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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-06-11

No results posted yet for this study

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)

Conditions

Interventions

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)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Peter Ellis · Juravinski Cancer Centre at Hamilton Health Sciences Centre, Hamilton, ON Canada

  • Sara K Taylor · BCCA-Cancer Centre for the Southern Interior, Kelowna, BC Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03847649 on ClinicalTrials.gov