Head and Neck Cancer (CUE-101 + pembrolizumab)

Head and Neck Cancer (CUE-101 + Pembrolizumab)

Cue Biopharma is evaluating the safety and anti-tumor activity of its lead clinical candidate, CUE-101, in combination with pembrolizumab (KEYTRUDA®) in a Phase 1 open-label, multicenter clinical study for its potential use as a first-line therapy for people with human papilloma virus (HPV16+)-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

The CUE-101 combination trial corresponds to Arm 2 of Cue Biopharma’s broader Phase 1 trial, consisting of a fully enrolled dose escalation portion (Part C) and a fully enrolled expansion portion (Part D) at the recommended Phase 2 dose. Arm 1 of the study is evaluating CUE-101 as a monotherapy as a second line and beyond therapy in the same population.

For more information visit clinicaltrials.gov.

About HPV+ Recurrent or Metastatic Head and Neck Cancer

Human papilloma virus (HPV)-positive cancers account for more than 20,000 deaths each year in the U.S. and Europe1,2.  The majority of these cancers are driven by HPV 16 which carries the E7 antigen targeted by CUE-1013.

Despite treatment with current standards of care, the majority of patients with metastatic disease will experience recurrence, significantly affecting quality of life and often leading to untimely death. Patients with HPV-related head and neck cancers represent an important unmet clinical need and underscore the opportunity for promising new therapeutics.

Patients & Caregivers

Talk to your physician to determine if Cue Biopharma offers a clinical trial that matches your diagnosis, treatment history, and location.

For more information visit clinicaltrials.gov.


  1. US Report: https://hpvcentre.net/statistics/reports/USA.pdf?t=1628865383160
  2. Europe Report: https://hpvcentre.net/statistics/reports/XEX.pdf?t=1628865589343
  3. CUE-101 Data: https://www.who.int/news-room/fact-sheets/detail/human-papillomavirus-(hpv)-and-cervical-cancer