Conditions

Metastatic Melanoma

Unresectable Melanoma

Melanoma

Purpose of the study

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 melanoma. 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. NCT05727904   

Official Title

A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma. 

Who is eligible to participate?

• Participant has a histologically or pathologically confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma. 

• In the investigator’s assessment, the participant has an Eastern Cooperative Oncology 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 resection. 

• 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 enrol after the investigator discusses with the medical monitor. 

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