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| ID | Type | Description | Link |
|---|---|---|---|
| JT 10364 | Other Identifier | JeffTrial Number |
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (ipilimumab, nivolumab, immunoembolization) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipilimumab | Biological | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of 4th treatment cycle (Day 84 +/- 3 days). Cycles are 21 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marlana Orloff, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | View source |
| Thomas Jefferson University Hospital | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Ipilimumab: Given IV Nivolumab: Given IV Embolization Therapy: Undergo immunoembolization |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2020 |
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| Nivolumab | Biological | Given IV |
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| Embolization Therapy | Drug | Undergo immunoembolization |
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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. |
| 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. | up to 2 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Ipilimumab: Given IV Nivolumab: Given IV Embolization Therapy: Undergo immunoembolization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | At the end of 4th treatment cycle (Day 84 +/- 3 days). Cycles are 21 days. |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Proportion of Participants | Up to 1 year |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Median | 95% Confidence Interval | months | From the start of the treatment to confirmation of progression of disease, assessed up to 1 year |
|
| |||||||||||||||||||||||||||||||
| Secondary | Overall Survival | Will be estimated using the Kaplan-Meier method. | Posted | Median | 95% Confidence Interval | months | up to 2 years |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Ipilimumab: Given IV Nivolumab: Given IV Embolization Therapy: Undergo immunoembolization | 13 | 14 | 1 | 14 | 14 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| grade 3 thromboembolic event that resulted in a hospitalization | Vascular disorders | Systematic Assessment |
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| hepatic hemorrhage - grade 3 | Hepatobiliary disorders | Systematic Assessment |
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| Dyspnea - Grade 5 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Death | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnea - Grade 3 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Paresthesia - Grade 1 | Vascular disorders | Systematic Assessment |
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| Diarrhea - grade 3 | Gastrointestinal disorders | Systematic Assessment |
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| Colitis - grade 3 | Gastrointestinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death - disease progression | General disorders | Systematic Assessment |
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| Tachycardia - Grade 1 | Cardiac disorders | Systematic Assessment |
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| Vertigo - Grade 0 | Ear and labyrinth disorders | Systematic Assessment |
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| Chills - 0 | General disorders | Systematic Assessment |
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| Fatigue - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Edema - extremities - grade 0 | General disorders | Systematic Assessment |
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| Pericardial Effusion - Grade 0 | Cardiac disorders | Systematic Assessment |
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| Tachycardia - Grade 0 | Cardiac disorders | Systematic Assessment |
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| Vertigo - Grade 1 | Ear and labyrinth disorders | Systematic Assessment |
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| Hyperthyroidism - Grade 0 | Endocrine disorders | Systematic Assessment |
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| Hypothyroidism - Grade 0 | Endocrine disorders | Systematic Assessment |
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| Blurred vision - Grade 0 | Eye disorders | Systematic Assessment |
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| Decreased vision - grade 0 | Eye disorders | Systematic Assessment |
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| Chills - Grade 1 | General disorders | Systematic Assessment |
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| Chills - Grade 2 | General disorders | Systematic Assessment |
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| Fatigue - Grade 1 | General disorders | Systematic Assessment |
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| Fatigue - Grade 2 | General disorders | Systematic Assessment |
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| Edema - extremities - Grade 1 | General disorders | Systematic Assessment |
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| Fever - Grade 0 | General disorders | Systematic Assessment |
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| Fever - Grade 1 | General disorders | Systematic Assessment |
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| Fever - Grade 2 | General disorders | Systematic Assessment |
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| Flu-like symptoms - Grade 0 | General disorders | Systematic Assessment |
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| Flu-like symptoms - Grade 1 | General disorders | Systematic Assessment |
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| Edema - Localized - Grade 0 | General disorders | Systematic Assessment |
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| Edema - Localized - Grade 1 | General disorders | Systematic Assessment |
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| Non-cardiac chest pain - Grade 0 | General disorders | Systematic Assessment |
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| Non-cardiac chest pain - Grade 1 | General disorders | Systematic Assessment |
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| Pain - Grade 0 | General disorders | Systematic Assessment |
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| Pain - Grade 1 | General disorders | Systematic Assessment |
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| Pain - Grade 2 | General disorders | Systematic Assessment |
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| Pain - Grade 3 | General disorders | Systematic Assessment |
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| Rigors - Grade 0 | General disorders | Systematic Assessment |
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| Rigors - Grade 1 | General disorders | Systematic Assessment |
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| Abdominal bloating - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal distension - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain - grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| Abdominal pain - Grade 3 | Gastrointestinal disorders | Systematic Assessment |
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| Colitis - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Constipation - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Dry Mouth - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Dysphagia - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Dyspepsia - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| Flatulence - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Nausea - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Nausea - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| Nausea - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting - Grade 0 | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting - Grade 1 | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting - Grade 2 | Gastrointestinal disorders | Systematic Assessment |
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| Hepatic Pain - Grade 0 | Hepatobiliary disorders | Systematic Assessment |
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| Hepatic Pain - Grade 2 | Hepatobiliary disorders | Systematic Assessment |
