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Phase II trial of nivolumab monotherapy and biomarker screening in patients with chemo‐refractory germ cell tumors.
- Source :
-
International Journal of Urology . Jul2022, Vol. 29 Issue 7, p741-747. 7p. - Publication Year :
- 2022
-
Abstract
- Objectives: Germ cell tumors are highly susceptible to chemotherapy; however, there is a lack of established treatments for consistently relapsing germ cell tumor. Therefore, in this phase II study, we evaluated the efficacy and safety of nivolumab for relapsed germ cell tumor. Methods: Seventeen adult patients (median age 34 years) with refractory primary germ cell tumor after second‐line or higher chemotherapy were enrolled. Nivolumab was administered over 30 min at 240 mg/body every 2 weeks until disease progression or intolerable adverse event occurrence. The primary endpoint was the overall response rate. Result: We performed a biomarker analysis of programmed death ligand‐1 expression and genomic sequencing. Tumor histology revealed nonseminoma and seminoma in 14 and three patients, respectively. Patients were pretreated with a median of three chemotherapy lines, and three patients received high‐dose chemotherapy. The median number of nivolumab doses was 3 (range 2–46). One patient showed a partial response and three showed stable disease. Responses were durable in one patient with a partial response and one patient with stable disease (median 90 and 68 weeks, respectively). Nivolumab was well‐tolerated, with only two Grade 3 adverse events observed. Programmed death ligand‐1 expression was not associated with objective responses. Genomic sequencing revealed a high tumor mutation burden in a patient with a durable partial response. While a small subset of chemorefractory germ cell tumors may respond to nivolumab, programmed death ligand‐1 is unreliable to measure response. Conclusions: Tumor mutation burden is a potential biomarker for future testing of germ cell tumor response. [ABSTRACT FROM AUTHOR]
- Subjects :
- *NIVOLUMAB
*GERM cell tumors
*BIOMARKERS
Subjects
Details
- Language :
- English
- ISSN :
- 09198172
- Volume :
- 29
- Issue :
- 7
- Database :
- Academic Search Index
- Journal :
- International Journal of Urology
- Publication Type :
- Academic Journal
- Accession number :
- 157801507
- Full Text :
- https://doi.org/10.1111/iju.14885