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 @ 12:17 AM
Ignite Modification Date:
2025-12-25 @ 12:17 AM
NCT ID:
NCT03903458
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Patients with either histologically or cytologically confirmed inoperable stage III or metastatic stage IV melanoma
* Indication for the regular systemic treatment with the anti-PD-1 monoclonal antibody Nivolumab monotherapy
* Patient received a maximum of 1 prior systemic palliative line of treatment
* ECOG ≤2
* Patients with brain metastases must have undergone definitive treatment (surgery or radiotherapy) at least 2 weeks prior to starting study drug and be documented as having stable disease by imaging
* Adequate bone marrow, renal and hepatic function
* Adequate contraception
Exclusion Criteria:
* Prior treatment with a PD-(L)1 targeted monoclonal antibody
* Patients who have received systemic treatments or radiotherapy within 2 weeks prior to starting study drug
* Concomittant treatment with systemic steroids at a daily dose equivalent to ≥10mg of prednisone, or concomittant treatment with immunosuppressive drugs such as methotrexate
* Patients with a prior malignancy are excluded (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, colon,cervical/dysplasia, melanoma, or breast). Patients with other second malignancies diagnosed more than 2 years ago who have received therapy with curative intent with no evidence of disease during the interval who are considered by the Investigator to present a low risk for recurrence will be eligible.
* NYHA stage III/IV congestive heart failure and/or arrhythmia not adequately controlled
* QTc interval (Fridericia's formula) \> 450msec
* Patients who are on treatment with drugs known to prolong the QT/QTc interval (Credible Meds list:
Known risk of TdP. https://www.crediblemeds.org).
* Pregnant and breast feeding patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03903458
Study Brief:
Protocol Section:
NCT03903458