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NCT05727904 · ClinicalTrials.gov registry record · Phase 3
Study to Investigate Lifileucel Regimen Plus Pembrolizumab Compared With Pembrolizumab Alone in Participants With Untreated Advanced Melanoma.
A Phase 3 study of Melanoma and Metastatic Melanoma, sponsored by Iovance Biotherapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 670
- Enrollment target
- 20
- Study locations
NCT05727904: Recruiting Phase 3 study of Melanoma and Metastatic Melanoma, sponsored by Iovance Biotherapeutics.
NCT05727904 is a Phase 3 study of Melanoma and Metastatic Melanoma that is actively recruiting participants, run by Iovance Biotherapeutics. The registered enrollment target is 670 participants, roughly in line with the 704-participant average among 266 other Melanoma trials with a reported enrollment target. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05727904, a Phase 3 study of Melanoma and Metastatic Melanoma, is actively recruiting participants, sponsored by Iovance Biotherapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 670 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
To compare the efficacy of lifileucel plus pembrolizumab with the efficacy of pembrolizumab alone measured by objective response rate (ORR) and progression-free survival (PFS) assessed by the blinded independent review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
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 |
What NCT05727904 shows while recruiting
NCT05727904 is an interventional study that assigns participants to a tested intervention. The registered 670 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 704-participant average among 266 other Melanoma trials with a reported enrollment target.
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.
NCT05727904 names 20 study sites across 14 states, led by California, Michigan, Ohio.
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.
What interventions are being tested in trial NCT05727904?
The interventions under investigation include: Lifileucel plus Pembrolizumab (BIOLOGICAL), Pembrolizumab with Optional Crossover Period (BIOLOGICAL).
Who is sponsoring clinical trial NCT05727904?
This trial is sponsored by Iovance Biotherapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05727904's enrollment target sits among peer trials
670 32nd of 266 higher than 235 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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