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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 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.

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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.

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

FieldValue
Enrollment Target 540 participants
Start Date 2022-12-19
Est. Completion 2028-07
Phase Phase 3

Sponsor

Immunocore

8 total trials

What the Registry Record Tells You About NCT05549297

The ClinicalTrials.gov registry entry for NCT05549297 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 540 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 146-participant average among 21 other Advanced Melanoma trials with a reported enrollment target (270% higher). The listed sponsor is Immunocore, which has 8 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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