In such cases, the most effective treatment is a combination of gemcitabine, oxaliplatin, and paclitaxel paired with subsequent aggressive surgery. 1 Even if GCTs relapse after initial chemotherapy, patients may be treated with second-line standard-dose chemotherapy or high-dose chemotherapy 2, 3 however, there is no established treatment for patients with consistently relapsing GCT. The high susceptibility of GCTs to chemotherapy indicates that up to 80% of patients with advanced GCTs can be cured by chemotherapy and surgery.
While a small subset of chemorefractory germ cell tumors may respond to nivolumab, programmed death ligand-1 is unreliable to measure response. Genomic sequencing revealed a high tumor mutation burden in a patient with a durable partial response. Programmed death ligand-1 expression was not associated with objective responses. Nivolumab was well-tolerated, with only two Grade 3 adverse events observed. Responses were durable in one patient with a partial response and one patient with stable disease (median 90 and 68 weeks, respectively). One patient showed a partial response and three showed stable disease. The median number of nivolumab doses was 3 (range 2–46). Patients were pretreated with a median of three chemotherapy lines, and three patients received high-dose chemotherapy. Tumor histology revealed nonseminoma and seminoma in 14 and three patients, respectively. We performed a biomarker analysis of programmed death ligand-1 expression and genomic sequencing. The primary endpoint was the overall response rate. Nivolumab was administered over 30 min at 240 mg/body every 2 weeks until disease progression or intolerable adverse event occurrence.
Seventeen adult patients (median age 34 years) with refractory primary germ cell tumor after second-line or higher chemotherapy were enrolled. Therefore, in this phase II study, we evaluated the efficacy and safety of nivolumab for relapsed germ cell tumor.
Germ cell tumors are highly susceptible to chemotherapy however, there is a lack of established treatments for consistently relapsing germ cell tumor.
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