Hepatocellular CarcinomaPhase 2PRIMER-1NCT05185739
Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
A Phase 2 study testing Pembrolizumab, Lenvatinib and Pembrolizumab and Lenvatinib in people with Hepatocellular Carcinoma, run by University College, London at 11 sites in United Kingdom.
Trial summary
This is a multicentre randomised 3-arm phase II clinical trial in patients with resectable Hepatocellular Carcinoma (HCC). Sixty patients will be randomized 1:1:1 to 6 weeks of pre-operative therapy with: pembrolizumab, lenvatinib or the combination of pembrolizumab and lenvatinib followed by up to 12 months treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Pembrolizumab, Lenvatinib and Pembrolizumab and Lenvatinib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 25 Aug 2022to Jul 2030
- 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
- Have a diagnosis of Hepatocellular Carcinoma (HCC) confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) and suitable for surgical resection. Radiological confirmation of diagnosis is provided by the study site and defined by the presence of a liver mass of at least 1 cm and exhibiting arterial hypervascularity with washout in the portal venous phase seen in a tri-phasic magnetic resonance imaging (MRI).
- Measurable disease based on RECIST 1.1
- HCC amenable to R0 resection with curable intent
- Child-Pugh A liver disease
- International normalised ratio (INR) ≤1.4
- ECOG Performance status 0 or 1
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- Adequate haematological function as defined by:
- Haemoglobin (Hb) > 90g/l
- Neutrophil Count > 1.5 x 109/l
- Platelets > 75 x 109/l
- Adequate renal function with GFR >40ml/min using a validated creatinine clearance calculation (e.g. Cockcroft-Gault or Wright formula)
- Adequate liver function as defined by:
- Aminotransferase (ALT) or aspartate aminotransferase (AST) < 5.0 x ULN
- Albumin >32g/l
- Amylase ≤ 1.5 x ULN
- Patients with past or ongoing hepatitis C virus (HCV) infection will be eligible for the study if HCV viral load is undetectable at screening. The treated patients must have completed their treatment curative anti-viral treatment at least 4 weeks prior to randomisation.
- Patients with controlled hepatitis B will be eligible as long as they meet the following criteria:
- Antiviral therapy for hepatitis B virus (HBV) must be given for at least 4 weeks and HBV viral load must be less than 500 IU/mL prior to randomisation. Patients on active HBV therapy with viral loads under 500 IU/mL should stay on the same therapy throughout study treatment.
- Patients who are positive for anti-hepatitis B core antibody (HBc), negative for hepatitis B surface antigen (HBsAg), and negative or positive for anti-hepatitis B surface antibody (HBs), and who have an HBV viral load under 500 IU/mL, do not require HBV anti-viral prophylaxis
- 18 years of age or over
- Predicted life expectancy of > 3 months
- Patients must have given written informed consent
- Patients must have the ability to swallow oral medication
- Must be willing to use effective contraception during study for 120 days after last dose.
Who cannot join
- Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable HCC.
- Has received local therapy including trans arterial embolic, chemo- or radiotherapy, external beam radiotherapy or ablative therapy to the measurable lesion to be resected.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, or CD137).
- Oesophageal or gastric variceal bleeding within the last 6 months.
- Has received a live vaccine within 30 days prior to registration (seasonal flu vaccines that do not contain live virus are permitted). Administration of killed vaccines is allowed.
- Active autoimmune disease that has required systemic treatment (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs) in past 2 years except
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- Vitiligo
- Psoriasis
- Autoimmune-related hyperthyroidism
- Autoimmune-related hypothyroidism who are in remission or on a stable dose of thyroid-replacement hormone replacement therapy (e.g., levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- A diagnosis of immunodeficiency or is receiving systemic steroid therapy (>10mg daily prednisolone equivalent) or any other form of immunosuppressive therapy within 7 days prior to treatment.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has clinical or radiological evidence of ascites on physical examination that is not controlled with medication.
- Uncontrolled blood pressure (Systolic BP)>150 mmHg or diastolic BP >90 mmHg) with no change in anti-hypertensive medications within 1 week prior to randomisation.
- Has had clinically diagnosed hepatic encephalopathy in the last 6 months.
- Has medical contraindications that preclude all forms of contrast enhanced imaging (tri-phasic CT or MRI).
- Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
- Has a pre-existing Grade ≥3 gastrointestinal or non-gastrointestinal fistula.
- Clinically significant haemoptysis from any source or tumour bleeding within 2 weeks prior to start of treatment.
- Electrolyte abnormalities that have not been corrected.
- Significant cardiovascular impairment within 12 months of start of treatment such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of start of treatment, or cardiac arrhythmia requiring medical treatment at screening.
