Hepatocellular CarcinomaPhase 2NCT02658019
Pembrolizumab (Keytruda) in Advanced Hepatocellular Carcinoma
A Phase 2 study testing Pembrolizumab in people with Hepatocellular Carcinoma, run by Lynn Feun, MD at 1 site in United States.
Trial summary
This is a single-arm phase II trial of Pembrolizumab (Keytruda) in patients with advanced, unresectable hepatocellular carcinoma. The primary objective is to assess its therapeutic efficacy in patients with unresectable hepatocellular carcinoma (HCC). 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2016to 17 Dec 2019
- 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
- Patients must have diagnosis of advanced hepatocellular cancer (HCC) by one of the following:
- Histopathology
- Elevated serum alpha-fetoprotein (AFP) >400 ng/ml and findings on magnetic resonance imaging (MRI) or computed tomography (CT) scans characteristic of HCC
- Findings on triple phase MRI or CT scans characteristic of HCC in patients with cirrhosis and tumors at least 1 cm or greater, without a curative treatment option (transplant, resection, or ablation).
- Measurable disease as defined by RECIST v1.1 (provided in Section 14.0).
- Radiographic progression on previously treated areas (as defined by RECIST v1.1).
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- Subject refusal for sorafenib treatment or intolerance to sorafenib are also allowed (intolerance is defined as ≥ 28 days of sorafenib (not necessarily consecutive) or ≥grade 3 toxicity due to sorafenib which does not resolve with appropriate supportive care).
- Patients should have failed at least one prior systemic therapy regimen which could include sorafenib. Patients may have progressed on sorafenib, been intolerant of, or refused sorafenib. Patients who are documented to refuse systemic chemotherapy or sorafenib are also eligible. No limit to prior systemic therapy. Prior locoregional therapy such as surgery, radiofrequency ablation or transarterial chemoembolization are also allowed, provided that progression has been documented after these therapies, and ≥4 weeks have elapsed since the last therapy; (these will not be counted as systemic therapy).
- Child-Pugh Classification with score ≤ 7 points. See Appendix G for criteria.
- Age ≥ 18 years
- Estimated life expectancy, in the judgement of the Investigator, of at least ≥ 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. See Appendix C.
- Adequate bone marrow function as defined below:
- absolute neutrophil count (ANC) ≥ 1.2 x 10^9/L,
- platelets (PLT) ≥ 50 x 10^9/L
- Adequate liver function as defined below:
- serum bilirubin < 2 mg/dl
- Aspartate transaminase (AST/SGOT) ≤ 5 x upper limit of normal (ULN),
- Alanine transaminase (ALT/SGPT) ≤ 5 x ULN
- Adequate coagulation as defined by:
- serum prothrombin time (PT) ≤ 16 seconds
- Adequate renal function as defined by one of the following:
- serum Creatinine ≤ 1.5 x ULN OR
- (measured or calculated) Creatinine clearance ≥ 60 mL/min for patients with serum creatinine levels > 1.5 x ULN.
- Suitable venous access to allow for all study-related blood sampling.
- Female subject of childbearing potential (CBP) must have a negative urine or serum pregnancy within 3 days prior to receiving the first dose of study medication.
- Females of child bearing potential that are sexually active must agree to either practice 2 medically accepted highly effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 120 days after the last dose of study drug. See Appendix H for protocol-approved highly effective methods of contraceptive combinations. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- Negative test for pregnancy is required of females of child-bearing potential; A female of child bearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
- has not undergone a hysterectomy or bilateral oophorectomy; or
- has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months or 730 days).
- Conception while on treatment must be avoided
- Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- 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 (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 years prior to the first dose of trial treatment.
- Major surgical procedure within 28 days prior to enrollment. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Any unresolved toxicity > CTCAE grade 2 despite optimal care/support, from previous anti-cancer therapy, within 28 days prior to first dose of study drug. [Exceptions: Alopecia and ≤grade 2 neuropathy.]
- Prior therapy with an anti-Programmed Death (PD)-1, anti-PD-Ligand-(L)-1, or anti-PD-L2 agent.
- Receipt of anti-cancer monoclonal antibody within 4 weeks prior to first dose of study drug.
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- Prior treatment with any other chemotherapy, radiotherapy, immunotherapy, or anticancer drug, agent or biologic within 4 weeks prior to first dose of study drug.
- Has received a live vaccine within 30 days of planned start of study therapy. 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.
- Receipt of any other investigational agents for their cancer ≤4 weeks of the first dose of study treatment.
- Known history of active Bacillus Tuberculosis (TB).
