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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-02

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Trial of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated Metastatic Uveal Melanoma

NCT02626962

Uveal Melanoma

COMPLETED PHASE2

Radioembolization and Ipilimumab in Treating Patients With Uveal Melanoma With Liver Metastases

NCT01730157

Ciliary Body and Choroid Melanoma, Medium/Large Size Ciliary Body and Choroid Melanoma, Small Size Extraocular Extension Melanoma +5 more

TERMINATED EARLY_PHASE1

An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma

NCT03068455

Melanoma

COMPLETED PHASE3

PHP and Immunotherapy in Metastasized UM

NCT04283890

Uveal Melanoma, Metastatic

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Study of Adjuvant Ipilimumab and Nivolumab in Subjects With High-risk Ocular Melanoma

NCT03528408

Melanoma Ocular Melanoma

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. Determine all treatment and immune related toxicities. II. Determine progression free survival. III. Determine overall survival.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Malignant Neoplasm in the Liver Metastatic Uveal Melanoma Stage IV Uveal Melanoma AJCC v7

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment (ipilimumab, nivolumab, immunoembolization)

Patients 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.

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type BIOLOGICAL

Given IV

Nivolumab

Intervention Type BIOLOGICAL

Given IV

Embolization Therapy

Intervention Type DRUG

Undergo immunoembolization

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ipilimumab

Given IV

Intervention Type BIOLOGICAL

Nivolumab

Given IV

Intervention Type BIOLOGICAL

Embolization Therapy

Undergo immunoembolization

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody BMS-734016 MDX-010 720801 477202-00-9 732442 946414-94-4 BMS-936558 ONO-4538 Opdivo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* 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

* 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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No