OncoMatch/Clinical Trials/NCT05549297
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Is NCT05549297 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including Tebentafusp and Tebentafusp with Pembrolizumab for advanced melanoma.
Treatment: Tebentafusp · Tebentafusp with Pembrolizumab · Investigators Choice — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Melanoma
Biomarker criteria
Required: HLA-A A*02:01-positive
HLA-A*02:01-positive
Allowed: BRAF V600 mutation
have a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
Disease stage
Required: Stage III, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1/PD-L1 therapy
have not progressed on treatment with an anti-PD(L)1 mAb
Must have received: anti-CTLA-4 therapy
have not received prior treatment with an approved anti-CTLA-4 mAb
Cannot have received: ImmTAC medication
received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Arizona · Phoenix, Arizona
- Mayo Clinic Florida · Jacksonville, Florida
- Orlando Health Cancer Institute · Orlando, Florida
- Winship Cancer Institute of Emory University · Atlanta, Georgia
- University of Kansas Cancer Center - Westwood · Westwood, Kansas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05549297 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ImmTAC medication disqualifies patients from enrollment.
Does this trial require HLA-A?
Yes, HLA-A A*02:01-positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage III or IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages