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 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT02180061
Eligibility Criteria:
Inclusion criteria:
* Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* At least one measurable lesion
* Adequate organ function
Exclusion criteria:
* Prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD ligand-1 (PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agent
* Is currently participating or has participated in a study with an investigational compound or device within 30 days, or 5X half-life of the investigational compound, whichever is longer, of initial dosing on this study
* Chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (including monoclonal antibodies) within 4 weeks prior to the first dose of trial treatment, or not recovered (\<= Grade 1 or baseline) from adverse events due to a previously administered agent
* Expected to require any other form of systemic or localized antineoplastic therapy while in study
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
* Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study treatment
* Received a live vaccine within 4 weeks prior to the first dose of trial treatment
* Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
* History or evidence of active pneumonitis
* Human immunodeficiency virus (HIV)-positive
* Has known history of active Hepatitis B or C
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial treatment through 120 days after the last dose of study medication
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02180061
Study Brief:
Protocol Section:
NCT02180061