Cisplatin + Radiation Therapy vs Durvalumab + Radiation Therapy Followed by Durvalumab vs Durvalumab + Radiation Therapy Followed by Tremelimumab + 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
• Cost-effectiveness of immunotherapy-based treatment arm vs standard of RT and cisplatin in patients with intermediate risk LA-OSC using the EQ-5D-5L
• Number and severity of adverse events
• Cost-utility will be used to abstract indirect costs at the end of RT and at 6 and 12 months post RT
• Lost productivity questionnaire will be used to abstract indirect costs at the end of RT and at 6 and 12 months post RT
• Incidence of second cancer
• PRO-CTCAE baseline, last week of treatment, 3 months, 6 months and 12, 24 and 36 months from the end of RT
• Dysphagia: PSS-HN swallowing subscale at 36 months from the end of RT
• Dysphagia: using MDADI Global at 36 months from the end of RT
• Number and severity of radiation-related late toxicity at 3 months, 6 months and 1 year from the end of RT

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.

As of February 2019, tremelimumab will no longer be tested with new participants joining the study.

View this trial on ClinicalTrials.gov