OncoMatch/Clinical Trials/NCT05549297
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Is NCT05549297 recruiting? Yes, currently enrolling (May 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
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 →
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