Pancreatic Ductal AdenocarcinomaPhase 2DORANCT06060405
Durvalumab and Oleclumab in Resectable PDAC
A Phase 2 study testing Durvalumab and Oleclumab in people with Pancreatic Ductal Adenocarcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a multi-site Canadian, window of opportunity study to evaluate the immune activity of durvalumab and oleclumab in resectable pancreatic ductal adenocarcinoma (PDAC) when given prior to surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Durvalumab and Oleclumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- 29 Nov 2023to 30 Oct 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Weight ≥ 35 kg
- Have a life expectancy ≥ 12 weeks
- Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Upfront resectable PDAC
- Have adequate organ and marrow function required for the study
- Baseline images taken prior to treatment must undergo central review
- Participants must agree to use study approved methods to prevent pregnancy for study required period
Who cannot join
- Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment
- Prior receipt of any immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1 including durvalumab antibodies and agents targeting CD73, CD39, or adenosine receptors, excluding therapeutic anticancer vaccines.
- Concurrent enrolment in another therapeutic clinical study. Enrolment in observational studies will be allowed.
- Have a history of Grade 3 or greater thromboembolic events in the prior 3 months or thromboembolic event of any grade with ongoing symptoms.
- 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.
- Active or prior documented autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment with the following exceptions
Show all 24Show fewer
- Vitiligo or alopecia
- Hypothyroidism not requiring systemic treatment or stable on hormone replacement
- Psoriasis not requiring systemic treatment
- Any chronic skin condition that does not require systemic therapy
- Have known active hepatitis infection. Participants with a past or resolved Hepatitis B (HBV) infection are eligible. Participants positive for Hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection
- Other invasive malignancy within 5 years.
- Known allergy or hypersensitivity to investigational product formulations.
- Active grade 3 or greater edema
- Uncontrolled intercurrent illness
- Current or prior use of immunosuppressive medication within 14 days prior to the scheduled first dose of study treatment with the following exceptions:
- Intranasal, topical, inhaled corticosteroids or local steroid injections
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
- Steroids as premedication for hypersensitivity reaction
- Receipt of live, attenuated vaccine within 30 days prior to the scheduled first dose of study treatment
- Major surgery within 28 days prior to scheduled first dose of study treatment or still recovering from prior surgery. Local are allowed, without needing to wait for the 28 day recovery period.
- Are pregnant, lactating, or intend to become pregnant during their participation in the study
- Any condition that, in the opinion of the investigator, would interfere with safe administration or evaluation of the investigational products or interpretation of subject safety or study results
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Malcolm Moore, MD
Malcolm Moore, MD
About this study
Official title: Durvalumab and Oleclumab in Resectable PDAC: A Window of Opportunity Study (DORA Trial)
This is a multi-site Canadian, window of opportunity study to evaluate the immune activity of durvalumab and oleclumab in resectable pancreatic ductal adenocarcinoma (PDAC) when given prior to surgery.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- Durvalumab, Oleclumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called IMFINZI
Durvalumab is a monoclonal antibody that blocks the interaction of PD-L1 with PD-1 on immune cells.
OleclumabDrug
Also called MEDI9447
Oleclumab is a monoclonal antibody that binds to and inhibits the activity of CD73.
