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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Durvalumab	1500 mg IV, 60 min, Day 1 every 4 weeks
DRUG	Prednisone	0.5mg/kg; PO, Daily cycles 1 \& 2
DRUG	Prednisone	10mg, PO, Daily cycles 1 \& 2
DRUG	Tremelimumab	Patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab)

Timeline

• Start date: 2020-03-09
• Primary completion: 2030-04-30
• Completion: 2031-04-30
• First posted: 2019-02-20
• Last updated: 2025-06-11

Locations

12 sites across 1 country: Canada