Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

July 18, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Mestastatic Uveal Melanoma
Interventions
DRUG

Tebentafusp

"Patients will receive tebentafusp intravenously (IV) weekly for 6 months with liver directed imaging every 2 months to identify rapid progressors. Tebentafusp will be administered at 20 micrograms on W1D1, 30 micrograms on W2D1, and 68 micrograms once every week thereafter.~After 6 months, patients with complete response (CR) according to RECIST will continue tebentafusp therapy (surgery might be an option if deem appropriate by local PI); while patients achieving partial response or stable disease will be evaluated for tumor resection and will enter into Surgery phase. Surgery will be conducted 7 months (+/- 1 month). If progressioh disease (PD) occurs earlier surgery can happen earlier. After surgery, patients without pCR or R0 surgery will maintain tebentafusp until disease relapse, unacceptable toxicity or patient withdrawal. Patients with pCR and R0 will continue tebentafusp therapy for 1 additional year or until disease relapse, unacceptable toxicity or patient withdrawal."

Trial Locations (4)

10117

NOT_YET_RECRUITING

Charité - Universitätsmedizin Berlin, Berlin

28046

RECRUITING

Hospital La Paz, Madrid

46014

RECRUITING

Consorcio Hospital General Universitario de Valencia, Valencia

08908

NOT_YET_RECRUITING

Institut Catala d'Oncologia (ICO) Hospitalet, L'Hospitalet de Llobregat

All Listed Sponsors
collaborator

INMUNOCORE

UNKNOWN

lead

Grupo Español Multidisciplinar de Melanoma

OTHER

NCT07057596 - Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma | Biotech Hunter | Biotech Hunter