- Prolongation of QTc interval to > 480 ms.
- Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).
- Patients who are at risk for severe haemorrhage, bleeding or thrombotic disorders, or are receiving factor X inhibitors or anticoagulants that require therapeutic INR monitoring e.g. warfarin or similar agents. The degree of tumour invasion/infiltration of major blood vessels should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.
- Patients having > 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is <1 g/24 hours.
- Patients who have not recovered adequately from any toxicity from other anti- cancer treatment regimens and/or complications from major surgery prior to starting therapy.
- Has had major surgery to the liver prior to start of treatment. Note: If patient received any major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Has had a minor surgery (i.e., simple excision) within 7 days prior to start of treatment (Cycle 1 Day 1).
- Has a serious non-healing wound, ulcer, or bone fracture.
- History of human immunodeficiency virus (HIV) infection.
- Has an active infection requiring systemic therapy, with the exception of HBV, HCV.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab or lenvatinib and/or any of their excipients.
- Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and HCV infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry.
- Has dual active HBV infection and hepatitis D virus (HDV) at the study entry.
- Has a known history of active tuberculosis (Bacillus tuberculosis).
- Has a known psychiatric or substance abuse disorder that would interfere with the patient's ability to cooperate with the requirements of the study.
- Is currently participating in 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 intervention. Note: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has had an allogenic tissue/solid organ transplant.
- Women who are pregnant or breast feeding.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Have extra-hepatic spread or macrovascular invasion.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United Kingdom11 sites, 11 recruiting
- Recruiting
Queen Elizabeth Hospital
Birmingham
Yuk-Ting Ma
- Recruiting
Addenbrooke's Hospital
Cambridge
Bristi Basu
- Not yet recruiting
Western General Hospital
Edinburgh, EH4 2XU
Alan Christie
- Not yet recruiting
Beatson West of Scotland Cancer Centre
Glasgow
Jeff Evans
- Not yet recruiting
St James's Hospital
Leeds
Daniel Swinson
- Not yet recruiting
Clatterbridge Cancer Centre
Liverpool
Daniel Palmer
- Recruiting
Hammersmith Hospital
London
Rohini Sharma
- Recruiting
King's College Hospital
London
Paul Ross
- Recruiting
Royal Free Hospital
London
Tim Meyer
- Not yet recruiting
The Christie NHS Foundation Trust
Manchester
Richard Hubner
- Recruiting
Freeman Hospital
Newcastle upon Tyne
Sanjay Pandanaboyana
About this study
Official title: PRIMER-1 Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
This is a multicentre randomised 3-arm phase II clinical trial in patients with resectable Hepatocellular Carcinoma (HCC). Sixty patients will be randomized 1:1:1 to 6 weeks of pre-operative therapy with: pembrolizumab, lenvatinib or the combination of pembrolizumab and lenvatinib followed by up to 12 months treatment with post-operative pembrolizumab. The aim of the study is to compare the efficacy of pembrolizumab combined with lenvatinib with that of pembrolizumab and lenvatinib alone in terms of major pathological response in patients with resectable HCC. Major pathological response will be defined by the proportion of patients with less than 10% viable tumour at resection.
Read the detailed description
Hepatocellular Carcinoma (HCC), or Liver cancer, is the second most common cause of cancer-related death worldwide and is the most rapidly increasing cause of cancer-related death in the West. The only potentially curative options are transplantation, surgical resection and ablation. Both surgical resection and ablation are associated with a high rate of recurrence and 70% of resected patients relapse within 5 years. To date, no standard adjuvant therapies have been approved. Recent studies provide evidence that immunotherapy may address a significant unmet need in the management of HCC.
Furthermore, there is also a rationale for pre-operative therapy which has been shown to be superior to a postoperative treatment approach as supported by pre-clinical studies. The feasibility and outcomes of this approach have recently been reported in the setting of lung cancer. Lenvatinib, an immunotherapy drug, has been approved as a first treatment option in HCC. Pembrolizumab, another immunotherapy treatment has been evaluated as first treatment option in HCC in two clinical trials. The combination of these two drugs has been explored in HCC in early phase trials.
The aim is to compare the efficacy of pembrolizumab (a type of immunotherapy designed to 're-awaken' the immune system) combined with lenvatinib (an anti-cancer drug that is a multiple kinase inhibitor) with that of pembrolizumab and lenvatinib alone in patients with resectable Hepatocellular Carcinoma.
