Liver CancerEarly Phase 1NCT03143270
A Study to Test the Safety and Feasibility of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Liver Cancer
A Early Phase 1 study testing Drug Eluting Bead Transarterial Chemoembolization and Nivolumab in people with Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites in United States.
Trial summary
The purpose of the study is to find out the effects of using nivolumab with Drug Eluting Bead Transarterial Chemoembolization (deb-TACE) in the treatment of liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Drug Eluting Bead Transarterial Chemoembolization and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 9 sitesUnited States
- Study dates
- 28 Apr 2017to 3 Aug 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Age 18 and over at the time of consent
- Histology and/or cytology confirmed HCC per the enrolling institution. Subjects in Cohort 1 are permitted to enroll w ithout confirmation of HCC as long as imaging LiRADs criteria are met and a biopsy is scheduled prior to or the day of the deb-TACE procedure. HCC confirmation must be completed prior to initiation of nivolumab for all cohorts. If a patient is found to not have confirmed HCC, they w ill be removed from the study.
- Measurable disease per RECIST v1.1
- Disease not amenable to curative or transplant surgery (BCLC Stage B); disease must be reviewed by members of disease management team at the local enrolling institution and be amenable to deb-TACE. For the dose escalation and the expansion, regional lymphadenopathy and sub-centimeter pulmonary nodules are allowed as well as segmental portal vein involvement.
- ECOG Performance status 0 or 1
- Child-Pugh Class A
Show all 17Show fewer
- Child-Pugh Scoring Note: PI INR <1.7 is not required for patients on anticoagulation agents. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists
- Adequate bone marrow, hepatic, and renal function defined as:
- Platelet count ≥ 75,000/mm3
- Absolute neutrophil count ≥ 1,000/mm3
- Hemoglobin ≥ 9 g/dL
- Total bilirubin < 3.0 × ULN (upper limit of normal)
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 5 × ULN
- Albumin ≥ 2.8 g/dL
- Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 40 mL/min as determined by the Cockcroft-Gault equation
- Suppression of HBV (≤ 100 IU/mL by HBV PCR) with antivirals per the local standard of care if prior or current HBV exposure or infection.
- Active HCV infection without treatment is permitted. Concomitant treatment of HCV is not permitted on this study.
Who cannot join
- Vascular invasion or extrahepatic spread
- History of liver allograft; prior hepatic resection is allowed.
- Prior embolization and/or ablation is allowed as long as the patient has progressed with a new RECIST measurable lesion
- Contraindication to angiography/embolization procedure based on judgment of the treating investigator.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Show all 17Show fewer
- A history of a severe contrast allergy (.i.e. anaphylaxis) not controlled with premedication
- Patients should be excluded if they have a condition requiring chronic systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients with contrast allergies who can tolerate contrast with corticosteroid premedication are not excluded.
- An active, known or suspected autoimmune disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
- Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present that in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
- Women of childbearing potential (WOCBP) or sexually active men must use appropriate method(s) of contraception.
- Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception while on study treatment. WOCBP should use an adequate method to avoid pregnancy during study treatment and for 5 months (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception during study treatment and for a period of 7 months after the last dose of investigational product
- Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile, as well as azoospermic men do not require contraception
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab. Elevated HCG for other explained and documented reasons is allowed.
- Lactating woman
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Cancer Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104-4283
Washington University School of Medicine
St Louis, Missouri, 63110
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Multicenter Pilot Study of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma
The purpose of the study is to find out the effects of using nivolumab with Drug Eluting Bead Transarterial Chemoembolization (deb-TACE) in the treatment of liver cancer.
- Conditions
- Liver Cancer
- Being tested
- Drug Eluting Bead Transarterial Chemoembolization, Nivolumab
- Keywords
- nivolumab, deb-TACE, 17-087
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Eluting Bead Transarterial ChemoembolizationDrug
Also called deb-TACE
Hepatic embolization will occur on Day 0 of the study for all cohorts. On the day of the procedure, baseline angiography including celiac and superior mesenteric angiography will be performed to delineate arterial anatomy and blood supply to the tumor. After the entire dose has been used, the embolized vessels will be re-catheterized and embolized to stasis with Bead Block beginning with 100-300 micron spheres and using a maximum of 10 cc of any given size per vessel before moving to the next size microsphere.
