Phase II Study Evaluating Durvalumab Treatment for Adults with Advanced Solid Tumors Who Stopped Prior Immunotherapy Including Continued Durvalumab - Tremelimumab for Previous Trial Participants

What this Trial Is About

Researchers are evaluating the effects of durvalumab, an immunotherapy drug, on various advanced solid tumors in adults who previously stopped prior immunotherapy due to immune-related side effects. This phase II study also investigates whether prednisone, a steroid, can reduce side effects when given with durvalumab. Additionally, the study allows patients from completed Canadian Cancer Trials Group CCTG studies to continue treatment with durvalumab with or without tremelimumab. Participants receive durvalumab at a dose of 1500 mg intravenously every 4 weeks. Prednisone may be given orally in the first two cycles at specific doses to manage side effects. Patients previously enrolled in other CCTG trials may continue durvalumab treatment, sometimes combined with tremelimumab. The study uses a factorial design and randomized allocation to evaluate these treatments over a period of up to two years. Participants undergo screening and regular follow-ups to monitor side effects and treatment response. Assessments include laboratory tests, imaging to document disease status, and evaluation of immune-related adverse events. Researchers measure the number and severity of side effects and the effectiveness of corticosteroids in preventing recurrent immune-related events. The study also collects tumor samples for correlative studies. Treatment begins promptly after enrollment, and patients are followed for up to two years to assess safety and continued treatment outcomes.

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