Treatment lasts for up to 18 months. Depending on when patients are recruited, patients will be followed up for a minimum of 1 year and maximum of 3 years, following the end of their post-surgery treatment. It is expected that it will take 24 months to recruit all the patients.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Pembrolizumab, Lenvatinib, Pembrolizumab and Lenvatinib
- Keywords
- Liver cancer,, pembrolizumab, lenvatinib
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pre-operative Pembrolizumab (200mg IV every 3 weeks) for 2 cycles
LenvatinibDrug
Pre-operative Lenvatinib (8 or 12mg PO once daily according to bodyweight <60gk≥) for 6 weeks
Pembrolizumab and LenvatinibDrug
Pre-operative combination of pembrolizumab and lenvatinib at the standard doses and duration as per cohort 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Active comparator | Not described Receives: Drug: Pembrolizumab |
| Lenvatinib. | Active comparator | Not described Receives: Drug: Lenvatinib |
| Pembrolizumab and Lenvatinib. | Experimental | Not described Receives: Drug: Pembrolizumab and Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response rate, defined as the proportion of patients with less than 10% viable tumour at resection.
The primary aim of the study is to test the hypothesis that the combination of pembrolizumab and lenvatinib result in a higher rate of major pathological response than either drug used as a single-agent in patients with resectable hepatocellular carcinoma.
Measured: At 4 months
Secondary outcomes (8)
Percentage of viable tumour cells at resection
The primary aim of the study is to test the hypothesis that the combination of pembrolizumab and lenvatinib result in a higher rate of major pathological response than either drug used as a single-agent in patients with resectable hepatocellular carcinoma.
Measured: At 4 months
Radiological response rate
The hypothesis is that the radiological response rate of pembrolizumab and lenvatinib in combination is greater than that of pembrolizumab and lenvatinib as single agents. Measured by RECIST 1.1 and mRECIST performed pre-operatively and compared with pre-treatment baseline imaging)
Measured: Evaluated pre-surgery (at 2 months)
Relapse free survival at 12 months from surgery
Relapse free survival at 12 months from surgery
Measured: 12 months from surgery
Proportion of patients with surgery delayed by more than 4 weeks from the planned surgery date
Defined as the proportion of patients with surgery delayed by more than 4 weeks from the planned surgery date due to IMP-related adverse events (AEs) or serious adverse events (SAEs))
Measured: Evaluated by time to surgery (at 3 months)
30-day post-operative surgical complication rate
based on the Clavien-Dindo classification
Measured: Evaluated 30 days post surgery
Completion of protocol-defined therapy
measured by the proprtion of patients mpleting protocol defined study-drug intervention.
Measured: 6 weeks pre-operative
Completion of protocol-defined therapy
measured by the proprtion of patients mpleting protocol defined study-drug intervention.
Measured: 12 months post-operative
Determine the toxicity of pre-operative therapy according to Common Terminology Criteria for Adverse Events (CTCAE) V5.
Incidence and of adverse events (AEs) reported. Events will be classified according to CTCAE V5.0
Measured: Evaluated by monthly follow-up until patient relapse/ maximum of 3 years, following the end of their post-surgery treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start25 Aug 2022
- Primary completionJul 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised 3-arm phase II clinical trial in patients with resectable HCC. Sixty patients will be randomized 1:1:1 to pembrolizumab, lenvatinib or the combination of pembrolizumab and lenvatinib.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Tim Meyer, BSc MBBS PhD FRCP, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185739
- Sponsor's protocol ID
- UCL/12/6928
- Acronym
- PRIMER-1
- Status last verified
- Dec 2024
- First submitted
- 2 Nov 2021
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRIMER-1 Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT05185739
- Acronym / sponsor ID
- PRIMER-1 / UCL/12/6928
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Liver cancer,, pembrolizumab, lenvatinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 11 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicentre randomised 3-arm phase II clinical trial in patients with resectable Hepatocellular Carcinoma (HCC). Sixty patients will be randomized 1:1:1 to 6 weeks of pre-operative therapy with: pembrolizumab, lenvatinib or the combination of pembrolizumab and lenvatinib followed by up to 12 months treatment with post-operative pembrolizumab. The aim of the study is to compare the efficacy of pembrolizumab combined with lenvatinib with that of pembrolizumab and lenvatinib alone in terms of major pathological response in patients with resectable HCC. Major pathological response will be defined by the proportion of patients with less than 10% viable tumour at resection.
Detailed description
Hepatocellular Carcinoma (HCC), or Liver cancer, is the second most common cause of cancer-related death worldwide and is the most rapidly increasing cause of cancer-related death in the West. The only potentially curative options are transplantation, surgical resection and ablation. Both surgical resection and ablation are associated with a high rate of recurrence and 70% of resected patients relapse within 5 years. To date, no standard adjuvant therapies have been approved. Recent studies provide evidence that immunotherapy may address a significant unmet need in the management of HCC.
