The following article features coverage from the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain. Click here to read more of Cancer Therapy Advisor’s conference coverage.

Immune checkpoint inhibition may improve the efficacy of vaccine-induced T cells in incurable human papilloma virus (HPV) genotype 16–positive cancer, according to data presented at the European Society of Medical Oncology (ESMO) 2017 Congress in Spain.

Anticancer vaccines have not successfully treated HPV-16–positive cancer to date. This trial tested the hypothesis that immune checkpoint inhibition may promote the efficacy of vaccine-induced T cells.

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The phase 2 trial treated 24 patients with HPV-16–positive oropharynx cancer (OPC; 22 patients), anal cancer (1 patient), or cervical cancer (1 patient) with the HPV-16 vaccine ISA 101 plus nivolumab. Among the patients, 75% had experienced progression within 6 months of prior platinum-therapy and 50% had received prior cetuximab.

The primary endpoint was objective response rate (ORR) targeting 30% and the secondary endpoints included progression-free survival (PFS), overall survival (OS), and tolerability.

The trial met its primary endpoint, with an ORR of 33% among the entire cohort and 36% among patients with OPC. The overall ORR included 1 complete response, 7 partial responses, 3 stable disease, and 13 progressive disease. The median duration of response was 30.1+ weeks.

The median PFS was 2.7 months (95% CI, 2.3-8.0 months) with a 6-month PFS rate of 33% (95% CI, 16-52%). The 6-month OS was 74% (95% CI, 51-87%) and the median OS was not yet reached.

Adverse events included elevated transaminase and lipase, fever, injection site reactions, fatigue, and nausea.

RELATED: Nivolumab Approved for Metastatic Colorectal Cancer

These data suggest that nivolumab augments the efficacy of a HPV-16 vaccine among patients with HPV-16–positive cancer. According to the investigators, these findings warrant a larger, randomized clinical trial.

Read more of Cancer Therapy Advisor‘s coverage of the European Society of Medical Oncology (ESMO) 2017 Congress by visiting the conference page.


  1. Glisson B, Massarelli E, William WN, et al. Nivolumab and ISA 101 HPV vaccine in incurable HPV-16+ cancer. Presented at: 2017 ESMO Congress; Madrid, Spain: September 8-12, 2017. Abstract 1136O.