drugset / Trial / 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

NCT03847649

Phase 2 Recruiting 60 enrolled Canadian Cancer Trials Group AstraZeneca · collab
RandomizedFactorialOpen-labelTreatment

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)

Timeline

Start
2020-03-09
Primary completion
2030-04-30
Completion
2031-04-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Durvalumab Monoclonal antibody 1500 mg Intravenous
Comparator Prednisone Other / unclassified 0.5 mg/kg Oral
Comparator Prednisone Other / unclassified 10 mg Oral
Comparator Tremelimumab Monoclonal antibody

Indications