NCT05549297

Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Immunocore Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase 3 (as upon conversion to phase 3 there were no changes to the arms listed herein), multicenter, open-label study to evaluate the efficacy and safety of tebentafusp as monotherapy (Arm A) and in combination with pembrolizumab (Arm B) compared with standard of care or best supportive care (Arm C) in participants with non-ocular advanced melanoma who have progressed on a prior anti-PD(L)1 regimen, received an approved anti-CTLA4 regimen and, if the participant has a BRAF mutation, a prior BRAF tyrosine kinase inhibitor (TKI) regimen.

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Tebentafusp	Soluble gp100-specific T cell receptor with anti-CD3 scFV
DRUG	Tebentafusp with Pembrolizumab	Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab
DRUG	Investigators Choice	Investigators choice of therapy

Timeline

• Start date: 2022-12-19
• Primary completion: 2028-03-01
• Completion: 2028-07-01
• First posted: 2022-09-22
• Last updated: 2026-02-25

Locations

82 sites across 12 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study