Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

Recruiting now · Phase 3

Conditions studied: Advanced Melanoma

In brief

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.

Key facts

Study ID

NCT05549297

Run by

Immunocore Ltd

People needed

540

Starts

2022-12-19

Expected to finish

2028-07-01

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States (enrolling)
• University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States (enrolling)
• St Elizabeth Healthcare (St Elizabeth Medical Center) — Edgewood, Kentucky, United States (enrolling)
• St Elizabeth Healthcare (St Elizabeth Medical — Edgewood, Kentucky, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic Minnesota — Rochester, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• Northwell Health Cancer Institute - Zuckerberg Cancer Center — Lake Success, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)
• OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (enrolling)
• Thomas Jefferson University Medical Oncology Clinic — Philadelphia, Pennsylvania, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Gibbs Cancer Center and Research Institute — Spartanburg, South Carolina, United States (enrolling)
• University of Tennessee Medical Center — Knoxville, Tennessee, United States (enrolling)
• Houston Methodist Hospital/Houston Methodist Cancer Center — Houston, Texas, United States (enrolling)
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)
• Mayo Clinic Arizona — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.