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

Titre officiel

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

Sommaire:

Le but de cette étude est de déterminer les effets du traitement par le durvalumab sur le cancer. Les chercheurs qui mènent cette étude veulent également évaluer si la prednisone (un type de stéroïde), lorsqu’elle est administrée avec le durvalumab, peut réduire les effets secondaires.

Description de l'essai

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

Voir cet essai sur ClinicalTrials.gov