Testing Durvalumab with Oleclumab for pancreatic ductal adenocarcinoma

Exclusion

• −Known allergy or hypersensitivity to investigational product formulations.
• −Steroids as premedication for hypersensitivity reaction
• −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
• −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 enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in another therapeutic clinical study. Enrolment in observationalObservational studyA study that watches what happens without assigning any treatment.Read more → 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
• −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
• −Other invasive malignancy within 5 years.
• −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
• −Receipt of live, attenuated vaccine within 30 days prior to the scheduled first dose of study treatment
• −Any condition that, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would interfere with safe administration or evaluation of the investigational products or interpretation of subject safety or study results
• −Are pregnant, lactating, or intend to become pregnant during their participation in the study
• −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.