RecruitingPhase 2NCT03847649

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


Sponsor

Canadian Cancer Trials Group

Enrollment

60 participants

Start Date

Mar 9, 2020

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Durvalumab, a drug called Prednisone, and others for people with cancer. The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

1500 mg IV, 60 min, Day 1 every 4 weeks

DRUGPrednisone

0.5mg/kg; PO, Daily cycles 1 \& 2

DRUGPrednisone

10mg, PO, Daily cycles 1 \& 2

DRUGTremelimumab

Patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab)


Locations(11)

Cross Cancer Institute

Edmonton, Alberta, Canada

BCCA - Kelowna

Kelowna, British Columbia, Canada

BCCA - Vancouver

Vancouver, British Columbia, Canada

Regional Health Authority B, Zone 2

Saint John, New Brunswick, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Waterloo Regional Health Network (WRHN)

Kitchener, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

Windsor Regional Cancer Centre

Windsor, Ontario, Canada

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

View Full Details on ClinicalTrials.gov

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NCT03847649


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