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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT05002569
Eligibility Criteria:
Inclusion Criteria:
* Must have been diagnosed with either Stage IIIA (\> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
* Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and \< 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
* Complete resection must be performed within 90 days prior to randomization
* All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
* Tumor tissue must be provided for biomarker analyses
Exclusion Criteria:
* History of ocular melanoma
* Untreated/unresected CNS metastases or leptomeningeal metastases
* Active, known, or suspected autoimmune disease
* Participants with serious or uncontrolled medical disorder
* Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
* History of myocarditis, regardless of etiology.
Other protocol-defined inclusion/exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05002569
Study Brief:
Protocol Section:
NCT05002569