- Known history of, or any evidence of active, non-infectious pneumonitis or has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
- Known history of Human Immunodeficiency Virus (HIV), HIV-1/2 antibodies.
- Known hypersensitivity to pembrolizumab or any of its excipients.
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. [Exception: Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging, for at least 4 weeks prior to the first dose of study drug and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not apply to carcinomatous meningitis which is excluded regardless of clinical stability.]
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment.
- Any uncontrolled, intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
- Has a known additional malignancy that is progressing or requires active treatment. [Exception: Basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in situ cervical cancer.]
- Any other serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
- Treatment for active hepatitis C virus (HCV) within 60 days of study entry. [Note: Untreated HCV positive subjects are eligible, and if stable on pembrolizumab for 6 months after study entry, consideration may be given to starting anti-HCV therapy, at the discretion of the treating Investigator.]
- HCC patients with evidence of prior hepatitis B virus (HBV) must fulfill the following criteria in order to be eligible for the study: HBV viral load (VL) <100 IU/mL before study enrollment, and subjects with active HBV need to be on anti-HBV suppression ≥3 months, throughout treatment and for 6 months after.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Pembrolizumab (Keytruda®) in Advanced Hepatocellular Carcinoma (HCC)
This is a single-arm phase II trial of Pembrolizumab (Keytruda) in patients with advanced, unresectable hepatocellular carcinoma. The primary objective is to assess its therapeutic efficacy in patients with unresectable hepatocellular carcinoma (HCC).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Pembrolizumab
- Keywords
- Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma
- 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, MK-3475
Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab in Advanced HCC | Experimental | Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first. Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate (DCR) in Study Participants
Disease control rate (DCR) will be calculated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, as the percentage of patients with best overall response to protocol therapy of either complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 8 weeks.
Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1)for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: 8 weeks
Number of Participants With Treatment-Related Adverse Events
The safety of Pembrolizumab in HCC patients as measured by the incidence of treatment-related adverse events, including serious adverse events (SAEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, per physician discretion. The number of participants experiencing toxicity attributed by treating physician as definitely, probably and possibly-related to study treatment will be reported.
Measured: Up to 2 years
Secondary outcomes (4)
Progression-Free Survival (PFS)
Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier. For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .
Measured: Up to 25 months
Overall Survival (OS)
Overall survival (OS) will be defined as the elapsed time from the enrollment to death from any cause. For surviving patients, follow-up will be censored at the date of last contact (or last date known to be alive).
Measured: Up to 25 months
Objective Response Rate (ORR)
Objective response rate (ORR) will be defined as the percentage of the patients with a confirmed complete or partial response (CR or PR),by MRI or CT scan as per RECIST 1.1 criteria. Complete response (CR), Disappearance of all target lesions; Partial response (PR), >=30% decrease in sum of the longest diameter of target lesions; Overall response (OR) = (CR+PR.)Scans and assessments are performed every 9 weeks while on treatment up to 2 years if stable/responding, or up until time of disease progression.
Measured: Up to 2 years
Duration of Response (DoR)
Duration of Response (DoR) will be defined as the elapsed time from documented tumor response to documented disease progression.
Measured: Up to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study start6 May 2016
- Primary completion10 Nov 2019
- Study completion17 Dec 2019
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 (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lynn Feun, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Lynn Feun, MD, University of Miami
- Investigators
- Lynn Feun, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658019
- Sponsor's protocol ID
- 20151049
- Status last verified
- Oct 2020
- First submitted
- 14 Jan 2016
- Last updated
- 12 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Feun LG, Li YY, Wu C, Wangpaichitr M, Jones PD, Richman SP, Madrazo B, Kwon D, Garcia-Buitrago M, Martin P, Hosein PJ, Savaraj N. Phase 2 study of pembrolizumab and circulating biomarkers to predict anticancer response in advanced, unresectable hepatocellular carcinoma. Cancer. 2019 Oct 15;125(20):3603-3614. doi: 10.1002/cncr.32339. Epub 2019 Jun 28.
PubMed 31251403Zhou X, Cao J, Topatana W, Xie T, Chen T, Hu J, Li S, Juengpanic S, Lu Z, Zhang B, Wang K, Feng X, Shen J, Chen M. Evaluation of PD-L1 as a biomarker for immunotherapy for hepatocellular carcinoma: systematic review and meta-analysis. Immunotherapy. 2023 Apr;15(5):353-365. doi: 10.2217/imt-2022-0168. Epub 2023 Feb 27.
