NCT05549297Recruiting
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Summary
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.
Inclusion criteria
• 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.
Exclusion criteria
• 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 • received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication or who have not completed adequate washout from prior medications. • received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose • received cellular therapies within 90 days of study intervention • ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically significant who in the opinion of the investigator could affect the outcome of the study • received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose • have not progressed on treatment with an anti-PD(L)1 mAb • have not received prior treatment with an approved anti-CTLA-4 mAb • have a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen • currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose • known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV) • known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function • Out of range Laboratory values • history of allogenic tissue/solid organ transplant
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Australia, Belgium, Canada, Poland, Spain, United Kingdom
- Sponsor
- Immunocore Ltd(Industry)
- Protocol no.
- IMCgp100-203
- Conditions
- Advanced Melanoma
- Interventions
- Drug
Treatments studied
- Tebentafusp
- Tebentafusp with Pembrolizumab
- Investigators Choice
Locations · 82
- Sankt Gallen, SwitzerlandKantonsspital St. GallenRecruiting at this site
- Zurich, SwitzerlandUniversitaetsspital ZurichRecruiting at this site
- Lyon, FranceCentre Leon BerardRecruiting at this site
- Toulouse, FranceInstitute Claudius RegaudRecruiting at this site
- Villejuif, FranceInstitut Gustave RoussyRecruiting at this site
- Bordeaux, FranceCHU de Bordeaux - Hopital Saint AndreRecruiting at this site
- Marseille, FranceHopital de la Timone [Recruiting]Recruiting at this site
- Paris, FranceHopital Saint Lous - APHPRecruiting at this site
- Schleswig, GermanyUniversitaetsklinikum Schleswig-HolsteinRecruiting at this site
- Berlin, GermanyCharité - Campus Charité MitteRecruiting at this site
- Dresden, GermanyUniversitatsklinikum Carl Gustav Carus DresdenRecruiting at this site
- Erlangen, GermanyUniversitaetsklinikum ErlangenRecruiting at this site
- Essen, GermanyUniversitaetsklinikum EssenRecruiting at this site
- Hamburg, GermanyUniversitaetsklinikum Hamburg-EppendorfRecruiting at this site
- Heidelberg, GermanyUniversitaetsklinikum HeidelbergRecruiting at this site
- Kiel, GermanyUniversitaetsklinikum Schleswig-HolsteinRecruiting at this site
- Minden, GermanyJohannes Wesling Klinikum MindenRecruiting at this site
- München, GermanyLMU-Campus InnenstadtRecruiting at this site
- Tübingen, GermanyUniversitaetsklinikum TübingenRecruiting at this site
- Milan, ItalyFondazione IRCCS Istituto Nazionale dei TumoriRecruiting at this site
- Naples, ItalyInstituto Nazionale Tumori Fondazione G. PascaleRecruiting at this site
- Perugia, ItalyAzienda Ospedaliera di Perugia Ospedale S. Maria della MisericordiaRecruiting at this site
- Roma, ItalyFondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting at this site
- Siena, ItalyA.O.U Senese Policlinico Santa Maria alle ScotteRecruiting at this site
- Graz, AustriaLKH - Universitaetsklinikum GrazRecruiting at this site
- Linz, AustriaKepler UniversitätsklinikumRecruiting at this site
- Salzburg, AustriaUniversitatsklinik fur Innere Medizin 3Recruiting at this site
- Vienna, AustriaAKH - Medizinische Universität WienRecruiting at this site
- Phoenix, United StatesMayo Clinic ArizonaRecruiting at this site
- Jacksonville, United StatesMayo Clinic FloridaRecruiting at this site
In total, worldwide, all 82 sites listed in the registry are recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: February 25, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 52 more locations
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.