Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Recruiting · NCT05549297 · Interventional (participants receive a specific treatment) · Lead sponsor: Immunocore Ltd
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 18 US states.
- Mayo Clinic Arizona - Phoenix, Arizona, United States
- Mayo Clinic Florida - Jacksonville, Florida, United States
- Orlando Health Cancer Institute - Orlando, Florida, United States
- Winship Cancer Institute of Emory University - Atlanta, Georgia, United States
- University of Kansas Cancer Center - Westwood - Westwood, Kansas, United States
- St Elizabeth Healthcare (St Elizabeth Medical Center) - Edgewood, Kentucky, United States
- St Elizabeth Healthcare (St Elizabeth Medical - Edgewood, Kentucky, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center (BIDMC) - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- University of Minnesota Medical Center - Minneapolis, Minnesota, United States
- Mayo Clinic Minnesota - Rochester, Minnesota, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Rutgers Cancer Institute of New Jersey - New Brunswick, New Jersey, United States
- Northwell Health Cancer Institute - Zuckerberg Cancer Center - Lake Success, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- The Ohio State University Comprehensive Cancer Center - Columbus, Ohio, United States
- OU Health Stephenson Cancer Center - Oklahoma City, Oklahoma, United States
- Thomas Jefferson University Medical Oncology Clinic - Philadelphia, Pennsylvania, United States
- UPMC Hillman Cancer Center - Pittsburgh, Pennsylvania, United States
- Gibbs Cancer Center and Research Institute - Spartanburg, South Carolina, United States
- University of Tennessee Medical Center - Knoxville, Tennessee, United States
- Houston Methodist Hospital/Houston Methodist Cancer Center - Houston, Texas, United States
- University of Utah Huntsman Cancer Institute - Salt Lake City, Utah, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Hospital Clinico de Barcelona - Barcelona, Spain
- Charité - Campus Charité Mitte - Berlin, Germany
- CHU de Bordeaux - Hopital Saint Andre - Bordeaux, France
- Cliniques Universitaires Sain-Luc - Brussels, Belgium
- Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy - Bydgoszcz, Poland
- Universitatsklinikum Carl Gustav Carus Dresden - Dresden, Germany
- Universitaetsklinikum Erlangen - Erlangen, Germany
- Universitaetsklinikum Essen - Essen, Germany
- Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii - Gdansk, Poland
- LKH - Universitaetsklinikum Graz - Graz, Austria
- Universitaetsklinikum Hamburg-Eppendorf - Hamburg, Germany
- Universitaetsklinikum Heidelberg - Heidelberg, Germany
- UZ Brussel - Jette, Belgium
- Universitaetsklinikum Schleswig-Holstein - Kiel, Germany
- Leeds General Infirmary - Leeds, United Kingdom
- UZ Leuven - Leuven, Belgium
- Kepler Universitätsklinikum - Linz, Austria
- Guys & St Thomas' NHS Foundation Trust - London, United Kingdom
- Sarah Cannon Research Institute UK - London, United Kingdom
- Royal Marsden Hospital - Chelsea - London, United Kingdom
- Hospital General Universitario Gregorio Marañon - Madrid, Spain
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Hopital de la Timone [Recruiting] - Marseille, France
- Mount Vernon Cancer Center - Middlesex, United Kingdom
- Fondazione IRCCS Istituto Nazionale dei Tumori - Milan, Italy
- Johannes Wesling Klinikum Minden - Minden, Germany
- Hospital Regional Universitario de Malaga - Málaga, Spain
- LMU-Campus Innenstadt - München, Germany
- Instituto Nazionale Tumori Fondazione G. Pascale - Naples, Italy
- Hopital Saint Lous - APHP - Paris, France
- Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia - Perugia, Italy
- Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Poznan, Poland
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma, Italy
- Universitatsklinik fur Innere Medizin 3 - Salzburg, Austria
Showing 60 of 82 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →