Wednesday, June 12, 2019 IND238 (NCT03847649), A Phase II Study of Durvalumab Retreatment in Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity, has been centrally activated. 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. Primary: To determine the safety and toxicity profile of rechallenging with durvalumab at the time of disease progression, in patients who previously discontinued immunotherapy due to irAE. Secondary: To determine the objective response rate (RECIST 1.1 and iRECIST); To evaluate the efficacy of corticosteroids in preventing recurrent or new grade 2 or higher irAEs. Tertiary: To explore PFS and iPFS on rechallenge with durvalumab after progression on initial immunotherapy; To explore blood-based and stool-based biomarkers for irAEs; PD-L1 expression. Find out more on the IND238 CCTG trial page.
