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 groupsSponsors and collaborators
Source ClinicalTrials.gov