NivolumabDrug
All participants will receive at a flat dose of 240 mg IV q 12 weeks for up to one year. In cohort 1, participants will begin nivolumab two weeks (+/- 5 days) after deb-TACE every two weeks. In cohort 2, participants will begin nivolumab every 2 weeks for 1 year and undergo deb-TACE 4 weeks after the initiation of nivolumab (+/- 5 day). Nivolumab will not be dosed on the day of embolization in this cohort. In cohort 3, nivolumab will be dosed every two weeks starting 4 weeks (+/- 5 days) prior to deb-TACE and continue every 2 weeks for up to one year. Nivolumab will be dosed on the day of embolization in this cohort. It will be administered before the deb-TACE procedure.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, deb-TACE + Nivolumab | Experimental | 3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Two weeks after deb-TACE, participants will begin nivolumab every two weeks for up to one year. If no participants experience a dose limiting toxicity (DLT), or 1 of 6 participants experiences a DLT, a new group of participants will be enrolled into Cohort 2. Receives: Drug: Drug Eluting Bead Transarterial Chemoembolization; Drug: Nivolumab |
| Cohort 2, deb-TACE + Nivolumab | Experimental | 3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Participants will receive nivolumab every two weeks for up to one year, starting 4 weeks prior to deb-TACE (week -4). Participants in this cohort will not receive nivolumab on the day of deb-TACE. If no participants experience a DLT in the initial group of 3 participants or if 1 of 6 participants experiences a DLT, a new group of participants will be enrolled into Cohort 3. Receives: Drug: Drug Eluting Bead Transarterial Chemoembolization; Drug: Nivolumab |
| Cohort 3, deb-TACE + Nivolumab | Experimental | 3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Nivolumab will be dosed every two weeks starting 4 weeks prior to deb-TACE (Week 4) and continue every 2 weeks for up to one year. If no participants experience a DLT in the initial group of 3 participants, an additional 3 participants will be added to confirm safety. If less than or equal to 1 of 6 participants experiences a DLT, this will be considered the optimal schedule. Receives: Drug: Drug Eluting Bead Transarterial Chemoembolization; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The percentage of subjects who experience toxicity at each schedule will be calculated. Frequencies of toxicities will be tabulated according to the NCI CTCAE scale (version 4.03).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start28 Apr 2017
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- James Harding, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143270
- Sponsor's protocol ID
- 17-087
- Status last verified
- Aug 2026
- First submitted
- 1 May 2017
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Pilot Study of Nivolumab With Drug Eluting Bead Transarterial Chemoembolization in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03143270
- Acronym / sponsor ID
- 17-087
- Conditions
- Liver Cancer
- Keywords
- nivolumab, deb-TACE, 17-087
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 8 May 2017 (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.
