A Pilot Study of Nivolumab With or Without Ipilimumab in Combination With Front-Line Neoadjuvant Dose Dense Paclitaxel and Carboplatin Chemotherapy and Post-Surgical Dose Dense Paclitaxel and Carboplatin Chemotherapy in Patients With High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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 interval surgery (70% R0, 20% R1)
PFS: 15 months
PFS (12 months): 69.6%
Treatment associated w/ significant increase in CD8+ T cells (P = 0.0002)

Clinically Significant Adverse Events

Serious AE:
Grade 3-4 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
https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/14758

Friedman CF et al. Slide from presentation
https://www.clearityfoundation.org/wp-content/uploads/2020/07/Neo-adj-Nivo-with-CarboPtTax-SGO-2020.pdf

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