Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM) (NCT05549297)
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)
🩺 Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (22 items).
Location: Mayo Clinic Arizona — Phoenix, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (82 Sites)
Showing the first 25 of 82 sites.
- Mayo Clinic Arizona — Phoenix, Arizona
- Mayo Clinic Florida — Jacksonville, Florida
- Orlando Health Cancer Institute — Orlando, Florida
- Winship Cancer Institute of Emory University — Atlanta, Georgia
- University of Kansas Cancer Center - Westwood — Westwood, Kansas
- St Elizabeth Healthcare (St Elizabeth Medical Center) — Edgewood, Kentucky
- St Elizabeth Healthcare (St Elizabeth Medical — Edgewood, Kentucky
- Massachusetts General Hospital — Boston, Massachusetts
- Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- University of Minnesota Medical Center — Minneapolis, Minnesota
- Mayo Clinic Minnesota — Rochester, Minnesota
- Washington University School of Medicine — St Louis, Missouri
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Northwell Health Cancer Institute - Zuckerberg Cancer Center — Lake Success, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- The Ohio State University Comprehensive Cancer Center — Columbus, Ohio
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma
- Thomas Jefferson University Medical Oncology Clinic — Philadelphia, Pennsylvania
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania
- Gibbs Cancer Center and Research Institute — Spartanburg, South Carolina
- University of Tennessee Medical Center — Knoxville, Tennessee
- Houston Methodist Hospital/Houston Methodist Cancer Center — Houston, Texas
- University of Utah Huntsman Cancer Institute — Salt Lake City, Utah
- Fred Hutchinson Cancer Center — Seattle, Washington
📞 Contact the Study Coordinator
Phone: (844) 466-8661
Email: medical.information@immunocore.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Advanced Melanoma
- Memory-Like Natural Killer Cells With Nivolumab and Relatlimab in Advanced or Metastatic Melanoma After Progression on Checkpoint Inhibitors — St Louis, Missouri
- FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma — Charlottesville, Virginia
- Using Biomarkers to Help Guide Safe Immunotherapy Discontinuation in Patients With Unresectable Stage IIIB-IV Melanoma, The PET-Stop Trial — Fairhope, Alabama
- Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery — Birmingham, Alabama
- Naltrexone and Propranolol Combined With Immunotherapy — New Brunswick, New Jersey
Explore by condition: All Advanced Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.