Scientific publications

Safety and Efficacy of Nivolumab Monotherapy in Recurrent or Metastatic Cervical, Vaginal, or Vulvar Carcinoma: Results From the Phase I/II CheckMate 358 Trial

Sep 5, 2019 | Magazine: Journal of Clinical Oncology

Naumann RW (1), Hollebecque A (2), Meyer T (3), Devlin MJ (3), Oaknin A (4), Kerger J (5), López-Picazo JM (6), Machiels JP (7), Delord JP (8), Evans TRJ (9), Boni V (10), Calvo E (10), Topalian SL (11), Chen T (12), Soumaoro I (12), Li B (12), Gu J (12), Zwirtes R (12), Moore KN (13).

(1) Levine Cancer Institute, Atrium Health, Charlotte, NC.
(2) Gustave Roussy, Villejuif, France.
(3) UCL Cancer Institute, London, United Kingdom.
(4) Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.
(5) Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
(6) Clínica Universidad de Navarra, Navarra, Spain.
(7) Institut Roi Albert II, Service d'Oncologie Médicale, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (IREC, Pole MIRO), UCLouvain, Brussels, Belgium.
(8) IUCT-Oncopole, Toulouse, France.
(9) University of Glasgow, Glasgow, United Kingdom.
(10) START Madrid Centro Integral Oncológico Clara Campal, Madrid, Spain.
(11) Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy and Kimmel Cancer Center, Baltimore, MD.
(12) Bristol-Myers Squibb, Princeton, NJ.
(13) Stephenson Cancer Center at the University of Oklahoma, Oklahoma City, OK, and Sarah Cannon Research Institute, Nashville, TN.


Nivolumab was assessed in patients with virus-associated tumors in the phase I/II CheckMate 358 trial ( identifier: NCT02488759). We report on patients with recurrent/metastatic cervical, vaginal, or vulvar cancers.


Patients received nivolumab 240 mg every 2 weeks. Although patients with unknown human papillomavirus status were enrolled, patients known to have human papillomavirus-negative tumors were ineligible. The primary end point was objective response rate. Duration of response (DOR), progression-free survival, and overall survival were secondary end points. Safety and patient-reported outcomes were exploratory end points.


Twenty-four patients (cervical, n = 19; vaginal/vulvar, n = 5) were enrolled. Most patients had received prior systemic therapy for metastatic disease (cervical, 78.9%; vaginal/vulvar, 80.0%). Objective response rates were 26.3% (95% CI, 9.1 to 51.2) for cervical cancer and 20.0% (95% CI, 0.5 to 71.6) for vaginal/vulvar cancers. At a median follow-up of 19.2 months, median DOR was not reached (range, 23.3 to 29.5+ months; + indicates a censored observation) in the five responding patients in the cervical cohort; the DOR was 5.0 months in the single responding patient in the vaginal/vulvar cohort. Median overall survival was 21.9 months (95% CI, 15.1 months to not reached) among patients with cervical cancer. Any-grade treatment-related adverse events were reported in 12 of 19 patients (63.2%) in the cervical cohort and all five patients in the vaginal/vulvar cohort; there were no treatment-related deaths. In the cervical cohort, nivolumab treatment generally resulted in stabilization of patient-reported outcomes associated with health status and health-related quality of life.


The efficacy of nivolumab in patients with recurrent/metastatic cervical and vaginal or vulvar cancers is promising and warrants additional investigation. No new safety signals were identified with nivolumab treatment in this population.

CITATION  J Clin Oncol. 2019 Sep 5:JCO1900739. doi: 10.1200/JCO.19.00739.