A Phase II Study of Durvalumab of Patients Previously Enrolled to Completed CCTG Studies

Official Title

A Phase II Study of Durvalumab Treatment Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

Summary:

The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects.

Trial Description

Primary Outcome:

• Substudy A: Number and severity of adverse events
• Substudy B: To facilitate continued treatment with durvalumab (+/- Tremelimumab) for patients currently enrolled on completed CCTG trials
• Substudy B: Number and severity of adverse events

Secondary Outcome:

• Substudy A:Objective response rate RECIST 1.1
• Substudy A: Objective response rate iRECIST
• Substudy A: Efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs as estimated by the percentages of patients who received corticosteroids and developed recurrent or new grade 2 or higher irAEs

Durvalumab is a new type of drug for many types of cancer. Durvalumab is an immunotherapy drug and not a chemotherapy drug. Laboratory tests show that it works by allowing the immune system (PD-1 and PD-L1 interaction) to detect your cancer and reactivating 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 and has been studied in more than 6000 people. This drug seems promising but it is not clear if it can offer better results than standard treatment alone or if people can be re-treated with durvalumab after previous side effects

View this trial on ClinicalTrials.gov