Cisplatin Plus Radiation Therapy vs Durvalumab Plus Radiation Therapy Followed by Durvalumab vs Durvalumab Plus Radiation Therapy Followed by Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Oropharyngeal SCC

Official Title

Randomized Phase II Study of Cisplatin Plus Radiation Therapy Versus Durvalumab Plus Radiation Therapy Followed by Adjuvant Durvalumab Versus Durvalumab Plus Radiation Therapy Followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)

Summary:

Sometimes, cancer patients receive an initial treatment, followed by additional treatment to lower the chance of cancer coming back. The standard or usual treatment for this type of disease is initially having radiation therapy at the same time as chemotherapy (with a drug called cisplatin), with no additional therapy afterwards

Trial Description

Primary Outcome:

  • 3 year event-free survival
Secondary Outcome:
  • Functional Assessment of Cancer Therapy-Head and Neck Version (FACT-HN) score.
  • Local regional failure
  • Distant metastasis-free survival
  • Overall survival
This study is looking at whether a type of drug called durvalumab can be used with radiation during the initial treatment, (instead of cisplatin) and also afterwards as additional therapy. Durvalumab is an immunotherapy drug . It has been tested in many different types of cancers. Durvalumab works by allowing the immune system to detect the cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals. It has been studied in more than 5000 people, approved for use in other cancers and seems promising. 
 This clinical trial will also test another type of immunotherapy drug called tremelimumab, which would also be given as additional treatment. Tremelimumab works in a different way to durvalumab to enhance the immune system reaction against cancer cells and may improve the effect of durvalumab. Tremelimumab may also help slow the growth of the cancer cells or may cause cancer cells to die. It has been shown to shrink tumours in animals. Tremelimumab has been studied in over 1200 people, approved for use in other cancers and seems promising.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society