AzTrials
AzTrials

Metastatic Malignant Neoplasm in the LiverPhase 2NCT03472586

Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver

A Phase 2 study testing Ipilimumab, Nivolumab and Embolization Therapy in people with Metastatic Malignant Neoplasm in the Liver and Metastatic Uveal Melanoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This phase II trial studies ipilimumab and nivolumab with immunoembolization in treating patients with uveal melanoma that has spread to the liver. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ipilimumab, Nivolumab and Embolization Therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteUnited States
Study dates
2 May 2018to 31 Dec 2024
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

  • Histologically confirmed metastatic uveal melanoma in the liver; patients must have at least one measurable liver metastasis that is >= 10 mm in longest diameter by computed tomography (CT) scan or magnetic resonance imaging (MRI)
  • The total volume of the tumors must be less than 50% of the liver volume
  • Willingness and ability to give informed consent
  • Agreement to access archival tissue or agreement for tumor biopsy prior to treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
  • Serum creatinine =< 2.0 mg/dl
Show all 15Show fewer
  • Granulocyte count >= 1000/mm^3
  • Platelet count >= 100,000/mm^3
  • Bilirubin =< 2.0 mg/ml
  • Albumin >= 3.0 g/dl
  • Prothrombin time (PT)/partial thromboplastin time (PTT) less than 1.5 times normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 x upper limit of normal (ULN)
  • Alkaline phosphatase less than 1.5 times ULN (grade 1)
  • Women must not be pregnant or breast-feeding
  • Women of child-bearing potential must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 23 weeks after the last dose of nivolumab and/or ipilimumab and sexually active males must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 31 weeks after the last dose of nivolumab and/or ipilimumab

Who cannot join

  • Failure to meet any of the criteria set forth in the inclusion criteria section
  • Previous systemic exposure to anti-CTLA-4 antibody or anti-PD1 antibody
  • Previous liver-directed treatments including chemoembolization, radiosphere, hepatic arterial perfusion, or drug-eluting beads; liver resection and focal ablation are permitted
  • Presence of symptomatic liver failure including ascites and hepatic encephalopathy
  • Presence of untreated brain metastases; if patients have had previous treatment for the brain metastasis, an MRI or CT scan of the brain must confirm the stabilization of the brain metastasis for more than 2 months
  • Presence of uncontrolled hypertension or congestive heart failure, or acute myocardial infarction within 6 months of entry
Show all 17Show fewer
  • Presence of any other medical complication that implies survival of less than six months
  • Uncontrolled severe bleeding tendency or active gastrointestinal (GI) bleeding
  • Significant allergic reaction to contrast dye or granulocyte-macrophage colony-stimulating (GM-CSF)
  • Immunosuppressive treatments within 4 weeks prior to embolization, unless prednisone =< 5 mg or equivalent
  • Pregnancy or breast-feeding women
  • Patients with active hepatitis with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) equal or greater than 5 times normal
  • Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
  • Positive for known human immunodeficiency virus (HIV) Infection
  • Uncontrolled chronic obstructive pulmonary disease or previous known pulmonary fibrosis
  • Active infection
  • Auto-immune disease including inflammatory bowel disease, lupus, rheumatoid arthritis, but not including hypothyroidism or psoriasis if condition has been stable for 2 months or greater

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Ipilimumab and Nivolumab in Combination With Immunoembolization for the Treatment of Metastatic Uveal Melanoma

This phase II trial studies ipilimumab and nivolumab with immunoembolization in treating patients with uveal melanoma that has spread to the liver. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunoembolization may kill tumor cells due to loss of blood supply and develop an immune response against tumor cells. Giving ipilimumab and nivolumab with immunoembolization may work better in treating patients with uveal melanoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the clinical benefit of treatment with immunoembolization (IEMBO) in combination with ipilimumab and nivolumab.

SECONDARY OBJECTIVES:

  1. Determine all treatment and immune related toxicities. II. Determine progression free survival. III. Determine overall survival.
Being tested
Ipilimumab, Nivolumab, Embolization Therapy
Medical subject headings
Uveal Melanoma

What participants receive

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

  • IpilimumabBiological

    Also called Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, 720801

    Given IV

  • NivolumabBiological

    Also called 946414-94-4, BMS-936558, ONO-4538, Opdivo

    Given IV

  • Embolization TherapyDrug

    Undergo immunoembolization

Study groups in NCT03472586
Study groupRoleWhat they receive
Treatment (ipilimumab, nivolumab, immunoembolization)ExperimentalPatients receive ipilimumab IV over 30 minutes and nivolumab IV over 30 minutes on day 1. Patients also undergo immunoembolization on day 2. Cycles repeat every 3 weeks for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease may receive nivolumab IV on day 1 and undergo immunoembolization on day 2. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. The interval between treatments may be extended up to every 6 weeks at the discretion of the treating physician.
Receives: Biological: Ipilimumab; Biological: Nivolumab; Drug: Embolization Therapy

What is being measured

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

  1. Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)

    Defined as complete response + partial response + stable disease. Rated by Response Evaluation Criteria in Solid Tumors version 1.1. The estimate of the hepatic metastasis stabilization rate will be presented with corresponding 95% confidence intervals. The method of Atkinson and Brown will be used to adjust for the two-stage design.

    Measured: At the end of 4th treatment cycle (Day 84 +/- 3 days). Cycles are 21 days.

Secondary outcomes (3)

  1. Number of Participants With Adverse Events

    Graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity rates will be estimated with corresponding 95% confidence intervals.

    Measured: Up to 1 year

  2. Progression Free Survival (PFS)

    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Will be estimated using the Kaplan-Meier method.

    Measured: From the start of the treatment to confirmation of progression of disease, assessed up to 1 year

  3. Overall Survival

    Will be estimated using the Kaplan-Meier method.

    Measured: 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 posted21 Mar 2018
  2. Study start2 May 2018
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2024

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
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03472586
Sponsor's protocol ID
18P.042
Other IDs
JT 10364
Status last verified
Jun 2026
First submitted
14 Mar 2018
Last updated
7 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ipilimumab, Nivolumab and Embolization Therapy in people with Metastatic Malignant Neoplasm in the Liver and Metastatic Uveal Melanoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 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 7 Jul 2026. 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 29 Nov 2023). 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?

Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) (time frame: At the end of 4th treatment cycle (Day 84 +/- 3 days). Cycles are 21 days.). 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 NCT03472586.

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 7 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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