The purpose of the study is to find out the effects of using nivolumab with Drug Eluting Bead Transarterial Chemoembolization (deb-TACE) in the treatment of liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, deb-TACE + Nivolumab | Experimental | Drug: Drug Eluting Bead Transarterial Chemoembolization, Drug: Nivolumab3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Two weeks after deb-TACE, participants will begin nivolumab every two weeks for up to one year. If no participants experience a dose limiting toxicity (DLT), or 1 of 6 participants experiences a DLT, a new group of participants will be enrolled into Cohort 2. |
| Cohort 2, deb-TACE + Nivolumab | Experimental | Drug: Drug Eluting Bead Transarterial Chemoembolization, Drug: Nivolumab3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Participants will receive nivolumab every two weeks for up to one year, starting 4 weeks prior to deb-TACE (week -4). Participants in this cohort will not receive nivolumab on the day of deb-TACE. If no participants experience a DLT in the initial group of 3 participants or if 1 of 6 participants experiences a DLT, a new group of participants will be enrolled into Cohort 3. |
| Cohort 3, deb-TACE + Nivolumab | Experimental | Drug: Drug Eluting Bead Transarterial Chemoembolization, Drug: Nivolumab3 eligible participants will undergo deb-TACE on Day 0 (+/- 5 days). Nivolumab will be dosed every two weeks starting 4 weeks prior to deb-TACE (Week 4) and continue every 2 weeks for up to one year. If no participants experience a DLT in the initial group of 3 participants, an additional 3 participants will be added to confirm safety. If less than or equal to 1 of 6 participants experiences a DLT, this will be considered the optimal schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 18 and over at the time of consent
- Histology and/or cytology confirmed HCC per the enrolling institution. Subjects in Cohort 1 are permitted to enroll w ithout confirmation of HCC as long as imaging LiRADs criteria are met and a biopsy is scheduled prior to or the day of the deb-TACE procedure. HCC confirmation must be completed prior to initiation of nivolumab for all cohorts. If a patient is found to not have confirmed HCC, they w ill be removed from the study.
- Measurable disease per RECIST v1.1
- Disease not amenable to curative or transplant surgery (BCLC Stage B); disease must be reviewed by members of disease management team at the local enrolling institution and be amenable to deb-TACE. For the dose escalation and the expansion, regional lymphadenopathy and sub-centimeter pulmonary nodules are allowed as well as segmental portal vein involvement.
- ECOG Performance status 0 or 1
Key exclusion criteria (17 listed)
- Vascular invasion or extrahepatic spread
- History of liver allograft; prior hepatic resection is allowed.
- Prior embolization and/or ablation is allowed as long as the patient has progressed with a new RECIST measurable lesion
- Contraindication to angiography/embolization procedure based on judgment of the treating investigator.
- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
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 |
|---|---|---|
| Drug Eluting Bead Transarterial ChemoembolizationAlso: deb-TACEHepatic embolization will occur on Day 0 of the study for all cohorts. On the day of the procedure, baseline angiography including celiac and superior mesenteric angiography will be performed to delineate arterial anatomy and blood supply to the tumor. After the entire dose has been used, the embolized vessels will be re-catheterized and embolized to stasis with Bead Block beginning with 100-300 micron spheres and using a maximum of 10 cc of any given size per vessel before moving to the next size microsphere. | Drug | Cohort 1, deb-TACE + Nivolumab, Cohort 2, deb-TACE + Nivolumab, Cohort 3, deb-TACE + Nivolumab |
| NivolumabAll participants will receive at a flat dose of 240 mg IV q 12 weeks for up to one year. In cohort 1, participants will begin nivolumab two weeks (+/- 5 days) after deb-TACE every two weeks. In cohort 2, participants will begin nivolumab every 2 weeks for 1 year and undergo deb-TACE 4 weeks after the initiation of nivolumab (+/- 5 day). Nivolumab will not be dosed on the day of embolization in this cohort. In cohort 3, nivolumab will be dosed every two weeks starting 4 weeks (+/- 5 days) prior to deb-TACE and continue every 2 weeks for up to one year. Nivolumab will be dosed on the day of embolization in this cohort. It will be administered before the deb-TACE procedure. | Drug | Cohort 1, deb-TACE + Nivolumab, Cohort 2, deb-TACE + Nivolumab, Cohort 3, deb-TACE + Nivolumab |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 12 months
The percentage of subjects who experience toxicity at each schedule will be calculated. Frequencies of toxicities will be tabulated according to the NCI CTCAE scale (version 4.03).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
James Harding, MD principal investigator
Memorial Sloan Kettering Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Drug Eluting Bead Transarterial Chemoembolization and Nivolumab in people with Liver Cancer, run by Memorial Sloan Kettering Cancer Center at 9 sites 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 17 inclusion and 17 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 12 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 4 Aug 2026.