RecruitingAdvanced Melanoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

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About this study

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.

Sponsor: Immunocore Ltd

You may qualify if…

✓ HLA-A\*02:01-positive
✓ unresectable Stage III or Stage IV non-ocular melanoma
✓ archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
✓ measurable or non-measurable disease per RECIST 1.1
✓ Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
✓ If applicable, must agree to use highly effective contraception
✓ Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
✓ Must agree to provide protocol specified samples for biomarker analyses.

You may not qualify if…

✕ Pregnant or lactating women
✕ diagnosis of ocular or metastatic uveal melanoma
✕ history of a malignant disease other than those being treated in this study
✕ ineligible to be retreated with pembrolizumab due to a treatment-related AE
✕ known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
✕ previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
✕ active autoimmune disease requiring immunosuppressive treatment
✕ known psychiatric or substance abuse disorders