Japanese Phase II Trial Shows Activity of Nivolumab in Platinum-Resistant Ovarian Cancer


Key Points

  • The overall response rate with nivolumab was 15%.
  • Responses included two durable complete responses at the 3-mg/kg dose.

In a Japanese phase II trial reported in the Journal of Clinical Oncology, Hamanishi et al found that the anti–PD-1 (programmed cell death protein 1) antibody nivolumab (Opdivo) was active in patients with relapsed or advanced platinum-resistant ovarian cancer.

Study Details

In the study, 20 patients received nivolumab 1 mg/kg (n = 10) or 3 mg/kg (n = 10) via intravenous infusion every 2 weeks for up to 1 year or until disease progression. The primary endpoint was best overall response. Patients had a median age of 60 years; disease stage was I in 10%, III in 70%, and IV in 20%; histology was serous in 75% and endometrioid in 15%; 55% had received at least four prior chemotherapy regimens; and Eastern Cooperative Oncology Group performance status was 0 for 90% and 1 for 10%.


Median follow-up was 11 months, and median duration of nivolumab treatment was 3.5 months (range = 1–12 months). Response was observed in three patients (15%), including two with durable complete responses in the 3-mg/kg group. The disease control rate was 45%, median progression-free survival was 3.5 months (95% confidence interval [CI] = 1.7–3.9 months), and median overall survival was 20.0 months (95% CI = 7.0 months to not reached).

Adverse Events

The most common treatment-related adverse events of any grade were increased aspartate transaminase (40%), hypothyroidism (40%), and lymphocytopenia (35%). Grade 3 or 4 treatment-related adverse events occurred in 40%, with the most common being lymphocytopenia (15%), anemia (15%), and decreased albumin (10%).

The investigators concluded: “This study, to our knowledge, is the first to explore the effects of nivolumab against ovarian cancer. The encouraging safety and clinical efficacy of nivolumab in patients with platinum-resistant ovarian cancer indicate the merit of additional large-scale investigations.”

Junzo Hamanishi, MD, PhD, of Kyoto University Graduate School of Medicine, is the corresponding author of the Journal of Clinical Oncology article.

The study was supported by a Health and Labour Sciences Research grant and a grant from the Translational Research Network Program of the Ministry of Education, Culture, Sports, Science, and Technology of Japan. For full disclosures of the study authors, visit

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