AzTrials
AzTrials

Hepatocellular CarcinomaPhase 2NCT04050462

Nivolumab Combined With BMS-986253 in HCC Patients

A Phase 2 study testing Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks, Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks and Nivolumab 240 mg IV every 2 weeks in people with Hepatocellular Carcinoma, run by NYU Langone Health at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

A phase II clinical trial is utilized to examine whether BMS-986253 (25 subjects) or Cabiralizumab (25 subjects) when combined with Nivolumab offers improved radiographic objective response rates (ORR) over Nivolumab monotherapy (25 subjects) in advanced HCC patients. 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?
Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks, Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks and Nivolumab 240 mg IV every 2 weeks
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesUnited States
Study dates
12 Sep 2019to 31 Jan 2025
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

  • Have histologically confirmed evidence of HCC, Childs-Pugh score of ≤7.
  • Participants must be willing to provide specimen from fresh, pre- and on-treatment tumor core biopsies for histologic diagnosis and translational studies.
  • Radiographically measurable disease by RECIST1.1 in at least one site.
  • Deemed to not be a candidate for resection or other local-regional therapy.
  • Must not be receiving treatment with other investigational agents and must not have received any other systemic therapy prior to registration.
  • Prior radioembolization, local ablative therapies (radiofrequency, microwave or cryoablation), radiation (external beam or stereotactic), or hepatic resection permitted if completed ≥ 4 weeks prior to study enrollment and if patient has recovered with ≤ grade 1 toxicity and if untreated measurable disease is present.
Show all 20Show fewer
  • Be willing and able to provide written informed consent/assent for the trial.
  • Participants must be ≥ 18 years
  • Have a Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • If hepatitis B is present, participants must be on anti-viral HBV therapy.
  • All women of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a blood test to rule out pregnancy within 24 hours prior to start of study treatment
  • All women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment (s) and for 5 months following discontinuation of study treatment.
  • Males who are sexually active with women of childbearing potential must agree to follow instructions for method (s) of contraception for the duration of treatment with study treatment and for 7 months following discontinuation of study treatment. Additionally, male participants must not donate sperm during this period.
  • Demonstrate adequate organ function as defined by the following required lab and acceptable range criteria:
  • Adequate bone marrow function:
  • Absolute neutrophil count > 1000/mcL Platelet count > 50,000/mcL Hemoglobin > 8.5 g/dL
  • Adequate hepatic function:
  • Total bilirubin < 2 mg/dL or < 1.5 times upper limit of normal (ULN) AST and ALT < 5 times ULN INR < 1.5 times ULN Albumin > 2.8 g/dL
  • Adequate renal function:
  • Creatinine < 2.0 mg/Dl

Who cannot join

  • Women who are pregnant or breastfeeding.
  • Presence of other malignancies. Participants with active second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ. NOTE: Patients with history of malignancy are not considered to have a "currently active" malignancy if they have completed therapy and are now considered by their physician to be at less than 30% risk for relapse.
  • Have active or history of Tuberculosis
  • Participants with known HIV positive status
  • Participants with known CNS metastases
  • Uncontrolled ascites
Show all 27Show fewer
  • Uncontrolled encephalopathy
  • Uncontrolled gastro-esophageal varicesPrior organ allograft or allogeneic bone marrow transplantation
  • Participants with active, known, or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration except for adrenal replacement steroid doses > 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: Treatment with a short course of steroids (< 5 days) up to 7 days prior to initiating study treatment is permitted.
  • Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity.
  • Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
  • Myocardial infarction or stroke/transient ischemic attack within the past 6 months
  • Uncontrolled angina within the past 3 months
  • Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
  • History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III to IV, pericarditis, significant pericardial effusion, or myocarditis)
  • Cardiovascular disease-related requirement for daily supplemental oxygen therapy.
  • Participants with ongoing or active, uncontrolled infections (afebrile for ≥ 48 hours off antibiotics). If hepatitis B is present, must be on anti-viral HBV therapy.
  • Must not have a psychiatric illness, other significant medical illness, or social situation which, in the investigator's opinion, would limit compliance or ability to comply with study requirements.
  • Any major surgery within 4 weeks of study treatment. Participants must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before
  • Any uncontrolled inflammatory disease including Crohn's disease and ulcerative colitis
  • Treatment with botanical preparations (eg, herbal supplements, including potential drugs of abuse, or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment.
  • Concomitant use of statins while on study.
  • Current or history of clinically significant muscle disorders (eg, myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
  • Known history of sensitivity to infusions containing Tween 20 (polysorbate 20) and Tween 80 (polysorbate 80).
  • Participants who have received a live / attenuated vaccine within 30 days of first treatment.
  • Concomitant use of any live / attenuated vaccine during treatment and until 100 days following last dose.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • NYU Langone Health

