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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT07288203
Eligibility Criteria:
Inclusion Criteria:
* Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
* The participant has an ECOG performance status of 0 or 1 and an estimated life expectancy of \> 6 months.
* The participant must have experienced radiographic disease progression on: 1 prior line of an anti-PD-(L)1 treatment (as a monotherapy or as part of a combination) for advanced melanoma and/or during or within ≤ 12 weeks after adjuvant anti-PD-(L)1 treatment (as a monotherapy or as part of a combination). Participants who have BRAF V600 mutation positive melanoma may have received 1 additional prior line of treatment with a BRAF inhibitor ± a MEK inhibitor.
* Participant is assessed as having at least one resectable lesion (or aggregate lesions) for lifileucel generation.
* Participant must have at least one measurable disease as defined by RECIST 1.1 following tumor resection.
* Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
* Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control.
* Participants must have adequate organ function.
* Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post-treatment tumor assessment.
Exclusion Criteria:
* Participant has melanoma of uveal/ocular origin.
* Participant has symptomatic untreated brain metastases.
* Participant has active uveitis that requires active treatment.
* Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation, such as systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
* Participant has any form of primary or acquired immunodeficiency (eg, SCID or AIDS).
* Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or were curatively treated \>1 year ago, and in the judgment of the investigator do not pose a significant risk of recurrence.)
* Participant has a history of allogeneic cell or organ transplant.
* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Other protocol defined inclusion/exclusion criteria could apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07288203
Study Brief:
Protocol Section:
NCT07288203