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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT02791594
Eligibility Criteria:
Inclusion Criteria:
* The subject must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
* The subject must be ≥ 18 years of age on day of signing informed consent.
* The subject must have biopsy proven or clinically documented advanced stage metastatic melanoma.
* The subject must have measurable disease (per RECIST 1.1) that is seen on CT, MRI, or FDG PET/CT.
* The subject must be recommended to start pembrolizumab.
Exclusion Criteria:
* Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.
* Subject is not able to tolerate imaging procedures in the opinion of the investigator or treating physician.
* Subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Subject has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent as assessed by medical record review and/or self-reported.
* Subject has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies) as determined by medical record review.
* Subject has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
* Subject has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected) as determined by medical record review.
* Subject has known active central nervous system metastases and/or carcinomatous meningitis.
Note: Subjects with previously treated brain metastases will be eligible to participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to receiving pembrolizumab and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02791594
Study Brief:
Protocol Section:
NCT02791594