will be graded according to NCI CTCAE v5.0 for all patients and the degree of association of each with the study treatment assessed and summarized.

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

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

    ORR as BOR during therapy will be defined as the proportion of allocated subjects with best response of complete or partial response from date of randomization until disease progression or death from any cause occurs.

    Measured: 13 months

  5. Overall response rate (ORR) at 6 months

    ORR at 6 months for patients who received single treatment of TACE/SIRT

    Measured: 6 months

  6. Quality of Life (QoL)

    Quality of life will be assessed by the European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30 questionnaire) and will be evaluated based on the EORTC QLQ-C30 scoring manual in its most current version at time of data analysis.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start15 Dec 2020
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04522544
Sponsor's protocol ID
IMMUWIN
Other IDs
ESR-19-14400, 2024-513950-32-00, 2019-004597-26, AIO-HEP-0319/ass, IKF027, 2019
Acronym
IMMUWIN
Status last verified
Jun 2026
First submitted
4 Aug 2020
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tremelimumab, Durvalumab and Y-90 SIRT in people with Hepatocellular Carcinoma Non-resectable and HCC, run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 11 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) [according to RECIST 1.1] at 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04522544.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in