Phase II Study of Disitamab Vedotin and Toripalimab for Advanced HER2-Positive Extramammary Paget Disease of the Scrotum

What this Trial Is About

Researchers are evaluating the combination of Disitamab Vedotin and Toripalimab to treat advanced HER2-positive extramammary Paget disease of the scrotum. This phase II clinical trial aims to determine if this combination reduces tumor size and delays disease progression, while also studying the safety and medical problems that may occur during treatment. Participants will receive intravenous infusions of Disitamab Vedotin at 2mgkg and Toripalimab at 3mgkg every 3 weeks. Treatment continues until the disease progresses, intolerable side effects occur, or other specified reasons arise. The study includes regular clinical tumor imaging and lesion measurements during treatment. Participants visit the clinic every 3 weeks for checkups and tests, including assessments of tumor response using RECIST criteria. The main outcome measured is the objective response rate every 6 weeks for up to 24 weeks. Secondary outcomes include progression-free survival and adverse events monitored over an average of 2 years. Follow-up continues until disease progression, withdrawal, loss to follow-up, or death.

A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum