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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT01950195
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have histologically confirmed diagnosis of melanoma. The pathologic confirmation may be from another metastatic site or from metastatic brain or spine lesions.
2. Patients must have Stage IV melanoma, with newly identified brain or spine metastases.
3. Patients must have measurable lesion in the brain or spine that is \> 3 mm seen on magnetic resonance imaging (MRI) with contrast.
NOTE: Contrasted pre-treatment MRI scan must be obtained ≤ 21 days prior to stereotactic radiosurgery treatment.
4. Karnofsky Performance Scale \>70%
5. Patients must have normal organ and marrow function as defined below:
leukocytes \>3,000/mcL absolute neutrophil count \>1,500/mcL platelets \>100,000/mcL total bilirubin ≤2X institutional upper limit of normal AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal creatinine within normal institutional limits OR According to Johns Hopkins MRI policy
6. Women of child bearing potential (WOCBP) using a reliable form of contraception during the study treatment period and for up to 12 weeks following the last dose of study drug \[21\].
7. Men must agree to the use of male contraception during the study treatment period and for at least 12 weeks after the last dose of study drug.
8. Ability to understand and the willingness to sign written informed consent document(s).
Exclusion Criteria:
1. Prior whole brain radiation or conventional radiation to the spine at the site of new lesion.
2. Prior chemotherapy within 28 days of starting treatment.
3. Prior therapy with investigational drugs within 28 days or at least 5 half-lives (whichever is longer) before study administration.
4. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody.
5. Neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
6. Known allergy to compounds of similar chemical or biologic composition to ipilimumab.
7. Pregnant or breastfeeding women.
8. Known history of Human Immunodeficiency Virus.
9. Active infection requiring therapy, positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) \[11\].
10. Active autoimmune disease, history of autoimmune disease or history of syndrome that required systemic steroids or immunosuppressive medications. Exceptions include those with vitiligo or resolved childhood asthma/atopy. Subjects with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study \[11\].
11. Use of any vaccines against infectious diseases (e.g. varicella, influenza, etc.) up to 4 weeks (28 days) before receiving ipilimumab.
12. Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.
13. Patients with both brain and spine metastases will be excluded from the trial.
14. Patients who are allergic to MRI contrast agent or have contraindication for MRI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01950195
Study Brief:
Protocol Section:
NCT01950195