PubMed 36852452
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pembrolizumab (Keytruda®) in Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT02658019
- Acronym / sponsor ID
- 20151049
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Lynn Feun, MDUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 6 May 2016 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 17 Dec 2019 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Posted 12 Nov 2020
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 single-arm phase II trial of Pembrolizumab (Keytruda) in patients with advanced, unresectable hepatocellular carcinoma. The primary objective is to assess its therapeutic efficacy in patients with unresectable hepatocellular carcinoma (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab in Advanced HCC | Experimental | Drug: PembrolizumabPatients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. Trial therapy will last until withdrawal of consent, disease progression and/or unacceptable toxicity, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Patients must have diagnosis of advanced hepatocellular cancer (HCC) by one of the following:
- Measurable disease as defined by RECIST v1.1 (provided in Section 14.0).
- Radiographic progression on previously treated areas (as defined by RECIST v1.1).
- Subject refusal for sorafenib treatment or intolerance to sorafenib are also allowed (intolerance is defined as ≥ 28 days of sorafenib (not necessarily consecutive) or ≥grade 3 toxicity due to sorafenib which does not resolve with appropriate supportive care).
- Patients should have failed at least one prior systemic therapy regimen which could include sorafenib. Patients may have progressed on sorafenib, been intolerant of, or refused sorafenib. Patients who are documented to refuse systemic chemotherapy or sorafenib are also eligible. No limit to prior systemic therapy. Prior locoregional therapy such as surgery, radiofrequency ablation or transarterial chemoembolization are also allowed, provided that progression has been documented after these therapies, and ≥4 weeks have elapsed since the last therapy; (these will not be counted as systemic therapy).
Key exclusion criteria (20 listed)
- 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 (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 years prior to the first dose of trial treatment.
- Major surgical procedure within 28 days prior to enrollment. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Any unresolved toxicity > CTCAE grade 2 despite optimal care/support, from previous anti-cancer therapy, within 28 days prior to first dose of study drug. [Exceptions: Alopecia and ≤grade 2 neuropathy.]
- Prior therapy with an anti-Programmed Death (PD)-1, anti-PD-Ligand-(L)-1, or anti-PD-L2 agent.
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: Keytruda, MK-3475Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle. | Drug | Pembrolizumab in Advanced HCC |
Primary outcome
Disease Control Rate (DCR) in Study Participants
Time frame: 8 weeks
Disease control rate (DCR) will be calculated per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, as the percentage of patients with best overall response to protocol therapy of either complete response (CR), partial response (PR) or stable disease (SD) that is maintained for at least 8 weeks. Per Response Evaluation Criteria in Sold Tumors Criteria (RECISTv1.1)for target lesions and assessed by MRI or CT: Complete response(CR),Disappearance of all target lesions; Partial response(PR),>=30% decrease in sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Number of Participants With Treatment-Related Adverse Events
Time frame: Up to 2 years
The safety of Pembrolizumab in HCC patients as measured by the incidence of treatment-related adverse events, including serious adverse events (SAEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, per physician discretion. The number of participants experiencing toxicity attributed by treating physician as definitely, probably and possibly-related to study treatment will be reported.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 25 months
Overall Survival (OS)
Time frame: Up to 25 months
Objective Response Rate (ORR)
Time frame: Up to 2 years
Duration of Response (DoR)
Time frame: Up to 3 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31251403Feun LG, Li YY, Wu C, Wangpaichitr M, Jones PD, Richman SP, Madrazo B, Kwon D, Garcia-Buitrago M, Martin P, Hosein PJ, Savaraj N. Phase 2 study of pembrolizumab and circulating biomarkers to predict anticancer response in advanced, unresectable hepatocellular carcinoma. Cancer. 2019 Oct 15;125(20):3603-3614. doi: 10.1002/cncr.32339. Epub 2019 Jun 28.
- Derived from this study: PubMed 36852452Zhou X, Cao J, Topatana W, Xie T, Chen T, Hu J, Li S, Juengpanic S, Lu Z, Zhang B, Wang K, Feng X, Shen J, Chen M. Evaluation of PD-L1 as a biomarker for immunotherapy for hepatocellular carcinoma: systematic review and meta-analysis. Immunotherapy. 2023 Apr;15(5):353-365. doi: 10.2217/imt-2022-0168. Epub 2023 Feb 27.
- 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.
Lynn Feun, MD principal investigator
University of Miami
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 Pembrolizumab in people with Hepatocellular Carcinoma, run by Lynn Feun, MD 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 33 inclusion and 20 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 12 Nov 2020. 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 12 Nov 2020). 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?
Disease Control Rate (DCR) in Study Participants (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT02658019, which also lists 2 linked publications.
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 12 Nov 2020.