Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
ConditionAdvanced Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunocore Ltd
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tebentafusp
- Tebentafusp with Pembrolizumab
- Investigators Choice
Treatment groups
540 Participants
are divided into 3 treatment groupsLocations
82Australia
Melanoma Institute Australia2065, WollstonecraftNew South Wales, Australia
Gallipoli Medical Research Foundation (GMRF)4120, GreenslopesQueensland, Australia
Princess Alexandra Hospital4102, WoolloongabbaQueensland, Australia
Alfred Health3004, MelbourneVictoria, Australia
Sponsors and collaborators
Immunocore Ltd
Lead sponsor
Source ClinicalTrials.gov