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Hepatocellular CarcinomaPhase 2NCT03781960

Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma

A Phase 2 study testing Abemaciclib and Nivolumab in people with Hepatocellular Carcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Terminated

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

Official record
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Trial summary

The main purpose of this study is to evaluate the effectiveness of the combination of nivolumab and abemaciclib for the treatment of hepatocellular carcinoma. Other goals of this study are to learn about the side effects that this combination of drugs may cause and to learn more about how these drugs work by studying… 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?
Abemaciclib and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
31 Jul 2019to 29 Apr 2022
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

  • Subjects must have hepatocellular carcinoma (HCC) that is inoperable (where surgery is not indicated due to disease extent, co-morbidities, or other technical reasons)
  • Histologic confirmation of HCC is not required for screening but is required prior to initiation of study treatment. Subjects with hepatocholangiocarcinoma or cholangiocarcinoma are not eligible.
  • Tumor must be positive for retinoblastoma (RB) expression by immunohistochemistry
  • Age > 18 years and ability to understand and the willingness to sign a written informed consent document.
  • ECOG performance status of 0 or 1
  • Childs-Pugh score of <7
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  • Life expectancy of at least 12 weeks
  • Must be able to swallow tablets
  • Must be willing to comply with protocol procedures (including completion of diaries and outcome measures)
  • Local or loco-regional therapy to the liver (i.e. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed > 4 weeks prior to enrollment
  • Must be willing to undergo a pretreatment and on-treatment biopsy and have a tumor site that is accessible for core needle biopsy
  • Measurable or evaluable disease as defined by RECIST v. 1.1
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days of the first dose of abemaciclib (see Appendix A for definition of childbearing potential). Female subjects of childbearing potential must use an approved contraceptive method (detailed in Appendix A) for the duration of the study and an additional 3 weeks after the final dose of abemaciclib.
  • Subjects with hepatitis B must have an HBV viral load < 100 IU/mL by PCR during screening
  • Must have adequate organ and hematopoietic function as defined below:

Who cannot join

  • Any history of a serious medical or psychiatric condition that would prevent the subject from signing the informed consent form
  • Pregnant or breastfeeding
  • Use of any chemotherapy within 3 weeks prior to the first study treatment date
  • Use of any experimental therapy within 4 weeks or 5 half-lives, whichever is longer, prior to the first study treatment date
  • Use of radiation within 2 weeks prior to the first study treatment date (4 weeks if radiation to liver as per section 4.1)
  • Prior treatment with a CDK 4/6 inhibitor
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  • Prior treatment with a PD-1 or PD-L1 inhibitor
  • Those who have not recovered from adverse events < Grade 1 from prior therapy, with the exceptions of alopecia of any grade or stable peripheral neuropathy < Grade 2
  • Subjects may not receive concomitant anticancer agents or radiation. Antiviral agents aimed at treating infectious hepatitis are permitted
  • History of or suspected hypersensitivity to nivolumab or abemaciclib
  • Uncontrolled ascites
  • Esophageal varices requiring treatment within the past 6 months (banding or medication)
  • Subjects with uncontrolled brain metastases. Subjects with brain metastases must have stable neurological status following local therapy (surgery or radiation) for at least 4 weeks prior to first study treatment and must be off of steroids related to the brain metastases.
  • Any concurrent condition requiring the continued or anticipated use of systemic steroids beyond physiologic replacement dosing (excluding non-systemic inhaled, topical skin, nasal, and/or ophthalmic corticosteroids). All other systemic corticosteroids above physiologic replacement dosing must be discontinued at least 4 weeks prior to first study treatment
  • Active drug or alcohol use or dependence as documented in the chart that, in the opinion of the investigator, would interfere with adherence to study requirements
  • Active bacterial or fungal infection requiring IV therapy at the start of protocol treatment
  • A second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results
  • Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)
  • Personal history of ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
  • Prior organ allograft or allogeneic bone marrow transplantation
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
  • Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the Principal Investigator
  • Any other conditions judged by the investigator that would limit the evaluation of the subject
  • HIV positive by PCR

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase II Trial of Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma

The main purpose of this study is to evaluate the effectiveness of the combination of nivolumab and abemaciclib for the treatment of hepatocellular carcinoma. Other goals of this study are to learn about the side effects that this combination of drugs may cause and to learn more about how these drugs work by studying blood and tissue.

Being tested
Abemaciclib, Nivolumab
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • AbemaciclibDrug

    Also called Verzenio

    Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.

  • NivolumabDrug

    Also called Opdivo

    Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.

Study groups in NCT03781960
Study groupRoleWhat they receive
Abemaciclib & NivolumabExperimentalSubjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Receives: Drug: Abemaciclib; Drug: Nivolumab

What is being measured

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

  1. Objective Response Rate

    The objective response rate is determined by the percentage of participants on study attaining a partial or complete response as noted per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: up to 2 years

Secondary outcomes (3)

  1. Progression-Free Survival

    Progression-Free survival is determined from the start of study treatment until the time of documented disease progression or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) and iRECIST criteria (guidelines for response criteria for use in trials testing immunotherapies)

    Measured: From the start of study treatment until disease progression, death, whichever came first up to 2 years

  2. Duration of Response

    Time from the first recorded partial response or complete response (whichever comes first) defined Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; until disease progression or death

    Measured: up to 2 years

  3. Overall Survival

    Measured: From the start of treatment to death, due to any cause or last patient contact alive, assessed up to 2 years

Timeline

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

  1. First posted20 Dec 2018
  2. Study start31 Jul 2019
  3. Primary completion29 Apr 2022
  4. Study completion29 Apr 2022

Why it stopped: Safety letter from sponsor

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03781960
Sponsor's protocol ID
UPCC 35218
Status last verified
Nov 2022
First submitted
17 Dec 2018
Last updated
14 Dec 2022
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abemaciclib and Nivolumab in people with Hepatocellular Carcinoma, run by Abramson Cancer Center at Penn Medicine 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 15 inclusion and 24 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 14 Dec 2022. 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 14 Dec 2022). 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 (time frame: up to 2 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 NCT03781960.

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 14 Dec 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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