How many clinical trials are studying Tebentafusp?

6 recruiting trials in our tracked data involve Tebentafusp.

What conditions is Tebentafusp being studied for?

In our tracked recruiting trials, Tebentafusp is being studied in trials for Melanoma, Metastatic Uveal Melanoma, Uveal Melanoma.

Tebentafusp: clinical trials recruiting now

Q: Is Tebentafusp FDA-approved?

Yes. According to the FDA drug label available through openFDA, Tebentafusp is an FDA-approved drug. Its FDA label carries a boxed warning.

Recruiting trials

Conditions studied

US states with sites

Countries

FDA drug label

FDA-approved: Yes. Tebentafusp appears in the FDA drug-label database. Marketed as KIMMTRAK.
Drug class: Bispecific gp100 Peptide-HLA-directed CD3 T Cell Engager (FDA established pharmacologic class)
Mechanism of action: Glycoprotein 100 Peptide-Human Leukocyte Antigen-directed Antibody Interactions; CD3-directed Antibody Interactions; CD3 Receptor Agonists (as stated on the FDA label)
Boxed warning: The FDA label for Tebentafusp carries a boxed warning (the FDA's most serious warning). See the full label for details.

FDA-approved use

KIMMTRAK is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma. KIMMTRAK is a bispecific gp100 peptide-HLA-directed CD3 T cell engager indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma ( 1 , 2.1 ).

FDA label via openFDA

Phase breakdown

Phase 2 4 Phase 3 2

Conditions being studied

Condition	Trials
Melanoma · Tebentafusp for Melanoma	6
Metastatic Uveal Melanoma	2
Uveal Melanoma	2
Advanced Melanoma	1
Mestastatic Uveal Melanoma	1
Metastatic Uveal Melanoma in the Liver	1

Recruiting trials involving Tebentafusp

Adjuvant Tebentafusp in High Risk Ocular Melanoma
NCT06246149 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 15 locations
Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma
NCT07057596 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 4 locations
Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma
NCT07276386 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
NCT06627244 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 1 location
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
NCT05549297 · Phase: Phase 3 · Ages: 18 Years and older · Sex: All (male and female) · 82 locations
Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
NCT06070012 · Phase: Phase 2 · Ages: 18 Years and older · Sex: All (male and female) · 3 locations

Common questions

Is Tebentafusp FDA-approved?

Yes, marketed as KIMMTRAK. Its FDA label carries a boxed warning.

How many recruiting trials involve Tebentafusp?

6 recruiting trials across 6 conditions.

Is this list of trials complete?

No. For the full record, search ClinicalTrials.gov.