OncoMatch/Clinical Trials/NCT05727904
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
Is NCT05727904 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Lifileucel plus Pembrolizumab and Pembrolizumab with Optional Crossover Period for metastatic melanoma.
Treatment: Lifileucel plus Pembrolizumab · Pembrolizumab with Optional Crossover Period — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Melanoma
Biomarker criteria
Allowed: BRAF V600 mutation
Participants with a BRAF V600 mutation-positive tumor received prior adjuvant/neoadjuvant ICI therapy only
Disease stage
Required: Stage IIIC, IIID, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic therapy
Exception: adjuvant/neoadjuvant ICI therapy only for BRAF V600 mutation-positive tumors
Participant received prior therapy for metastatic disease
Lab requirements
Blood counts
Kidney function
Liver function
Participants must have adequate organ function.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham: The Kirklin Clinic · Birmingham, Alabama
- City of Hope · Duarte, California
- USC Norris Comprehensive Cancer Center · Los Angeles, California
- California Pacific Medical Center · San Francisco, California
- University of Colorado Cancer Center · Aurora, Colorado
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05727904 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IIIC or IIID or IV is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages