Conditions

Advanced Melanoma

Purpose of the 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. NCT05549297    

Official Title

Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator’s Choice in HLA-A*02:01-positive Participants with Previously Treated Advanced Melanoma (TEBE-AM) 

Who is eligible to participate?

• 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. 

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane