OncoMatch/Clinical Trials/NCT03847649
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
Is NCT03847649 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Prednisone for cancer.
Treatment: Durvalumab · Prednisone · Prednisone · Tremelimumab — 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)
Check if I qualifyExtracted eligibility criteria
Disease stage
Required: Stage IV
advanced/metastatic/recurrent or unresectable and for which no curative therapy exists
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: immune checkpoint inhibitor (durvalumab, durvalumab in combination with tremelimumab, other anti PD-1/PD-L1 agents, anti CTLA agents)
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
Cannot have received: immune checkpoint inhibitor (anti-PD-(L)1, anti-CTLA-4)
Exception: following discontinuation of immunotherapy for irAE
Patients may not have received subsequent immune checkpoint inhibitors (anti-PD-(L)1 and anti-CTLA-4) following discontinuation of immunotherapy for irAE
Lab requirements
Blood counts
Absolute neutrophils ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 90 g/L
Kidney function
Serum creatinine < 1.25 x ULN or Creatinine clearance ≥ 40 mL/min
Liver function
Bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN (≤ 5.0 x ULN if liver metastases)
Cardiac function
Patients with a significant cardiac history, even if controlled, should have a LVEF ≥ 50%
Absolute neutrophils ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 90 g/L; Bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN (≤ 5.0 x ULN if liver metastases); Serum creatinine < 1.25 x ULN or Creatinine clearance ≥ 40 mL/min; LVEF ≥ 50% if significant cardiac history
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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