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VERSATILE-002 is a clinical study combining two medications, PDS0101 and KEYTRUDA® (pembrolizumab), in patients whose head and neck cancer has returned or spread and cannot be removed by surgery.

While exposure to tobacco and alcohol are the most common risk factor for developing head and neck cancer, a large and growing percentage of head and neck cancers are caused by Human Papilloma Virus (HPV) infection. Most HPV-related head and neck cancers are caused by HPV16, which accounts for over 90% of HPV-positive head and neck cancers. 

PDS0101 is a new medication that has shown to stimulate high levels of HPV16-specific killer T-cells. T-cells are a type of white blood cell produced by the body’s immune system. The HPV-specific T-cells developed after treatment with PDS0101 target and kill head and neck cancers that are caused by HPV infection. KEYTRUDA® is an FDA-approved medication for patients whose head and neck cancer has returned or spread and cannot be removed by surgery. This trial will study if combining PDS0101 with KEYTRUDA® is more effective than what has been previously shown with KEYTRUDA® alone. In this study, everyone will receive both PDS0101 and KEYTRUDA®.

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 squamous cell cancer (HNSCC) that is recurrent or metastatic after initial treatment with curative intent
  • Have recovered from complications from previous major surgeries or radiation therapy
  • Have had previous therapies that didn’t work
  • Are in good overall health (determined by examination 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 and/or history of active Hepatitis B or C infection
  • Developed complications from prior anti-cancer therapy

Interested patients should consult with a healthcare professional to see if you meet the entry criteria. 

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 (approximately 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 assessed 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)
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
https://www.cancer.gov/types/head-and-neck

HPV-Related Cancer – National Cancer Institute
https://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-and-cancer

HPV and Oropharyngeal Cancer – Centers for Disease Control and Prevention
https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm

Taking Part in Cancer Treatment Research Studies – National Cancer Institute
https://www.cancer.gov/publications/patient-education/crs.pdf

Support for People with Oral and Head and Neck Cancer
https://www.spohnc.org/

Head and Neck Cancer Alliance
https://www.headandneck.org/

Support for Caregivers of Cancer Patients – National Cancer Institute
https://www.cancer.gov/about-cancer/coping/caregiver-support

 

  SITC Understanding Cancer Immunotherapy 6th Edition

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