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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline biopsy to surgical resection (35 days)

Awards & highlights

DORA Trial 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.Check my eligibility

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.See study design

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.

DORA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

DORA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline biopsy to surgical resection (35 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline biopsy to surgical resection (35 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline biopsy to surgical resection (35 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change in CD8+ cell infiltration

Secondary outcome measures

Percent change in CD3 cell population in blood

Percent change in CD3 cell population in tumour tissue

Percent change in CD45RA cell population in blood

+5 more

DORA 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

~3870

Oleclumab

2015

Completed Phase 2

~880

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,158 Total Patients Enrolled

Malcolm Moore, MDPrincipal InvestigatorPrincess Margaret Cancer Centre/University Health Network

1 Previous Clinical Trials

51 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there a hazard associated with Durvalumab and Oleclumab treatment?

"Durvalumab and Oleclumab received a score of 2, as Phase 2 trials have yet to demonstrate the efficacy of this combination therapy despite providing evidence for safety."

Answered by AI

Is the patient enrollment period still open for this investigation?

"As stated on clinicaltrials.gov, the current state of this trial does not involve patient recruitment at present. Although it was posted on October 30th 2023 and updated as recently as September 22nd 2023, 823 other medical studies are actively looking for participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Durvalumab and Oleclumab in Resectable PDAC

2023. "Durvalumab and Oleclumab in Resectable PDAC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06060405.