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Hepatocellular Carcinoma (HCC)Phase 1/2NCT06911255

Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma

A Phase 1/2 study testing Tremelimumab Plus Durvalumab (MEDI4736) and Transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Carcinoma, run by Yoon Jun Kim at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Tremelimumab Plus Durvalumab (MEDI4736) and Transarterial chemoembolization (TACE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSouth Korea
Study dates
18 Apr 2025to 30 Jun 2028
Phase
Phase 1/2
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
  • 2. Male or female, aged ≥19 years at time of study entry. 3. Diagnosed with unequivocal HCC confirmed histologically or diagnosed radiologically according to American Association for the Study of Liver Diseases practice guideline.
  • 4. Barcelona clinic liver cancer (BCLC) staging intermediate (B) stage or BCLC advanced stage (C) HCC with or without minimal extrahepatic disease (single-organ metastasis, ≤5 metastatic lesions).
  • 5. Must have at least 1 untreated measurable disease (untreated target lesion i.e. a viable lesion that has never been treated with locoregional treatment [transarterial chemoembolization {TACE}, TARE, percutaneous ethanol injection therapy, or radiofrequency ablation]).
  • 6. Child-Pugh score 5 or 6 points (Child-Pugh class A). 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 8. Life expectancy of ≥ 12 weeks. 9. Body weight >30 kg. 10. Adequate normal organ and marrow function as defined below:
  • Hemoglobin ≥9.0 g/dL
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  • Absolute neutrophil count (ANC) ≥1500 per mm3
  • Platelet count ≥75,000 per mm3
  • Albumin ≥2.8 g/dL
  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with the Investigator).
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤5 x institutional ULN
  • 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:
  • Males:
  • Creatinine CL (mL/min) Females:
  • Creatinine CL (mL/min)
  • Weight (kg) x (140 - Age) 72 x serum creatinine (mg/dL)
  • Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL) 11. Female patients must be either postmenopausal or, if premenopausal, must have a negative pregnancy test and agree to use 2 forms of contraception, if sexually active during their study participation.
  • Male patients must be surgically sterile or, if sexually active and having a pre-menopausal female partner then, must be using an acceptable form of contraception.
  • Adequate contraception allowed in this trial is as follows:
  • Hormonal contraceptives such as combined oral contraceptive pill
  • Intrauterine devices or the implantation of intrauterine system (IUS)
  • Blockage methods (spermicides and condoms/spermicides and vaginal diaphragm for contraception, vaginal sponges or cervical cap) • Blockage methods (spermicides and condoms/spermicides and vaginal diaphragm for contraception, vaginal sponges or cervical cap)
  • Sterilization surgery such as tubal ligation in females and vasectomy in males. 12. Evidence of postmenopausal status or negative urinary or serum pregnancy test for female premenopausal patients. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Women ≥50 years of age would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • 13. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • 1. Eligible for potentially curative treatment (surgical resection, radiofrequency ablation or immediate liver transplantation).
  • 2. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti- Cytotoxic T-lymphocyte- associated antigen-4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune pathways, including prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment.
  • 3. History of organ transplantation or hematopoietic stem cell transplantation.
  • 4. 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.
  • 5. A history of a severe contrast allergy (i.e. anaphylaxis) not controlled with premedication.
  • 6. Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product (IP) or interpretation of patient safety or study results.
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  • 7. Participation in another clinical study with an IP during the last 8 weeks or 5 half-lives of the study drug, whichever is longer, prior to screening.
  • 8. Concurrent enrolment in another clinical study, unless it is an observational (non- interventional) clinical study or during the follow-up period of an interventional study.
  • 9. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) ≤1 cycle length or 14 days, whichever is longer, prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period will be required, as determined by the Investigator.
  • 10. Any unresolved toxicity NCI-CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
  • Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
  • Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and/or tremelimumab may be included at the discretion of the Investigator.
  • 11. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
  • 12. Prior hepatic radiation therapy including Total Body Irradiation (TBI) for HCC or other malignancy.
  • 13. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • 14. 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 15. 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 adverse events (AEs) or compromise the ability of the patient to give written informed consent.
  • 16. History of leptomeningeal carcinomatosis. 17. History of active primary immunodeficiency, including known positive tests for human immunodeficiency virus (HIV 1/2 antibodies).
  • 18. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), other than chronic infection of HBV or HCV. Participants with chronic HBV infection (positive hepatitis B surface antigen [HBsAg] and/or detectable HBV DNA) are eligible if they are receiving nucleos(t)ide analog treatment, as determined by the physician's judgment and in accordance with local practice guidelines. Those with a past or resolved HBV infection (defined as the presence of anti-hepatitis B core antibody and absence of HBsAg) are also eligible. For chronic HCV infection, participants positive for HCV antibody are eligible only if polymerase chain reaction for HCV RNA is negative.
  • 19. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab and/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., Computed tomography [CT] scan premedication) 20. 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.
  • 21. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth from screening to 90 days after the last dose of durvalumab and/or tremelimumab, or 180 days after the last TACE.
  • 22. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • 23. Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yoon Jun Kim, MD, PhD contact

82-2-2072-3081

yoonjun@snu.ac.kr

Yun Bin Lee, MD, PhD contact

82-2-2072-2228

yblee@snu.ac.kr

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Yoon Jun Kim, MD, PhD, 82-2-2072-3081, yoonjun@snu.ac.kr

    Yun Bin Lee, MD, PhD, 82-2-2072-2228, yblee@snu.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase I/IIa, Single-arm, Open-label, IIT for Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination With Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma

Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma

Read the detailed description

The purpose of this clinical trial is to evaluate the safety and efficacy of tremelimumab + durvalumab administered concurrently with transarterial chemoembolization (TACE) in patients diagnosed with hepatocellular carcinoma (HCC) who are not eligible for curative liver resection.

