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PD-L1 Inhibitor
Durvalumab + Oleclumab for Pancreatic Cancer (DORA Trial)
Phase 2
Recruiting
Led By Malcolm Moore, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Must not have
Active grade 3 or greater edema
Have prior history of myocardial infarction, transient ischemic attack, congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification or stroke within the past 3 months prior to the scheduled first dose of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial evaluates how two drugs can help treat pancreatic cancer before surgery.
Who is the study for?
This trial is for adults with a specific type of pancreatic cancer (PDAC) who are strong enough for surgery, weigh at least 35 kg, and have an expected lifespan of 12 weeks or more. They must not have had recent cancer treatments or certain heart issues, autoimmune diseases, infections like hepatitis or HIV, and can't be on immune-suppressing drugs. Women must avoid pregnancy during the trial.
What is being tested?
The study tests two drugs—Durvalumab and Oleclumab—in patients before they undergo surgery for PDAC. It's conducted across multiple Canadian sites to see how these drugs affect the body's immune response against this type of cancer.
What are the potential side effects?
Possible side effects from Durvalumab and Oleclumab may include reactions related to the immune system affecting various organs, infusion-related reactions similar to allergic responses when receiving the drug through a vein, fatigue, as well as potential impacts on blood cells increasing infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as pancreatic ductal adenocarcinoma.
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I am fully active or can carry out light work.
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I weigh at least 35 kilograms.
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My pancreatic cancer can be surgically removed.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe swelling.
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I have had a heart attack, stroke, or severe heart failure in the last 3 months.
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I do not have any unmanaged ongoing illnesses.
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I have had a severe blood clot in the last 3 months or still have symptoms from any blood clot.
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I have tested positive for HIV or have active tuberculosis.
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I have not had any other cancer besides this one in the last 5 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Durvalumab and OleclumabExperimental Treatment2 Interventions
Durvalumab, 1500 mg x 1 dose and oleclumab 3000 mg x 2 doses every 2 weeks prior to surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 2
~3750
Oleclumab
2015
Completed Phase 2
~880
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,521 Previous Clinical Trials
503,282 Total Patients Enrolled
Malcolm Moore, MDPrincipal InvestigatorPrincess Margaret Cancer Centre/University Health Network
1 Previous Clinical Trials
51 Total Patients Enrolled
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