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Attend this session at the
2017 ASCO Annual Meeting!

Session: Gynecologic Cancer

Type: Oral Abstract Session

Time: Friday June 2, 3:00 PM to 6:00 PM

Location: S406

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.

Cervical Cancer

Gynecologic Cancer

2017 ASCO Annual Meeting

Abstract No:

J Clin Oncol 35, 2017 (suppl; abstr 5504)

Author(s): Antoine Hollebecque, Tim Meyer, Kathleen N. Moore, Jean-Pascal H. Machiels, Jacques De Greve, José María López-Picazo, Ana Oaknin, Joseph N. Kerger, Valentina Boni, T.R. Jeffry Evans, Rebecca Sophie Kristeleit, Shangbang Rao, Ibrahima Soumaoro, Z. Alexander Cao, Suzanne Louise Topalian; Gustave Roussy Cancer Institute, Villejuif, France; University College London Cancer Institute, London, United Kingdom; University of Oklahoma Health Sciences Center, Oklahoma City, OK; Cliniques Universitaires Saint-Luc, Brussels, Belgium; Vrije Universiteit Brussel (VUB), Brussels, Belgium; University Clinic of Navarra, Pamplona, Spain; Vall d’Hebron University Hospital Institute of Oncology (VHIO), Barcelona, Spain; Institut Jules Bordet, Brussels, Belgium; START Madrid-CIOCC Hospital Universitario HM Sanchinarro, Madrid, Spain; University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; Bristol-Myers Squibb, Princeton, NJ; The Sidney Kimmel Comprehensive Cancer Center and Bloomberg-Kimmel Institute for Cancer Immunotherapy at Johns Hopkins, Baltimore, MD

Abstract Disclosures


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

Response and safety.

Response-evaluable pts (N = 24)Prior systemic R/M therapies
(n = 7)
(n = 17)
Best overall response, n (%)
Complete response1 (4.2)01 (5.9)
Partial response4 (16.7)2 (28.6)2 (11.8)
Stable disease (SD)12 (50.0)3 (42.9)9 (52.9)
Progressive disease7 (29.2)2 (28.6)5 (29.4)
ORR, % (95% CI)20.8 (7, 42)28.6 (4, 71)17.6 (4, 43)
Time to response, median (range), mo5.3 (1.9, 7.1)
DoR, median, moNR
Treatment-related adverse events, %
Any grade70.8
Grade 3–412.5

NR = not reached.

Other Abstracts in this Sub-Category:


1. Pembrolizumab for previously treated advanced cervical squamous cell cancer: Preliminary results from the phase 2 KEYNOTE-158 study.

Meeting: 2017 ASCO Annual Meeting Abstract No: 5514 First Author: Jan H.M. Schellens
Category: Gynecologic Cancer - Cervical Cancer


2. Association of T cell responses after vaccination with HPV16 long peptides for late stage cervical cancer with prolonged survival.

Meeting: 2017 ASCO Annual Meeting Abstract No: 5525 First Author: Winald R. Gerritsen
Category: Gynecologic Cancer - Cervical Cancer


3. A phase I study of sequential ipilimumab in the definitive treatment of node positive cervical cancer: GOG 9929.

Meeting: 2017 ASCO Annual Meeting Abstract No: 5526 First Author: Jyoti Mayadev
Category: Gynecologic Cancer - Cervical Cancer