Brief Summary
This is a Phase 3, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of lifileucel in combination with pembrolizumab compared with pembrolizumab alone in participants with untreated, unresectable or metastatic melanomaa type of cancer that develops from melanocytes, which are the cells that produce pigment generally in the skin (but can develop in other areas of the body). Participants randomized to the pembrolizumab monotherapy arm who subsequently have a blinded independent central review- verified confirmed progressive disease (PD) will be offered lifileucel monotherapy in an optional crossover period.
Intervention / Treatment
- Biological: Lifileucel plus Pembrolizumab
- Biological: Pembrolizumab with Optional Crossover Period
Inclusion Criteria:
- Participant has a histologically or pathologically confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of Stage IIIC, IIID, or IV unresectable or metastatic melanoma.
- In the investigator’s assessment, the participant has an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of > 6 months.
- 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 resectionsurgical removal of tissue or part/all of an organ.
- Participants must have adequate organ function.
- 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 who are > 70 years of age may be allowed to enroll after the investigator discusses with the medical monitorto check on, keep track of.