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| ALT increased - Grade 0 | Investigations | Systematic Assessment |
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| ALT increased - Grade 3 | Investigations | Systematic Assessment |
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| ALT increased - Grade 4 | Investigations | Systematic Assessment |
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| AST increased - Grade 0 | Investigations | Systematic Assessment |
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| AST increased - Grade 3 | Investigations | Systematic Assessment |
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| AST increased - Grade 4 | Investigations | Systematic Assessment |
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| Blood bilirubin increased - Grade 0 | Investigations | Systematic Assessment |
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| Blood bilirubin increased - Grade 3 | Investigations | Systematic Assessment |
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| Creatinine increased - Grade 0 | Investigations | Systematic Assessment |
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| Creatinine increased - Grade 1 | Investigations | Systematic Assessment |
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| Creatinine Kinase increased - Grade 0 | Investigations | Systematic Assessment |
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| Troponin Increased - Grade 0 | Investigations | Systematic Assessment |
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| Arthralgia - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain - grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Back pain - Grade 3 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gait disturbance - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Gait disturbance - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Generalized Muscle Weakness - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hand pain - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hand pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hip Pain - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Hip Pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Knee pain - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle cramps - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Muscle cramps - Grade 2 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Myalgia - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck pain - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shoulder pain - Grade 0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Shoulder pain - Grade 1 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Anorexia - Grade 0 | Metabolism and nutrition disorders | Systematic Assessment |
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| Anorexia - Grade 2 | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyperglycemia - Grade 0 | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoalbuminia - Grade 0 | Metabolism and nutrition disorders | Systematic Assessment |
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| Hyponatremia - Grade 0 | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphatemia - Grade 0 | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypophosphatemia - Grade 3 | Metabolism and nutrition disorders | Systematic Assessment |
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| Weight loss - Grade 0 | Metabolism and nutrition disorders | Systematic Assessment |
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| Weight loss - Grade 1 | Metabolism and nutrition disorders | Systematic Assessment |
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| Dizziness - Grade 0 | Nervous system disorders | Systematic Assessment |
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| Dysgeusia - Grade 0 | Nervous system disorders | Systematic Assessment |
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| Dysgeusia - Grade 2 | Nervous system disorders | Systematic Assessment |
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| Headache - Grade 0 | Nervous system disorders | Systematic Assessment |
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| Larynsophageal Dysthesia - Grade 0 | Nervous system disorders | Systematic Assessment |
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| Paresthesia - Grade 0 | Nervous system disorders | Systematic Assessment |
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| Paresthesia - Grade 3 | Nervous system disorders | Systematic Assessment |
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| Peripheral Neuropathy - Grade 0 | Nervous system disorders | Systematic Assessment |
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| Postoperative hemorrhage - Grade 0 | Surgical and medical procedures | Systematic Assessment |
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| Postoperative hemorrhage - Grade 1 | Surgical and medical procedures | Systematic Assessment |
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| Postoperative hemorrhage - Grade 2 | Surgical and medical procedures | Systematic Assessment |
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| Confusion - Grade 0 | Psychiatric disorders | Systematic Assessment |
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| Scrotal edema - Grade 0 | Reproductive system and breast disorders | Systematic Assessment |
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| Urinary incontinence - Grade 0 | Renal and urinary disorders | Systematic Assessment |
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| Cough - Grade 0 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dyspnea - Grade 0 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pleural Effusion - Grade 0 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Erythematous Papule - Grade 0 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain at cath. site - Grade 0 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain at cath. site - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain at cath. site - Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Periorbital Edema - Grade 0 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Periorbital Edema - Grade 1 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus - Grade 0 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash - Maculopapular - Grade 0 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Rash - Pustular - Grade 0 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Skin Ulceration - Grade 0 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Uticaria - Grade 0 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hematoma - Grade 0 | Vascular disorders | Systematic Assessment |
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| Hematoma - Grade 1 | Vascular disorders | Systematic Assessment |
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| Hypotension - Grade 0 | Vascular disorders | Systematic Assessment |
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| Hypotension - Grade 1 | Vascular disorders | Systematic Assessment |
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| Hypotension - Grade 2 | Vascular disorders | Systematic Assessment |
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| Thromboembolic event - Grade 0 | Vascular disorders | Systematic Assessment |
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| Thromboembolic event - Grade 3 | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marlana Orloff, MD | Thomas Jefferson University | 215-955-9974 | marlana.orloff@jefferson.edu |
| Aug 11, 2023 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D009371 | Neoplasms by Site |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| D060908 | CTLA-4 Antigen |
| D000077594 | Nivolumab |
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D000082102 | Immune Checkpoint Proteins |
| D061025 | Costimulatory and Inhibitory T-Cell Receptors |
| D011971 | Receptors, Immunologic |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D000945 | Antigens, Differentiation, T-Lymphocyte |
| D000943 | Antigens, Differentiation |
| D000954 | Antigens, Surface |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D015415 | Biomarkers |
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
Not provided
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Progressive disease |
|
| Not Evaluated |
|
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|
|