Condition

Advanced Melanoma

Purpose of the study

To evaluate the efficacy of lifileucel as measured by ORR (proportion of participants who have a confirmed partial or complete response) per RECIST v1.1 as assessed by the IRC in participants who previously received an anti-PD-(L)1 agent for advanced melanoma and/or prior to early relapse and whose melanoma is either BRAF V600 mutation positive and previously treated with a BRAF inhibitor (± a MEK inhibitor) or is BRAF V600 wild-type (ie, the primary population).

Official Title

A Phase 2, multicenter, open-label study of lifileucel (tumor-infiltrating lymphocytes [TIL]) in participants with previously treated advanced melanoma.

Who is eligible to participate?

Inclusion Criteria

• The participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma. ·
• 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). ·
• The participant has an 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 ·
• Following tumor resection for lifileucel generation, the participant will have at least one measurable lesion, as defined by RECIST v1.1 at Baseline.
• If the participant has preplanned surgical procedure(s), the procedure will take place at least 14 days (for major operative procedures) prior to the tumor resection.
• Participant has recovered from all prior anticancer treatment-related AEs to Grade ≤ 1 (per NCI-CTCAE), except for peripheral neuropathy, alopecia, or vitiligo.
• Contraceptive use by participants or participant partners should be consistent with local regulations for those participating in clinical studies.
• Participant is capable of giving signed informed consent
• Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post-treatment tumor assessment. 

Exclusion criteria:

• Participants with uveal/ocular melanoma or melanoma with known GNAQ or GNA11 mutation.
• 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; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
• Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or AIDS).
• Participant has a history of hypersensitivity to any component of the study intervention
• Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or have been curatively treated > 1 year ago, and in the judgment of the investigator does not pose a significant risk of recurrence)
• Participant has a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
• Participant received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD preparative regimen.
• 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.

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane