Trial ID # | NCT03245892 |
Phase | I |
Drug Class | Immunotherapy: Checkpoint Inhibitors/PD-1 |
Drug Name | Nivolumab |
Alternate Drug Names | BMS-936558, ONO-4538, MDX-1106, Anti-PD-1 human mab MDX-1106, Opdivo |
Drugs in Trial | Carboplatin, Nivolumab, Paclitaxel |
Eligible Participant | Newly diagnosed stage III/IV high grade serous ovarian cancer (neo-adjuvant) |
Patients Enrolled | 20 |
Therapy Setting | First-line |
Study Design | Open-Label, Non-randomized |
Endpoints | PFS, evaluated per RECIST |
Efficacy | 90% achieved optimal cytoreducation at IDS (70% R0, 20% R1) |
Clinically Significant Adverse Events | Serious AE: |
Conclusion | In high-risk ovarian cancer patients, addition of nivolumab to neoadjuvant chemotherapy and as maintenance shows promising PFS and favorable changes in the tumor microenvironment |
Reference | Friedman CF et al. A pilot study of nivolumab in combination with front-line neoadjuvant dose-dense paclitaxel and carboplatin chemotherapy in patients with high-grade serous ovarian cancer. SGO (2020) abstract 5 Friedman CF et al. Slide from presentation |