Safety and efficacy of nivolumab monotherapy in recurrent or metastatic cervical, vaginal, or vulvar carcinoma: Results from the phase I/II CheckMate 358 trial

Naumann, R. W. et al. (2019) Safety and efficacy of nivolumab monotherapy in recurrent or metastatic cervical, vaginal, or vulvar carcinoma: Results from the phase I/II CheckMate 358 trial. Journal of Clinical Oncology, 37(31), pp. 2825-2834. (doi: 10.1200/JCO.19.00739) (PMID:31487218) (PMCID:PMC6823884)

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Purpose: 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 and Methods: 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. Results: 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. Conclusion: 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.

Item Type:Articles
Additional Information:This study was sponsored by Bristol-Myers Squibb (Princeton, NJ) and ONO Pharmaceutical Co., Ltd. (Osaka, Japan). Professional medical writing assistance was provided by Stefanie Puglielli, PhD, and Meenakshi Subramanian, PhD, CMPP, of Evidence Scientific Solutions Inc, and was funded by Bristol-Myers Squibb. T.M. was supported by the UCH Biomedical Research Centre and the trial was supported by the UCL Experimental Cancer Medicine Centre and the NIRH UCH Clinical Research Facility.
Glasgow Author(s) Enlighten ID:Evans, Professor Jeff
Authors: Naumann, R. W., Hollebecque, A., Meyer, T., Devlin, M.-J., Oaknin, A., Kerger, J., López-Picazo, J. M., Machiels, J.-P., Delord, J.-P., Evans, T. R.J., Boni, V., Calvo, E., Topalian, S. L., Chen, T., Soumaoro, I., Li, B., Gu, J., Zwirtes, R., and Moore, K. N.
College/School:College of Medical Veterinary and Life Sciences > School of Cancer Sciences
Journal Name:Journal of Clinical Oncology
Publisher:American Society of Clinical Oncology
ISSN (Online):1527-7755
Published Online:05 September 2019
Copyright Holders:Copyright © 2019 American Society of Clinical Oncology
First Published:First published in Journal of Clinical Oncology 37(31): 2825-2834
Publisher Policy:Reproduced under a Creative Commons License

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