An open-label, multicohort, phase I/II study of nivolumab in patients with virus-associated tumors (CheckMate 358): Efficacy and safety in recurrent or metastatic (R/M) cervical, vaginal, and vulvar cancers.

• DOI: 10.1200/jco.2017.35.15_suppl.5504
• Publication Date: 2018-09-06T15:46:45Z
• Authors: Antoine Hollebecque; Tim Meyer; Kathleen N. Moore; Jean-Pascal H. Ma...; Jacques De Greve; José María López-...; Ana Oaknin; Joseph N. Kerger; Valentina Boni; T.R. Jeffry Evans; Rebecca Sophie Kr...; Shangbang Rao; Ibrahima Soumaoro; Z. Alexander Cao; Suzanne Louise To...
• Keywords: Progression-free survival

5504 Background: Treatment options for cervical, vaginal, and vulvar (GYN) cancers are limited after first-line therapy. Human papillomavirus (HPV) infection is associated with squamous cell carcinomas of the cervix (≥90%) vulva/vagina (40–70%), may elicit an immune reaction. Programmed death (PD)-1 its major ligand PD-L1 expressed in GYN inhibit responses. Nivolumab disrupts PD-1–mediated signaling, restoring antitumor immunity. Methods: In CheckMate 358 (NCT02488759), ongoing multicohort study 5 virus-associated cancers, PD-L1–unselected adults R/M ECOG PS 0–1, ≤2 prior systemic therapies disease were eligible to receive nivolumab 240 mg every 2 weeks until progression or unacceptable toxicity. Primary endpoints objective response rate (ORR) safety; secondary duration (DoR), progression-free survival (PFS), overall (OS). Results: Of 24 treated patients (pts), 19 had cervical vaginal cancer; median age was 51 y. At a follow-up 31 wks (range: 6–38), ORR 20.8% (Table), control (ORR + SD) 70.8%. All responses pts cancer (ORR, 26.3%) observed regardless HPV status number therapies. Median PFS 5.5 mo (95% CI: 3.5, NR); OS NR. Conclusions: demonstrated encouraging clinical activity manageable safety profile supporting further evaluation these pts. Updated biomarker data be presented. Clinical trial information: NCT02488759. [Table: see text]