Patologia: melanoma localmente avanzato, non resecabile o metastatico

Fase di studio: fase I

Linea di trattamento: progressione dopo almeno una linea di trattamento e paziente non candidabile ad ulteriori terapie che possano dare beneficio clinico

Inclusion Criteria

1. Male or female aged ≥18 years with diagnosis of melanoma (locally advanced, unresectable or metastatic disease)

2. Progression of disease following at least one prior therapy, and not a candidate for established therapy known to provide clinical benefit (i.e. available treatment options have been exhausted).

3. Measurable disease

4. PS 0 or 1 with adequate organ and marrow function

5. Ability to provide written informed consent

6. Use highly effective contraception

Exclusion Criteria

1. Prior diagnosis of uveal or mucosal melanoma, active other malignancy requiring treatment or active untreated brain metastases.

2. Recent administration of biological agents, chemotherapy, targeted small molecule therapy, radiation therapy or vaccine containing live virus.

3. Prior treatment with CTLA-4-directed therapy in the metastatic setting.

4. Active infection requiring systemic therapy.

5. History or current drug-induced toxicity related to prior anti-cancer therapy.

6. Recent major surgery or surgery planned during the time the subject is expected to participate in the study

7. Active, known or suspected autoimmune disease

8. Systemic chronic steroid therapy (≥10 mg/day prednisone or equivalent) or any immunosuppressive therapy

Trattamento: ADU-1604 (anti-CTLA-4) somministrato endovena ogni 3 settimane per 4 dosi. Lo studio sarà diviso in due parti: una dose-escalation seguita da una dose-expansion per stabilire la Recommended Phase 2 Dose (RP2D) del farmaco oggetto di studio.

Centri partecipanti

Nord Italia

Istituto Oncologico Veneto IRCCS - Sede di Padova
Via Gattamelata, 64 - 35128 Padova
Riferimenti: Dott.ssa Vanna Chiarion Sileni, Dott. Jacopo Pigozzo, Dott.ssa Luisa Piccin