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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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 670 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 704-participant average among 266 other Melanoma trials with a reported enrollment target. The listed sponsor is Iovance Biotherapeutics, which has 12 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
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Related
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