VERSATILE-002 is a clinical study for patients whose head and neck cancer has returned or spread. Patients who enroll in VERSATILE-002 will receive two drugs: PDS0101 and KEYTRUDA®.

KEYTRUDA® is an approved drug for patients whose head and neck cancer has returned or spread. PDS0101 is an investigational medicine targeting human papillomavirus (HPV). PDS0101 has been shown to attack HPV-related cancer.

VERSATILE-002 will study if combining PDS0101 with KEYTRUDA® is more effective than using KEYTRUDA® alone. In this study, all patients who choose to enroll will receive both drugs. There is no placebo.

Many head and neck cancers are caused by HPV infection. Most HPV-related head and neck cancers are caused by HPV16. PDS0101 has been shown to stimulate high levels of HPV16-specific killer T-cells that target and kill head and neck cancers that are caused by HPV infection.

Who is Eligible?

You may be able to enroll in the VERSATILE-002 study if you:

  • Are an adult who has HPV16 positive head and neck cancer that has come back or spread
  • Have recovered from complications from previous major surgeries or radiation therapy
  • Are in good overall health (determined by an exam and blood work) 
Who is not Eligible?

You may be excluded from enrolling in the VERSATILE-002 study if you:

  • Are pregnant
  • Have active cancer that has spread to the brain
  • Have HIV infection
  • Developed complications from prior anti-cancer therapy

Interested patients should talk to their doctor to see if they qualify.

What Will Happen During the Study?

If you qualify for and decide to participate in the VERSATILE-002 study:

  • You will undergo screening tests
  • You will receive KEYTRUDA® treatment every 3 weeks for up to 35 treatments (~2 years)
  • PDS0101 will be given in combination with KEYTRUDA® during the first four cycles of treatment and again during cycle 12.
  • Both medicines are given by injection
  • You will have blood work done before each treatment
  • You will have imaging studies every 9 weeks for the first year to evaluate the status of your cancer; after the first year, you will be checked every 12 weeks
  • You will receive treatment until either the cancer worsens, or you’ve received 35 treatments (the maximum number given in the study)

Learn More

Where is the treatment available?

The VERSATILE-002 study is currently being conducted at approximately 27 leading cancer sites throughout the United States. Click the map below to find a study site near you:



Not yet recruiting  Recruiting


For More Information About Head and Neck Cancers

Head and Neck Cancer – National Cancer Institute

HPV-Related Cancer – National Cancer Institute

HPV and Oropharyngeal Cancer – Centers for Disease Control and Prevention

Taking Part in Cancer Treatment Research Studies – National Cancer Institute

Support for People with Oral and Head and Neck Cancer

Head and Neck Cancer Alliance

Support for Caregivers of Cancer Patients – National Cancer Institute


  SITC Understanding Cancer Immunotherapy 6th Edition

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