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).


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.