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NCT03472586

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

Completed Phase 2 Results posted Last updated 24 April 2025
What this trial tests

Phase 2 trial testing Ipilimumab in Metastatic Malignant Neoplasm in the Liver in 14 participants. Completed in 31 December 2024.

Timeline
2 May 2018
Primary endpoint
31 December 2022
31 December 2024

Quick facts

Lead sponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment14
Start date2 May 2018
Primary completion31 December 2022
Estimated completion31 December 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Who can join

18 and older, any sex, with Metastatic Malignant Neoplasm in the Liver or Metastatic Uveal Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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.

GroupValue95% CI
Treatment (Ipilimumab, Nivolumab, Immunoembolization)0
Treatment (Ipilimumab, Nivolumab, Immunoembolization)0
Treatment (Ipilimumab, Nivolumab, Immunoembolization)8
Treatment (Ipilimumab, Nivolumab, Immunoembolization)5

Adverse events — posted to ClinicalTrials.gov

Time frame: The adverse event reporting period for this trial begins when the patient receives the first treatment and ends 3 months after completion or withdrawal from the study. Treatment period is maximum of 2 years, thus reporting period is maximum of 27 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Ipilimumab, Nivolumab, Immunoembolization)
Serious: 1/14 (7%)
Deaths: 13/14

Serious adverse events (8 terms)

ReactionSystemTreatment (Ipilimumab, Niv…
grade 3 thromboembolic event that resulted in a hospitalizationVascular disorders
hepatic hemorrhage - grade 3Hepatobiliary disorders
Dyspnea - Grade 5Respiratory, thoracic and mediastinal disorders
DeathRespiratory, thoracic and mediastinal disorders
Dyspnea - Grade 3Respiratory, thoracic and mediastinal disorders
Paresthesia - Grade 1Vascular disorders
Diarrhea - grade 3Gastrointestinal disorders
Colitis - grade 3Gastrointestinal disorders
Other adverse events (130 terms — click to expand)

ReactionSystemTreatment (Ipilimumab, Niv…
Pericardial Effusion - Grade 0Cardiac disorders
Hyperthyroidism - Grade 0Endocrine disorders
Hypothyroidism - Grade 0Endocrine disorders
Blurred vision - Grade 0Eye disorders
Decreased vision - grade 0Eye disorders
Abdominal bloating - Grade 0Gastrointestinal disorders
Abdominal distension - Grade 0Gastrointestinal disorders
Colitis - Grade 0Gastrointestinal disorders
Constipation - Grade 0Gastrointestinal disorders
Diarrhea - Grade 0Gastrointestinal disorders
Dry Mouth - Grade 0Gastrointestinal disorders
Dysphagia - Grade 0Gastrointestinal disorders
Flatulence - Grade 0Gastrointestinal disorders
Creatinine Kinase increased - Grade 0Investigations
Troponin Increased - Grade 0Investigations
Arthralgia - Grade 0Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness - Grade 0Musculoskeletal and connective tissue disorders
Knee pain - Grade 0Musculoskeletal and connective tissue disorders
Myalgia - Grade 0Musculoskeletal and connective tissue disorders
Neck pain - Grade 0Musculoskeletal and connective tissue disorders
Hyperglycemia - Grade 0Metabolism and nutrition disorders
Hypoalbuminia - Grade 0Metabolism and nutrition disorders
Hyponatremia - Grade 0Metabolism and nutrition disorders
Dizziness - Grade 0Nervous system disorders
Headache - Grade 0Nervous system disorders
Larynsophageal Dysthesia - Grade 0Nervous system disorders
Peripheral Neuropathy - Grade 0Nervous system disorders
Confusion - Grade 0Psychiatric disorders
Scrotal edema - Grade 0Reproductive system and breast disorders
Urinary incontinence - Grade 0Renal and urinary disorders
Cough - Grade 0Respiratory, thoracic and mediastinal disorders
Dyspnea - Grade 0Respiratory, thoracic and mediastinal disorders
Pleural Effusion - Grade 0Respiratory, thoracic and mediastinal disorders
Erythematous Papule - Grade 0Skin and subcutaneous tissue disorders
Pruritus - Grade 0Skin and subcutaneous tissue disorders
Rash - Maculopapular - Grade 0Skin and subcutaneous tissue disorders
Rash - Pustular - Grade 0Skin and subcutaneous tissue disorders
Skin Ulceration - Grade 0Skin and subcutaneous tissue disorders
Uticaria - Grade 0Skin and subcutaneous tissue disorders
Vertigo - Grade 0Ear and labyrinth disorders

Most-reported serious reactions: grade 3 thromboembolic event that resulted in a hospitalization, hepatic hemorrhage - grade 3, Dyspnea - Grade 5, Death, Dyspnea - Grade 3, Paresthesia - Grade 1, Diarrhea - grade 3, Colitis - grade 3.

Data from ClinicalTrials.gov NCT03472586 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Update on uveal melanoma: Translational research from biology to clinical practice (Review).
    Ortega MA, Fraile-Martínez O, García-Honduvilla N, Coca S, et al · · 2020 · cited 47× · PMID 33173970 · DOI 10.3892/ijo.2020.5140
  2. Immunobiology of Uveal Melanoma: State of the Art and Therapeutic Targets.
    Basile MS, Mazzon E, Fagone P, Longo A, et al · · 2019 · cited 42× · PMID 31750244 · DOI 10.3389/fonc.2019.01145
  3. Recent Advances and Challenges in Uveal Melanoma Immunotherapy.
    Fu Y, Xiao W, Mao Y. · · 2022 · cited 41× · PMID 35804863 · DOI 10.3390/cancers14133094
  4. A Prospective Phase II Trial of Radioembolization for Treatment of Uveal Melanoma Hepatic Metastasis.
    Gonsalves CF, Eschelman DJ, Adamo RD, Anne PR, et al · · 2019 · cited 41× · PMID 31453767 · DOI 10.1148/radiol.2019190199
  5. Current Melanoma Treatments: Where Do We Stand?
    Moreira A, Heinzerling L, Bhardwaj N, Friedlander P. · · 2021 · cited 36× · PMID 33435389 · DOI 10.3390/cancers13020221
  6. Molecular Insights and Emerging Strategies for Treatment of Metastatic Uveal Melanoma.
    Mallone F, Sacchetti M, Lambiase A, Moramarco A. · · 2020 · cited 34× · PMID 32992823 · DOI 10.3390/cancers12102761
  7. An Outcome Assessment of a Single Institution's Longitudinal Experience with Uveal Melanoma Patients with Liver Metastasis.
    Seedor RS, Eschelman DJ, Gonsalves CF, Adamo RD, et al · · 2020 · cited 29× · PMID 31906411 · DOI 10.3390/cancers12010117
  8. Genetic Landscape and Emerging Therapies in Uveal Melanoma.
    Seedor RS, Orloff M, Sato T. · · 2021 · cited 27× · PMID 34771666 · DOI 10.3390/cancers13215503

Verify or expand the search:

Other trials of Ipilimumab

Trials testing the same drug.

Other recruiting trials for Metastatic Malignant Neoplasm in the Liver

Currently open trials in the same condition.

Other Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03472586.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing