Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-24 @ 5:35 PM
NCT ID:
NCT04463368
Eligibility Criteria:
Inclusion Criteria
1. Patient is ≥18 years of age on the day of signing informed consent
2. Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures
3. Patient must have a histologically confirmed diagnosis of stage IV uveal melanoma. If tissue biopsy is judged not feasible by the investigator, cytological diagnosis from fine needle aspiration (FNA) will be accepted
4. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria with at least one target lesion identified in the liver.
5. ECOG performance status of 0 or 1
6. No previous immunotherapy for uveal melanoma metastases.
7. Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
8. Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
9. Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
Exclusion Criteria
1. Life expectancy of less than 3 months
2. Body mass index above 35
3. More than 50% of the liver volume replaced by tumor as measured by CT or MRI
4. Known congestive heart failure with an LVEF \<40%
5. COPD or other chronic pulmonary disease with PFT's indicating an FEV\< 50% predicted for age
6. Interstitial lung disease (ILD) or (non-infectious) pneumonitis
7. Reduced renal function defined as S-Creatinine \>=1.5xULN or Creatinine Clearance \< 40 mL/min, calculated using the Cockroft and Gault formula
8. Reduced hepatic function (defined as AST, ALT, bilirubin\>3\*ULN and PK-INR\>1.5) or medical history of liver cirrhosis or portal hypertension
9. Hemoglobin \<90 g/L or platelets \<100x109/L or neutrophils \<1.5x109/L
10. Use of live vaccines four weeks before or after the last study treatment
11. History of severe hypersensitivity reactions to mAbs
12. Known human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C
13. Active autoimmune disease or a history of known or suspected autoimmune disease
14. A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
15. Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs
16. Has a known additional malignancy that is progressing or requires active treatment.
17. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.
18. A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04463368
Study Brief:
Protocol Section:
NCT04463368