As reported in the Journal of Clinical Oncology by Naumann et al, the phase I/II CheckMate 358 trial found that nivolumab showed activity in a cohort of patients with recurrent or metastatic cervical, vaginal, or vulvar squamous cell carcinoma.  

“The efficacy of nivolumab in patients with recurrent [or] metastatic cervical and vaginal or vulvar cancers is promising and warrants additional investigation."

— Naumann et al

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Study Details

A total of 24 patients were enrolled in the gynecologic cancer cohort of the multicohort trial, including 19 with cervical carcinoma and 5 with vaginal/vulvar carcinoma. Patients received nivolumab at 240 mg every 2 weeks. Patients with known human papillomavirus (HPV)-negative tumors were not eligible for the trial, but patients with unknown HPV status could be enrolled. Prior systemic therapy for metastatic disease had been received by 79% of patients with cervical cancer and 80% of those with vaginal/vulvar cancer.

The primary endpoint was objective response rate.

Responses

Objective responses were observed in five patients (26.3%) with cervical cancer (including a complete response in three patients with cervical cancer) and in one patient (20%) with vaginal/vulvar cancer. Stable disease was observed in 42.1% of those with cervical cancer and 60.0% of those with vaginal/vulvar cancer. At median follow-up of 19.2 months, the median duration of response was not reached among the five responders with cervical cancer (range = 23.3–29.5+ months), and the response duration was 5.0 months in the one responder with vaginal/vulvar cancer. In the group with cervical cancer, median progression-free survival was 5.1 months and median overall survival was 21.9 months. In the group with vaginal/vulvar cancer, 40% of patients had not experienced disease progression at 6 months, and 40% and 20% were alive at 12 and 18 months, respectively.

Adverse Events

Treatment-related adverse events of any grade were observed in 12 patients (63.2%) with cervical cancer and all 5 patients with vaginal/vulvar cancer. The most common adverse events in the group with cervical cancer were diarrhea (four patients, 21.1%) and fatigue (three patients, 15.8%), and the most common adverse event in the group with vaginal/vulvar cancer was decreased appetite (two patients, 40%). Treatment-related grade 3 or 4 adverse events occurred in four patients in the group with cervical cancer (21.1%); none occurred in the group with vaginal/vulvar cancer. Treatment-related adverse events led to treatment discontinuation in one patient with cervical cancer. No treatment-related deaths were observed. 

The investigators concluded, “The efficacy of nivolumab in patients with recurrent [or] 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.”

Wendel Naumann, MD, of the Levine Cancer Institute, Atrium Health, is the corresponding author of the Journal of Clinical Oncology article.

Disclosure: The study was supported by Bristol-Myers Squibb. For full disclosures of the study authors, visit jco.ascopubs.org.