A Phase 2 interventional study of Ipilimumab and Nivolumab in Metastatic Malignant Neoplasm in the Liver, Metastatic Uveal Melanoma and Stage IV Uveal Melanoma AJCC v7, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 17 studies testing ipilimumab in Uveal Melanoma — 1 open to participants now, 3 under way, none of them phase 3. Ipilimumab · Uveal Melanoma.
Among the 17 studies testing ipilimumab in Uveal Melanoma, this one is the 12th largest by enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2018, is one of 8 in phase 2, and was the 11th registered.
281 studies on the registry are indexed under Uveal Melanoma; 50 are open to participants now.
Browse Uveal Melanoma studies →1 of the 17 studies testing ipilimumab in Uveal Melanoma is open now, in 1 country. Recruiting first, the newest first:
Inge Marie Svane · Sites in Denmark
Ages 18–80
By country, each count listing its studies:
Ipilimumab: first FDA approval 2011 (YERVOY), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 42 Uveal Melanoma studies recruiting now, 35 (83%) set no upper age limit and 4 (10%) stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, ipilimumab is the treatment under test here. Read study by study →
17 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 11
First in 2001; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 14 is below the median of 37 across 222 interventional studies indexed under Uveal Melanoma.
Median enrollment 24 across the 15 interventional studies. Of the 13 that completed or were terminated, 4 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 17 have an industry lead sponsor. The 10 most frequent:
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University is the lead sponsor of 41 studies on the registry; 3 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 14 (82%) have results posted.
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University has 3 studies filed under Uveal Melanoma — fewer than ten, so there is no comparison to draw.
1 of the studies testing ipilimumab in Uveal Melanoma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04283890Leiden University Medical CenterPHP and Immunotherapy in Metastasized UM | 2026-12 |
Add it to your calendar (.ics) → With an account.
Among the 17 studies testing ipilimumab in Uveal Melanoma, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Ipilimumab · Biological: Nivolumab · Drug: Embolization Therapy
Given IV
Also known as: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, 720801, 477202-00-9, 732442
Given IV
Also known as: 946414-94-4, BMS-936558, ONO-4538, Opdivo
Undergo immunoembolization
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.
Time frame: At the end of 4th treatment cycle (Day 84 +/- 3 days). Cycles are 21 days.
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.
Time frame: Up to 1 year
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.
Time frame: From the start of the treatment to confirmation of progression of disease, assessed up to 1 year
Overall Survival
Will be estimated using the Kaplan-Meier method.
Time frame: up to 2 years
| Milestone | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| Started | 14 |
| Completed | 1 |
| Not completed | 13 |
| Withdrew: Physician decision | 6 |
| Withdrew: Death | 6 |
| Withdrew: Adverse event | 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.
| Participants | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| Complete response | 0 |
| Partial response | 0 |
| Stable Disease | 8 |
| Progressive disease | 5 |
| Not Evaluated | 1 |
Graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Toxicity rates will be estimated with corresponding 95% confidence intervals.
| Proportion of Participants | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| Number of Participants With Adverse Events | 1.00 (0.77 to 1) |
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.
| months | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| Progression Free Survival (PFS) | 4.53 (2.56 to 6.67) |
Will be estimated using the Kaplan-Meier method.
| months | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| Overall Survival | 21.55 (10.48 to 23.29) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Ipilimumab, Nivolumab, Immunoembolization) | 13/14 (92.9%) | 1/14 (7.1%) | 14/14 (100%) |
| Event | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| grade 3 thromboembolic event that resulted in a hospitalizationVascular disorders | 1/14 |
| hepatic hemorrhage - grade 3Hepatobiliary disorders | 1/14 |
| Dyspnea - Grade 5Respiratory, thoracic and mediastinal disorders | 1/14 |
| DeathRespiratory, thoracic and mediastinal disorders | 1/14 |
| Dyspnea - Grade 3Respiratory, thoracic and mediastinal disorders | 1/14 |
| Paresthesia - Grade 1Vascular disorders | 1/14 |
| Diarrhea - grade 3Gastrointestinal disorders | 1/14 |
| Colitis - grade 3Gastrointestinal disorders | 1/14 |
| Event | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| Pericardial Effusion - Grade 0Cardiac disorders | 14/14 |
| Hyperthyroidism - Grade 0Endocrine disorders | 14/14 |
| Hypothyroidism - Grade 0Endocrine disorders | 14/14 |
| Blurred vision - Grade 0Eye disorders | 14/14 |
| Decreased vision - grade 0Eye disorders | 14/14 |
| Abdominal bloating - Grade 0Gastrointestinal disorders | 14/14 |
| Abdominal distension - Grade 0Gastrointestinal disorders | 14/14 |
| Colitis - Grade 0Gastrointestinal disorders | 14/14 |
| Constipation - Grade 0Gastrointestinal disorders | 14/14 |
| Diarrhea - Grade 0Gastrointestinal disorders | 14/14 |
| Age, Categorical(Participants) | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 5 |
| Sex: Female, Male(Participants) | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| Female | 5 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Ipilimumab, Nivolumab, Immunoembolization) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 12 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Dec 2022, 55 months.
Results were first posted in Nov 2023, 10 months after primary completion.
Of 39 non-industry phase 2 interventional studies under Uveal Melanoma, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 95. This study's 55 months is close to that.
Counting every sponsor, half of 46 studies reached it within 52 months; a quarter within 37 and three quarters within 84.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Ipilimumab · Nivolumab
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University