Primary Liver CarcinomaPhase 1/2PETALNCT03397654
Study of Pembrolizumab Following TACE in Primary Liver Carcinoma
A Phase 1/2 study testing Pembrolizumab and Trans-arterial chemoembolization in people with Primary Liver Carcinoma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Open label, single arm, multi-centre study of pembrolizumab following trans-arterial chemoembolization (TACE). Twenty-six to 32 evaluable participants with primary liver cancer (hepatocellular cancer; HCC) will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Liver Carcinoma
- What is being tested?
- Pembrolizumab and Trans-arterial chemoembolization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jan 2018to 23 Mar 2023
- Phase
- Phase 1/2
- 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
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Be willing to provide tissue from an excisional biopsy of a tumour lesion.
- Have at least one uni-dimensional lesion measurable by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI) based on mRECIST criteria.
- Be ineligible for surgical resection or liver transplantation.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
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- Demonstrate adequate organ function
- Have an overall Child-Pugh score <7
- Female subject of childbearing potential should have a negative urine or serum pregnancy. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Women of childbearing potential must be willing to use a highly effective method of contraception as outlined in Section 6.9.2 for the course of the study through 120 days after the last dose of Investigational Medicinal Product (IMP). Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
- Sexually active males must agree to use an adequate method of contraception as outlined in Section 6.9.2 starting with the first dose of IMP through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Who cannot join
- Has extrahepatic metastasis.
- Prior TACE or systemic anticancer treatment for HCC.
- Has any contraindication for TACE including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis.
- Has history of bleeding within the 4 weeks preceding study enrolment.
- Has hepatic encephalopathy.
- Has ascites that is refractory to diuretic therapy.
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- Has documented occlusion of the hepatic artery or the main portal vein (segmental portal vein thrombosis does not represent exclusion criterion provided this does not contraindicate TACE).
- Is currently participating and receiving therapy or has participated or is participating in a study of an IMP or used an investigational device within 4 weeks of the first dose of IMP.
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy.
- Has a known history of active Bacillus Tuberculosis (TB)
- Hypersensitivity to Pembrolizumab or any of its excipients.
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has known history of, or any evidence of active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy. Exceptions relating to Hepatitis B and C virus infection are documented in Section 5.3.1, Table 5.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Principal Investigator (PI).
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through to 120 days after the last dose of IMP.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent.
- Has a known history of Human Immunodeficiency Virus (HIV; HIV 1/2 antibodies).
- Has received a live vaccine within 30 days of first dose of IMP administration. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Study of Pembrolizumab Following Trans-Arterial Chemoembolization in Primary Liver Carcinoma
Open label, single arm, multi-centre study of pembrolizumab following trans-arterial chemoembolization (TACE). Twenty-six to 32 evaluable participants with primary liver cancer (hepatocellular cancer; HCC) will be assessed. The primary objective is to determine the safety and tolerability of pembrolizumab following TACE. The secondary objective is to evaluate the efficacy of pembrolizumab following TACE by improving progression-free survival rates as measured by modified response evaluation criteria in solid tumours (mRECIST) criteria.
- Conditions
- Primary Liver Carcinoma
- Being tested
- Pembrolizumab, Trans-arterial chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called KEYTRUDA
Pembrolizumab solution
Trans-arterial chemoembolizationCombination product
Also called TACE
Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
| Study group | Role | What they receive |
|---|---|---|
| TACE followed by pembrolizumab | Experimental | Trans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year Receives: Drug: Pembrolizumab; Combination Product: Trans-arterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events (Safety and Tolerability)
The safety and tolerability of pembrolizumab will be assessed by recording the incidence of adverse events (AEs) using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4).
Measured: from the first pembrolizumab administration to up to 130 days after the last dose, 1.5 years
Secondary outcomes (1)
Progression-free Survival Rate (PFS; Efficacy) at 12 Weeks
PFS was defined by the time from last TACE to the first occurrence of documented disease progression based on RECIST v1.1 criteria or death from any cause, whichever occurred first, and it was calculated using Kaplan-Meier.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study start28 Jan 2018
- Primary completion1 Feb 2023
- Study completion23 Mar 2023
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Liver CarcinomaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397654
- Sponsor's protocol ID
- PETAL1
- Acronym
- PETAL
- Status last verified
- Mar 2025
- First submitted
- 1 Dec 2017
- Last updated
- 6 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fessas P, Scheiner B, D'Alessio A, M Fulgenzi CA, Korolewicz J, Ward C, Tait P, Thomas R, Cortellini A, Sharma R, Pinato DJ. PETAL protocol: a phase Ib study of pembrolizumab after transarterial chemoembolization in hepatocellular carcinoma. Future Oncol. 2023 Mar;19(7):499-507. doi: 10.2217/fon-2022-0916. Epub 2023 Apr 25.
PubMed 37097715
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of Pembrolizumab Following Trans-Arterial Chemoembolization in Primary Liver Carcinoma
- ClinicalTrials.gov ID
- NCT03397654
- Acronym / sponsor ID
- PETAL / PETAL1
- Conditions
- Primary Liver Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 12 Jan 2018 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open label, single arm, multi-centre study of pembrolizumab following trans-arterial chemoembolization (TACE). Twenty-six to 32 evaluable participants with primary liver cancer (hepatocellular cancer; HCC) will be assessed. The primary objective is to determine the safety and tolerability of pembrolizumab following TACE. The secondary objective is to evaluate the efficacy of pembrolizumab following TACE by improving progression-free survival rates as measured by modified response evaluation criteria in solid tumours (mRECIST) criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE followed by pembrolizumab | Experimental | Drug: Pembrolizumab, Combination Product: Trans-arterial chemoembolizationTrans-arterial chemoembolization (TACE) using doxorubicin solution (60 mg dose) and gelatin sponge particles; followed, at least 30 or 45 days later, by pembrolizumab solution (200 mg dose) every 3 weeks for a maximum of 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be willing and able to provide written informed consent/assent for the trial.
- Be ≥ 18 years of age on day of signing informed consent.
- Be willing to provide tissue from an excisional biopsy of a tumour lesion.
- Have at least one uni-dimensional lesion measurable by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI) based on mRECIST criteria.
- Be ineligible for surgical resection or liver transplantation.
Key exclusion criteria (21 listed)
- Has extrahepatic metastasis.
- Prior TACE or systemic anticancer treatment for HCC.
- Has any contraindication for TACE including portosystemic shunt, hepatofugal blood flow, known severe atheromatosis.
- Has history of bleeding within the 4 weeks preceding study enrolment.
- Has hepatic encephalopathy.
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 |
|---|---|---|
| PembrolizumabAlso: KEYTRUDAPembrolizumab solution | Drug | TACE followed by pembrolizumab |
| Trans-arterial chemoembolizationAlso: TACEDoxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour | Combination product | TACE followed by pembrolizumab |
Primary outcome
Incidence of Treatment-emergent Adverse Events (Safety and Tolerability)
Time frame: from the first pembrolizumab administration to up to 130 days after the last dose, 1.5 years
The safety and tolerability of pembrolizumab will be assessed by recording the incidence of adverse events (AEs) using National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (NCI CTCAE v4).
1 secondary outcome
Progression-free Survival Rate (PFS; Efficacy) at 12 Weeks
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37097715Fessas P, Scheiner B, D'Alessio A, M Fulgenzi CA, Korolewicz J, Ward C, Tait P, Thomas R, Cortellini A, Sharma R, Pinato DJ. PETAL protocol: a phase Ib study of pembrolizumab after transarterial chemoembolization in hepatocellular carcinoma. Future Oncol. 2023 Mar;19(7):499-507. doi: 10.2217/fon-2022-0916. Epub 2023 Apr 25.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pembrolizumab and Trans-arterial chemoembolization in people with Primary Liver Carcinoma, run by Imperial College London at 1 site in United Kingdom.
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 11 inclusion and 21 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 6 Mar 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 3 Feb 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?
Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) (time frame: from the first pembrolizumab administration to up to 130 days after the last dose, 1.5 years). 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 NCT03397654, which also lists 1 linked publication.
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 6 Mar 2025.