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New treatment option for Pancreatic Ductal Adenocarcinoma
Official title Durvalumab and Oleclumab in Resectable PDAC
ClinicalTrials.gov ID: NCT06060405
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, being studied as a potential treatment for pancreatic ductal adenocarcinoma.
Also referred to as IMFINZI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Receipt of any conventional or investigational anticancer therapy within 21 days or palliative radiotherapy within 14 days prior to the scheduled...
- 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...
- 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...
- Active or prior documented autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment with the following...
See the full eligibility criteria
- 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
- 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...
- 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...
- Active or prior documented autoimmune disorders within the past 3 years prior to the scheduled first dose of study treatment with the following exceptions
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.