Furthermore, there is also a rationale for pre-operative therapy which has been shown to be superior to a postoperative treatment approach as supported by pre-clinical studies. The feasibility and outcomes of this approach have recently been reported in the setting of lung cancer. Lenvatinib, an immunotherapy drug, has been approved as a first treatment option in HCC. Pembrolizumab, another immunotherapy treatment has been evaluated as first treatment option in HCC in two clinical trials. The combination of these two drugs has been explored in HCC in early phase trials.
The aim is to compare the efficacy of pembrolizumab (a type of immunotherapy designed to 're-awaken' the immune system) combined with lenvatinib (an anti-cancer drug that is a multiple kinase inhibitor) with that of pembrolizumab and lenvatinib alone in patients with resectable Hepatocellular Carcinoma.
Treatment lasts for up to 18 months. Depending on when patients are recruited, patients will be followed up for a minimum of 1 year and maximum of 3 years, following the end of their post-surgery treatment. It is expected that it will take 24 months to recruit all the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomised 3-arm phase II clinical trial in patients with resectable HCC. Sixty patients will be randomized 1:1:1 to pembrolizumab, lenvatinib or the combination of pembrolizumab and lenvatinib.
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab | Active comparator | Drug: Pembrolizumab |
| Lenvatinib. | Active comparator | Drug: Lenvatinib |
| Pembrolizumab and Lenvatinib. | Experimental | Drug: Pembrolizumab and Lenvatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Have a diagnosis of Hepatocellular Carcinoma (HCC) confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) and suitable for surgical resection. Radiological confirmation of diagnosis is provided by the study site and defined by the presence of a liver mass of at least 1 cm and exhibiting arterial hypervascularity with washout in the portal venous phase seen in a tri-phasic magnetic resonance imaging (MRI).
- Measurable disease based on RECIST 1.1
- HCC amenable to R0 resection with curable intent
- Child-Pugh A liver disease
- International normalised ratio (INR) ≤1.4
Key exclusion criteria (42 listed)
- Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable HCC.
- Has received local therapy including trans arterial embolic, chemo- or radiotherapy, external beam radiotherapy or ablative therapy to the measurable lesion to be resected.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, or CD137).
- Oesophageal or gastric variceal bleeding within the last 6 months.
- Has received a live vaccine within 30 days prior to registration (seasonal flu vaccines that do not contain live virus are permitted). Administration of killed vaccines is allowed.
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 |
|---|---|---|
| PembrolizumabPre-operative Pembrolizumab (200mg IV every 3 weeks) for 2 cycles | Drug | Pembrolizumab |
| LenvatinibPre-operative Lenvatinib (8 or 12mg PO once daily according to bodyweight <60gk≥) for 6 weeks | Drug | Lenvatinib. |
| Pembrolizumab and LenvatinibPre-operative combination of pembrolizumab and lenvatinib at the standard doses and duration as per cohort 1 and 2 | Drug | Pembrolizumab and Lenvatinib. |
Primary outcome
Major pathological response rate, defined as the proportion of patients with less than 10% viable tumour at resection.
Time frame: At 4 months
The primary aim of the study is to test the hypothesis that the combination of pembrolizumab and lenvatinib result in a higher rate of major pathological response than either drug used as a single-agent in patients with resectable hepatocellular carcinoma.
8 secondary outcomes
Percentage of viable tumour cells at resection
Time frame: At 4 months
Radiological response rate
Time frame: Evaluated pre-surgery (at 2 months)
Relapse free survival at 12 months from surgery
Time frame: 12 months from surgery
Proportion of patients with surgery delayed by more than 4 weeks from the planned surgery date
Time frame: Evaluated by time to surgery (at 3 months)
30-day post-operative surgical complication rate
Time frame: Evaluated 30 days post surgery
Completion of protocol-defined therapy
Time frame: 6 weeks pre-operative
Completion of protocol-defined therapy
Time frame: 12 months post-operative
Determine the toxicity of pre-operative therapy according to Common Terminology Criteria for Adverse Events (CTCAE) V5.
Time frame: Evaluated by monthly follow-up until patient relapse/ maximum of 3 years, following the end of their post-surgery treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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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.
Tim Meyer, BSc MBBS PhD FRCP principal investigator
University College, London
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Lenvatinib and Pembrolizumab and Lenvatinib in people with Hepatocellular Carcinoma, run by University College, London at 11 sites 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 24 inclusion and 42 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 6 Dec 2024. 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 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 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?
Contact Michelle Hung (+44 20 7679 9887, ctc.primer1@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response rate, defined as the proportion of patients with less than 10% viable tumour at resection. (time frame: At 4 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 6 Dec 2024.