The following article features coverage from the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Nivolumab, a programmed death (PD)-1 inhibitor, showed promising clinical activity in recurrent or metastatic cervical cancers and provides a promising new approach to treatment, according to data from the CheckMate 358 trial ( Identifier: NCT02488759) reported at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.1

After first-line therapy, options are limited for women with gynecologic tumors (cervical, vaginal, and vulvar). The expression of PD-1 and its ligand PD-L1 in these tumors provided a rationale for testing nivolumab in this setting.

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CheckMate 358 is an ongoing study evaluating the efficacy of nivolumab alone or in combination across 5 virus-associated cancers.

Antoine Hollebecque, MD, of the Gustave Roussy Cancer Institute in Villejuif, France, presented data for the cohort of 24 patients — 19 patients had cervical cancer and 5 had vaginal or vulvar cancers. Patients received nivolumab 240 mg every 2 weeks until disease progression or unacceptable toxicity.

Patients had an Eastern Cooperative Oncology Group Performance (ECOG) Status of 0 or 1 and had received at least 2 prior systemic therapies.

At a median follow up of 31 weeks, for the primary endpoint, the objective response rate (ORR) was 20.8% of patients (1/24 showed a complete response [CR]; 4/24 showed a partial response [PR]). The disease control rate was 70.8%.

The ORR for cervical cancer was 26.3% and the DCR was 80%. Responses were seen in patients who had not received prior systemic therapy (28.6%) as well as 1 or more prior systemic therapies (17.6%). 

Responses were not dependent on PD-L1 expression or on HPV status, which is associated with at least 90% of all cervical cancers.

Median overall survival was not reached.

Treatment-related adverse events of any grade were reported for 70.8% of patients, and grade 3 to 4 events were seen in 12.5% of patients.

RELATED: Cervical Cancer Progression More Likely With HIV Infection

“The observed safety profile of nivolumab was manageable and consistent with previous results seen with nivolumab monotherapy in other tumors. These data support further evaluation in these patients, including in combination with other therapies,” Dr Hollebecque concluded.  

Read more of Cancer Therapy Advisor‘s coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.


  1. Hollebecque A, Meyer T, Moore KN, et al. 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. J Clin Oncol. 2017;34(suppl; abstr 5504).