Primary Objective:

The primary objective of this clinical trial is to evaluate progression-free survival (PFS) from the time of registration using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Secondary Objectives:

Overall Survival (OS):

To assess the overall survival from the first dose of the study drug until the data cutoff point, as determined by the investigator.

Objective Response Rate (ORR):

To assess the objective response rate of target and non-target lesions using mRECIST and RECIST 1.1. Evaluations will occur every 8 weeks after 12 weeks and for the first 48 weeks from the time of registration, and then every 12 weeks thereafter.

Time to Progression (TTP):

To measure the time from registration to disease progression using mRECIST and RECIST 1.1.

Safety Evaluation:

To evaluate the safety of tremelimumab and durvalumab, including adverse events, vital signs (blood pressure and pulse rate), and laboratory safety assessments (clinical chemistry, hematology, etc.), by assessing changes from baseline.

Being tested
Tremelimumab Plus Durvalumab (MEDI4736), Transarterial chemoembolization (TACE)
Keywords
HCC Durvalumab
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Tremelimumab Plus Durvalumab (MEDI4736)Drug

    Also called Imfinzi®, Imjudo

    Study subjects will receive 1,500 mg of durvalumab intravenously every 4 weeks until PD is observed. However, treatment will be discontinued if unacceptable toxicity, withdrawal of consent, or any other discontinuation criteria are met. Tremelimumab will be administered first, and durvalumab infusion will begin approximately 1 hour (up to 2 hours) after the completion of tremelimumab infusion. The standard infusion time for each drug is 1 hour, but if the infusion is temporarily interrupted, the total duration should not exceed 8 hours at room temperature.

  • Transarterial chemoembolization (TACE)Procedure or surgery

    TACE will be carried out 1 to 2 weeks (7 to 14 days) after the administration of tremelimumab + durvalumab, and thereafter, it will be performed as needed at the discretion of the investigator during the treatment period. If additional TACE is performed, there must be at least a 1-week interval between the additional TACE and the administration of durvalumab.

Study groups in NCT06911255
Study groupRoleWhat they receive
Tremelimumab Plus Durvalumab (MEDI4736) in Combination with Concurrent Transarterial ChemoembolizatiExperimentalAfter the intravenous (IV) administration of 300 mg of tremelimumab and 1,500 mg of durvalumab, transarterial chemoembolization (TACE) will be performed in combination with 1,500 mg of durvalumab via IV infusion every 4 weeks (Q4W) until disease progression (PD) is confirmed. TACE will be carried out 1 to 2 weeks (7 to 14 days) after the administration of tremelimumab + durvalumab, and thereafter, it will be performed as needed at the discretion of the investigator during the treatment period. If additional TACE is performed, there must be at least a 1-week interval between the additional TACE and the administration of durvalumab.
Receives: Drug: Tremelimumab Plus Durvalumab (MEDI4736); Procedure: Transarterial chemoembolization (TACE)

What is being measured

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

  1. PFS

    The primary endpoint for evaluating progression-free survival (PFS) will be assessed through RECIST 1.1 evaluation.

    Measured: the time from the first study treatment administration until the date of objective disease progression

Secondary outcomes (4)

  1. OS

    Overall Survival (OS) from first dose of study drug until the time of data cut-off, as determined by the Investigator.

    Measured: the time from the first study treatment administration until death due to any cause, regardless of whether the patient withdraws from therapy or receives another anticancer therapy.

  2. ORR

    Objective Response Rate (ORR) of Target Lesion(s) and Non-Target Lesion(s)

    Measured: From date of enrollment until the date of first documented progression, assessed every 8 weeks up to 12 months.

  3. TTP

    Time to progression (TTP) of enrollment to disease progression as assessed by RECIST 1.1 and mRECIST.

    Measured: the time from the first study treatment administration until the first confirmed tumor progression (PD) based on the RECIST 1.1 assessment.

  4. Safety of durvalumab and tremelimumab in terms of the occurrence of adverse events

    changes from baseline in vital signs (blood pressure and heart rate), and safety laboratory findings (chemistry, hematology, and so on)

    Measured: Until 30 days after TACE or the last dose of tremelimumab and/or durvalumab

Timeline

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

  1. First posted4 Apr 2025
  2. Study start18 Apr 2025
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion30 Jun 2028 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
After the intravenous (IV) administration of 300 mg of tremelimumab and 1,500 mg of durvalumab, transarterial chemoembolization (TACE) will be performed in combination with 1,500 mg of durvalumab via IV infusion every 4 weeks (Q4W) until disease progression (PD) is confirmed. TACE will be carried out 1 to 2 weeks (7 to 14 days) after the administration of tremelimumab + durvalumab, and thereafter, it will be performed as needed at the discretion of the investigator during the treatment period. If additional TACE is performed, there must be at least a 1-week interval between the additional TACE and the administration of durvalumab.
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06911255
Sponsor's protocol ID
DETECT
Status last verified
May 2025
First submitted
8 Jan 2025
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Tremelimumab Plus Durvalumab (MEDI4736) and Transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Carcinoma, run by Yoon Jun Kim at 1 site in South Korea.

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 26 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Yoon Jun Kim, MD, PhD (82-2-2072-3081, yoonjun@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: the time from the first study treatment administration until the date of objective disease progression). 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 NCT06911255.

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 14 May 2025.

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