    New York, New York, 10016

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: A Phase II, Randomized, Controlled Trial of Nivolumab in Combination With BMS-986253 in Advanced Hepatocellular Carcinoma (HCC) Patients

A phase II clinical trial is utilized to examine whether BMS-986253 (25 subjects) or Cabiralizumab (25 subjects) when combined with Nivolumab offers improved radiographic objective response rates (ORR) over Nivolumab monotherapy (25 subjects) in advanced HCC patients.

Being tested
Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks, Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks, Nivolumab 240 mg IV every 2 weeks
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeksDrug

    Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy

  • Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeksDrug

    Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks

  • Nivolumab 240 mg IV every 2 weeksDrug

    Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy

Study groups in NCT04050462
Study groupRoleWhat they receive
Nivolumab MonotherapyActive comparatorNot described
Receives: Drug: Nivolumab 240 mg IV every 2 weeks
Nivolumab/BMS-986253 combinationExperimentalNot described
Receives: Drug: Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks; Drug: Nivolumab 240 mg IV every 2 weeks
Nivolumab/Cabiralizumab combinationExperimentalNot described
Receives: Drug: Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks; Drug: Nivolumab 240 mg IV every 2 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    ORR is measured as the percentage of people in a study or treatment group who have a partial response or complete response to the treatment. ORR will be determined based upon RECIST v. 1.1 criteria. Per RECIST v. 1.1 criteria, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesions, compared to the baseline.

    Measured: Every 8 weeks for 1 year and every 3 months thereafter (assessed up to 5 years)

Secondary outcomes (4)

  1. Time to Response (TTR)

    TTR is the amount of time it takes for a tumor to show a measurable decrease in size or other signs of response after treatment begins

    Measured: From treatment initiation until first sign of response (up to 5 years)

  2. Disease Control Rate (DOR)

    DOR is the percentage of patients who experience either a complete response (CR), a partial response (PR), or stable disease (SD) to a treatment

    Measured: Through study completion (assessed up to 5 years)

  3. Progression Free Survival (PFS)

    PFS is measured as the time from the date of enrollment to disease progression per RECIST v. 1.1 criteria.

    Measured: From date of treatment until the date of first documented progression (assessed up to 5 years)

  4. Overall Survival (OS)

    OS is the time from treatment start to death of participants.

    Measured: From date of treatment until the date of death from any cause (assessed up to 5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start12 Sep 2019
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Why it stopped: Study was terminated early by the drug sponsor due to slow accrual and a change in the company's drug development priorities

Resources

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
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050462
Sponsor's protocol ID
18-01028
Status last verified
Sep 2025
First submitted
7 Aug 2019
Last updated
16 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks, Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks and Nivolumab 240 mg IV every 2 weeks in people with Hepatocellular Carcinoma, run by NYU Langone Health at 2 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 20 inclusion and 27 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: stopped early, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

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 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Every 8 weeks for 1 year and every 3 months thereafter (assessed up to 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 NCT04050462.

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 16 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in