| Study group | Role | What they receive |
|---|---|---|
| Durvalumab and Oleclumab | Experimental | Durvalumab, 1500 mg x 1 dose and oleclumab 3000 mg x 2 doses every 2 weeks prior to surgical resection. Receives: Drug: Durvalumab; Drug: Oleclumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in CD8+ cell infiltration
Measured: Baseline biopsy to surgical resection (35 days)
Secondary outcomes (8)
Percent change in CD3 cell population in tumour tissue
Measured: Baseline biopsy to surgical resection (35 days)
Percent change in CD3 cell population in blood
Measured: Baseline biopsy to surgical resection (35 days)
Percent change in CD45RA cell population in tumour tissue
Measured: Baseline biopsy to surgical resection (35 days)
Percent change in CD45RA cell population in blood
Measured: Baseline biopsy to surgical resection (35 days)
Percent change in RO T cell population in tumour tissue
Measured: Baseline biopsy to surgical resection (35 days)
Percent change in RO T cell population in blood
Measured: Baseline biopsy to surgical resection (35 days)
Percent change in M1 vs M2 macrophage population in tumour tissue
Measured: Baseline biopsy to surgical resection (35 days)
Percent change in M1 vs M2 macrophage population in blood
Measured: Baseline biopsy to surgical resection (35 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start29 Nov 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malcolm Moore, MD, Principal investigator, Princess Margaret Cancer Centre/University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060405
- Sponsor's protocol ID
- OZUHN-013
- Other IDs
- 22-6031
- Acronym
- DORA
- Status last verified
- Jun 2026
- First submitted
- 22 Sep 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durvalumab and Oleclumab in Resectable PDAC: A Window of Opportunity Study (DORA Trial)
- ClinicalTrials.gov ID
- NCT06060405
- Acronym / sponsor ID
- DORA / OZUHN-013
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-site Canadian, window of opportunity study to evaluate the immune activity of durvalumab and oleclumab in resectable pancreatic ductal adenocarcinoma (PDAC) when given prior to surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Durvalumab and Oleclumab | Experimental | Drug: Durvalumab, Drug: OleclumabDurvalumab, 1500 mg x 1 dose and oleclumab 3000 mg x 2 doses every 2 weeks prior to surgical resection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Weight ≥ 35 kg
- Have a life expectancy ≥ 12 weeks
- Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Upfront resectable PDAC
Key exclusion criteria (24 listed)
- Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled first dose of study treatment
- Prior receipt of any immune-mediated therapy including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1 including durvalumab antibodies and agents targeting CD73, CD39, or adenosine receptors, excluding therapeutic anticancer vaccines.
- Concurrent enrolment in another therapeutic clinical study. Enrolment in observational studies will be allowed.
- Have a history of Grade 3 or greater thromboembolic events in the prior 3 months or thromboembolic event of any grade with ongoing symptoms.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: IMFINZIDurvalumab is a monoclonal antibody that blocks the interaction of PD-L1 with PD-1 on immune cells. | Drug | Durvalumab and Oleclumab |
| OleclumabAlso: MEDI9447Oleclumab is a monoclonal antibody that binds to and inhibits the activity of CD73. | Drug | Durvalumab and Oleclumab |
Primary outcome
Percent change in CD8+ cell infiltration
Time frame: Baseline biopsy to surgical resection (35 days)
8 secondary outcomes
Percent change in CD3 cell population in tumour tissue
Time frame: Baseline biopsy to surgical resection (35 days)
Percent change in CD3 cell population in blood
Time frame: Baseline biopsy to surgical resection (35 days)
Percent change in CD45RA cell population in tumour tissue
Time frame: Baseline biopsy to surgical resection (35 days)
Percent change in CD45RA cell population in blood
Time frame: Baseline biopsy to surgical resection (35 days)
Percent change in RO T cell population in tumour tissue
Time frame: Baseline biopsy to surgical resection (35 days)
Percent change in RO T cell population in blood
Time frame: Baseline biopsy to surgical resection (35 days)
Percent change in M1 vs M2 macrophage population in tumour tissue
Time frame: Baseline biopsy to surgical resection (35 days)
Percent change in M1 vs M2 macrophage population in blood
Time frame: Baseline biopsy to surgical resection (35 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Malcolm Moore, MD principal investigator
Princess Margaret Cancer Centre/University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab and Oleclumab in people with Pancreatic Ductal Adenocarcinoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malcolm Moore, MD (416-946-2263, malcolm.moore@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in CD8+ cell infiltration (time frame: Baseline biopsy to surgical resection (35 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.