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NCT05549297 · ClinicalTrials.gov registry record · Phase 3
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
A Phase 3 study of Advanced Melanoma, sponsored by Immunocore.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 540
- Enrollment target
- 20
- Study locations
NCT05549297: Recruiting Phase 3 study of Advanced Melanoma, sponsored by Immunocore.
NCT05549297 is a Phase 3 study of Advanced Melanoma that is actively recruiting participants, run by Immunocore. The registered enrollment target is 540 participants, above the 146-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (270% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05549297, a Phase 3 study of Advanced Melanoma, is actively recruiting participants, sponsored by Immunocore.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 540 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \[SoC\], best supportive care \[BSC\] on protocol survivor follow up) in patients with advanced non-ocular melanoma.
Primary Outcome
OS is the time from randomization to death due to any cause.
Conditions Studied
Interventions
- DRUG Tebentafusp
- DRUG Tebentafusp with Pembrolizumab
- DRUG Investigators Choice
Study Locations (20)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center (BIDMC) - Boston
- Dana Farber Cancer Institute - Boston
Florida
- Mayo Clinic Florida - Jacksonville
- Orlando Health Cancer Institute - Orlando
Kentucky
- St Elizabeth Healthcare (St Elizabeth Medical Center) - Edgewood
- St Elizabeth Healthcare (St Elizabeth Medical - Edgewood
Minnesota
- University of Minnesota Medical Center - Minneapolis
- Mayo Clinic Minnesota - Rochester
New York
- Northwell Health Cancer Institute - Zuckerberg Cancer Center - Lake Success
- Memorial Sloan Kettering Cancer Center - New York
Pennsylvania
- Thomas Jefferson University Medical Oncology Clinic - Philadelphia
- UPMC Hillman Cancer Center - Pittsburgh
Arizona
- Mayo Clinic Arizona - Phoenix
Georgia
- Winship Cancer Institute of Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 540 participants |
| Start Date | 2022-12-19 |
| Est. Completion | 2028-07 |
| Phase | Phase 3 |
What NCT05549297 shows while recruiting
NCT05549297 is an interventional study that assigns participants to a tested intervention. The registered 540 participants enrollment target is mid-sized for trials with a published cap, above the 146-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (270% higher).
The record links to 1 condition, with Advanced Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Tebentafusp is the first listed.
NCT05549297 names 20 study sites across 13 states, led by Massachusetts, Florida, Kentucky.
Frequently Asked Questions
What is clinical trial NCT05549297 about?
NCT05549297 is a clinical study titled "Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)". The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \[SoC\], best sup...
What is the current status of trial NCT05549297?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 540 participants. The study started on 2022-12-19. Estimated completion is 2028-07.
What conditions does trial NCT05549297 study?
This clinical trial studies the following conditions: Advanced Melanoma.
What interventions are being tested in trial NCT05549297?
The interventions under investigation include: Tebentafusp (DRUG), Tebentafusp with Pembrolizumab (DRUG), Investigators Choice (DRUG).
Who is sponsoring clinical trial NCT05549297?
This trial is sponsored by Immunocore, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05549297 being conducted?
This trial has 20 study locations across Arizona, Florida, Georgia, Kansas, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced 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 NCT05549297's enrollment target sits among peer trials
540 3rd of 21 higher than 19 of 21 other Advanced Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced 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.
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