A Study of Nivolumab in Selected Uterine Cancer Patients

Summary

The purpose of this study is to test the safety of nivolumab and find out what affects, if any, nivolumab has on people and their risk of gynecologic cancer. The investigators also want to find out what effects, good or bad, nivolumab has on the patient and their cancer.

Timeline

Start

2017-08-03

Primary completion

2024-04-01

Completion

2024-04-01

Outcome

Met primary endpoint

paper The ORR was 58.8% (97.5% confidence interval (CI): 40.7-100%), and the PFS24 rate was 64.7% (97.5% one-sided CI: 46.5-100%), meeting the pre-specified endpoints. PMID 38653864 ↗

paper This trial met its co-primary endpoints (ORR and PFS24) early PMID 38653864 ↗

Publications

• Friedman CF, Manning-Geist BL, Zhou Q, Soumerai T, Holland A, Da Cruz Paula A, Green H, Ozsoy MA, Iasonos A, Hollmann T, Leitao MM Jr, Mueller JJ, Makker V, Tew WP, O'Cearbhaill RE, Liu YL, Rubinstein MM, Troso-Sandoval T, Lichtman SM, Schram A, Kyi C, Grisham RN, Causa Andrieu P, Wherry EJ, Aghajanian C, Weigelt B, Hensley ML, Zamarin D. Nivolumab for mismatch-repair-deficient or hypermutated gynecologic cancers: a phase 2 trial with biomarker analyses. Nat Med. 2024 May;30(5):1330-1338. doi: 10.1038/s41591-024-02942-7. Epub 2024 Apr 23.

Drugs

Indications