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Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
NCT05727904 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- BIOLOGICAL Lifileucel plus Pembrolizumab
- BIOLOGICAL Pembrolizumab with Optional Crossover Period
Study Locations (20)
California
- City of Hope — Duarte
- USC Norris Comprehensive Cancer Center — Los Angeles
- California Pacific Medical Center — San Francisco
Michigan
- Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center — Detroit
- Henry Ford Health — Detroit
Ohio
- Oncology Hematology Care — Cincinnati
- Ohio State University — Columbus
Pennsylvania
- St. Luke's Cancer Center - Anderson — Easton
- Allegheny Health Network — Pittsburgh
Tennessee
- Baptist Cancer Center — Bartlett
- SCRI Oncology Partners — Nashville
Alabama
- University of Alabama at Birmingham: The Kirklin Clinic — Birmingham
Colorado
- University of Colorado Cancer Center — Aurora
Florida
- Orlando Health Cancer Institute — Orlando
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 670 participants |
| Start Date | 2023-03-30 |
| Est. Completion | 2030-03-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05727904
The ClinicalTrials.gov registry entry for NCT05727904 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 670 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Iovance Biotherapeutics, which has 128 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Melanoma appearing as the primary indexed condition, and to 2 interventions — of which Lifileucel plus Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05727904 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Michigan, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05727904 about?
NCT05727904 is a clinical study titled "Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.". 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 ...
What is the current status of trial NCT05727904?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 670 participants. The study started on 2023-03-30. Estimated completion is 2030-03-01.
What conditions does trial NCT05727904 study?
This clinical trial studies the following conditions: Melanoma, Metastatic Melanoma, Unresectable Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05727904?
The interventions under investigation include: Lifileucel plus Pembrolizumab (BIOLOGICAL), Pembrolizumab with Optional Crossover Period (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05727904?
This trial is sponsored by Iovance Biotherapeutics, which has 128 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05727904 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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