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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.

Phase 3RecruitingImmunocore LtdNCT05549297Data as of May 2026

Treatment: Tebentafusp · Tebentafusp with Pembrolizumab · Investigators ChoiceThe 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.

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Extracted 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

Min 1 prior line

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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