Intermediate Stage of Hepatocellular CarcinomaPhase 2NCT03638141
CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab
A Phase 2 study testing Durvalumab and Tremelimumab in people with Intermediate Stage of Hepatocellular Carcinoma and Hepatocellular Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intermediate Stage of Hepatocellular Carcinoma, Hepatocellular Carcinoma
- What is being tested?
- Durvalumab and Tremelimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2019to 20 Aug 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed informed consent form
- Age ≥18 years.
- Patients with diagnosis of HCC either by high-resolution imaging (triple-phase CT or MRI) and/or by tumor biopsy.
- Patient is not on systemic treatment for diagnosis of HCC
- HCC meeting Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage), with measurable lesions on CT or MRI and without extrahepatic spread
- Have measurable disease
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- Have disease that responds to DEB-TACE
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Child-Pugh Score of A or early B (score ≤8) without clinically significant ascites
- Body weight >30 kg
- Patients must have adequate organ function defined by study-specified laboratory tests.
- Evidence of post-menopausal status or negative pregnancy test
- Willing and able to comply with study procedures
- Willing to undergo a liver biopsy
Who cannot join
- Anyone involved with the planning and/or conduct of the study.
- Has participated in another investigational study during the last 6 months.
- Any concurrent anticancer therapy or received therapy ≤30 days prior to study.
- Major surgical procedure at the time of study enrollment or within 28 days prior to the first dose of study drug.
- Have a vascular invasion or extrahepatic tumor.
- Main portal vein thrombosis present on imaging.
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- Uncontrolled hepatic encephalopathy at time of enrollment. - Ascites within 6 weeks prior to study treatment.
- Any contraindications for embolization.
- Has an active infection such as Tuberculosis, HIV, hepatitis B or C.
- History of another primary malignancy or myeloproliferative disorder.
- History of leptomeningeal carcinomatosis.
- History of active primary immunodeficiency.
- Any unresolved toxicities from previous anticancer therapy.
- Active or prior documented GI bleeding due to ulcer or esophageal varices bleeding within 6 months.
- History or current use of immunosuppressive medications within 14 days prior to study medications.
- Major surgical procedure within 28 days prior to the first dose of IP.
- Has an active known or suspected autoimmune disease.
- Patients with hypothyroidism.
- Any active skin conditions.
- History of allogenic organ transplantation.
- Significant heart disease.
- Patients weighing < 30 kg.
- Patients with celiac disease not controlled by diet alone.
- Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Have received a live vaccine within 30 days prior to study drug.
- Woman who are pregnant or breastfeeding.
- Known allergy or hypersensitivity to the study drug.
- Have received durvalumab, tremelimumab, anti-PD-1, anti-PD-L1 or anti-CTLA-4 in a prior study.
- Unwilling or unable to follow the study schedule for any reason.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
About this study
Official title: The Effect of CTLA-4/PD-L1 Blockade Following Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC Using Durvalumab (MEDI4736) and Tremelimumab
The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.
- Being tested
- Durvalumab, Tremelimumab
- Keywords
- HCC, Durvalumab, Tremelimumab, Immunotherapy, PD-L1, Antibodies, Hepatocellular Carcinoma, CTLA-4, DEB-TACE
- Medical subject headings
- Carcinoma, Hepatocellular, Diabetes Mellitus, Insulin-Dependent, 12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736
Durvalumab 1500mg IV every 4 weeks for up to a maximum of 13 cycles (about 12 months) or until confirmed disease progression.
TremelimumabDrug
Also called CP-675,206
Tremelimumab 300 mg IV in combination with Durvalumab 1500mg about 2 weeks after their first DEB-TACE.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab in combination with Tremelimumab | Experimental | Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure.
Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 doses/cycles. Receives: Drug: Durvalumab; Drug: Tremelimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on mRECIST criteria. CR = Disappearance of any intratumoral arterial enhancement in all target lesions, PR = At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
Measured: up to 26 months
Secondary outcomes (3)
Drug-related Toxicity
Number of participants experiencing drug-related adverse events (AE) Grade 3 or higher as defined by CTCAE v5.0
Measured: up to 16 months
Progression Free Survival (PFS)
Progression free survival is defined as the time from start of the treatment until the documentation of disease progression according to mRECIST or death due to any cause, whichever occurs first. Estimation based on the Kaplan-Meier curve.
Measured: up to 58 months
Overall Survival (OS)
Overall survival is the time from the start of first dose of study drug to death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Measured: up to 58 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start2 Oct 2019
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intermediate Stage of Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Ana De Jesus-Acosta, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638141
- Sponsor's protocol ID
- J18118
- Other IDs
- IRB00179347
- Status last verified
- Jul 2025
- First submitted
- 15 Aug 2018
- Last updated
- 17 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of CTLA-4/PD-L1 Blockade Following Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC Using Durvalumab (MEDI4736) and Tremelimumab
- ClinicalTrials.gov ID
- NCT03638141
- Acronym / sponsor ID
- J18118
- Keywords
- HCC, Durvalumab, Tremelimumab, Immunotherapy, PD-L1, Antibodies, Hepatocellular Carcinoma, CTLA-4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 2 Oct 2019 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 20 Aug 2018 (actual)
- Results
- Posted 17 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab in combination with Tremelimumab | Experimental | Drug: Durvalumab, Drug: TremelimumabDrug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure. Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 doses/cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed informed consent form
- Age ≥18 years.
- Patients with diagnosis of HCC either by high-resolution imaging (triple-phase CT or MRI) and/or by tumor biopsy.
- Patient is not on systemic treatment for diagnosis of HCC
- HCC meeting Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage), with measurable lesions on CT or MRI and without extrahepatic spread
Key exclusion criteria (29 listed)
- Anyone involved with the planning and/or conduct of the study.
- Has participated in another investigational study during the last 6 months.
- Any concurrent anticancer therapy or received therapy ≤30 days prior to study.
- Major surgical procedure at the time of study enrollment or within 28 days prior to the first dose of study drug.
- Have a vascular invasion or extrahepatic tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736Durvalumab 1500mg IV every 4 weeks for up to a maximum of 13 cycles (about 12 months) or until confirmed disease progression. | Drug | Durvalumab in combination with Tremelimumab |
| TremelimumabAlso: CP-675,206Tremelimumab 300 mg IV in combination with Durvalumab 1500mg about 2 weeks after their first DEB-TACE. | Drug | Durvalumab in combination with Tremelimumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 26 months
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on mRECIST criteria. CR = Disappearance of any intratumoral arterial enhancement in all target lesions, PR = At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
3 secondary outcomes
Drug-related Toxicity
Time frame: up to 16 months
Progression Free Survival (PFS)
Time frame: up to 58 months
Overall Survival (OS)
Time frame: up to 58 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana De Jesus-Acosta, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab and Tremelimumab in people with Intermediate Stage of Hepatocellular Carcinoma and Hepatocellular Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
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 14 inclusion and 29 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: finished, as of the sponsor's last update on 17 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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) (time frame: up to 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2025.