A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior
I238A: 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. I238B: The purpose of this study is to allow patients prev
| Condition(s) | Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | I238A: 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. I238B: The purpose of this study is to allow patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab) |
| Who can participate | Substudy A: Inclusion Criteria: * Patients must have histologically and/or cytologically confirmed solid tumour, that is advanced/ metastatic/recurrent or unresectable and for which no curative therapy exists. * Patients must live within Canada and have received durvalumab alone, or durvalumab in combination with tremelimumab, with or without chemotherapy/targeted therapy. Patients who have received other anti PD-1/PD-L1 agents +/- anti CTLA agents are eligible, providing full details of prior therapy, toxicity and management are available. Consult with CCTG for further details. * Patients must have previously discontinued immunotherapy due to an irAE. * Immune-related adverse events must have resolved to ≤ grade 1 or baseline and patient must have completed corticosteroid therapy at least |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Canadian Cancer Trials Group |
| Locations | Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Saint John, New Brunswick, Canada; Hamilton, Ontario, Canada; Kitchener, Ontario, Canada (+6 more sites) |
| Start date | 2020-03-09 |
| NCT ID | NCT03847649 |
| Official listing | https://clinicaltrials.gov/study/NCT03847649 |