Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III Metastatic Testicular Germ Cell Tumors

This phase I trial evaluates whether adding Pedmark to standard of care cisplatin-based chemotherapy reduces drug-induced ear damage (ototoxicity) in men with stage II-III testicular germ cell tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Cisplatin-induced ototoxicity remains a major concern in adult patients with germ cell tumors as nearly four out of five patients develop hearing loss after treatment. Cisplatin is thought to cause ear damage by the production of chemically reactive molecules called reactive oxygen species. These molecules can cause damage when their levels get too high. Pedmark may reduce the negative side effects of cisplatin by neutralizing these reactive molecules. Pedmark has been approved for reducing the risk of cisplatin-induced ototoxicity in pediatric patients and older patients with solid tumors that haven't spread to other parts of the body. Adding Pedmark to cisplatin-based chemotherapy treatment may reduce ototoxicity in adult men with stage I-III testicular metastatic germ cell tumors.

NCT Number	NCT07218913
Lead Sponsor	City of Hope Medical Center Collaborators: National Cancer Institute (NCI)
Conditions	Hearing Loss, Metastatic Malignant Germ Cell Tumor, Metastatic Malignant Nongerminomatous Germ Cell Tumor, Metastatic Malignant Testicular Non-Seminomatous Germ Cell Tumor, Metastatic Testicular Seminoma, Stage II Testicular Cancer AJCC v8, Stage III Testicular Cancer AJCC v8
Enrollment	44 participants
Start Date	2026-02-19
Primary Completion	2031-01-22 (estimated)
Study Completion	2031-01-22 (estimated)
Updated on ClinicalTrials.gov	2026-04-17