Ashkar, RyanFeldman, Darren R.Adra, NabilZaid, Mohammad AbuFunt, Samuel A.Althouse, Sandra K.Perkins, Susan M.Snow, Christin I.Lazzara, Kayla M.Sego, Lina M.Quinn, David I.Hanna, Nasser H.Einhorn, Lawrence H.Albany, Costantine2023-10-102023-10-102021Ashkar R, Feldman DR, Adra N, et al. Phase II trial of brentuximab vedotin in relapsed/refractory germ cell tumors. Invest New Drugs. 2021;39(6):1656-1663. doi:10.1007/s10637-021-01134-1https://hdl.handle.net/1805/36229Background: CD-30 is highly expressed in some patients with non-seminomatous germ-cell tumors. Brentuximab vedotin is an antibody–drug conjugate directed to CD-30. We report a phase 2 trial of brentuximab vedotin in patients with chemo-refractory GCT. Patients and methods: This is a single arm, two cohort phase 2 trial investigating brentuximab vedotin 1.8 mg/kg IV every 3 weeks until disease progression or intolerable toxicities in patients with relapsed GCT who have no curative options. Patients with mGCT who progressed after first line cisplatin-based chemotherapy and after at least 1 salvage regimen (high-dose or standard-dose chemotherapy) were eligible. CD30 expression was assessed and two cohorts defined: CD30 positive and CD30 negative/unknown. Results: 18 patients were enrolled. Median age 34.7 (range, 23–56). All patients had non-seminoma. Median AFP 4.9 (range, 1–219,345) and hCG 282 (range, 0.6–172,064). Five patients had late relapse (> 2 years). Median number of previous chemotherapy regimens was 3 (range, 2–7). Ten patients received prior high-dose chemotherapy. Seven patients had positive CD30 staining. There were two grade 3 treatment-related adverse events. No partial or complete responses were observed. 6 patients achieved radiographic stable disease (range, 9–14.9 weeks), 5 had elevated AFP or hCG at trial entry and all 5 had transient > 50% decline in baseline AFP/hCG: 4 had CD30 −ve and 2 had CD30 + ve staining; 10 patients had progression of disease as their best response; 2 were not evaluable for response. Conclusion: Brentuximab vedotin does not appear to have clinically meaningful single-agent activity in patients with refractory GCT.en-USPublisher PolicyBrentuximab vedotinGerm cell tumorRelapsed testicular cancerTesticular cancerArticle