19
Participants
Start Date
July 18, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2027
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."
NOT_YET_RECRUITING
Charité - Universitätsmedizin Berlin, Berlin
RECRUITING
Hospital La Paz, Madrid
RECRUITING
Consorcio Hospital General Universitario de Valencia, Valencia
NOT_YET_RECRUITING
Institut Catala d'Oncologia (ICO) Hospitalet, L'Hospitalet de Llobregat
INMUNOCORE
UNKNOWN
Grupo Español Multidisciplinar de Melanoma
OTHER