Durvalumab and Oleclumab in Resectable PDAC
ConditionPancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Durvalumab
DrugDurvalumab is a monoclonal antibody that blocks the interaction of PD-L1 with PD-1 on immune cells.
Oleclumab
DrugOleclumab is a monoclonal antibody that binds to and inhibits the activity of CD73.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Durvalumab and OleclumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Percent change in CD8+ cell infiltration
Time frame
Baseline biopsy to surgical resection (35 days)Secondary outcomes
1
Percent change in CD3 cell population in tumour tissue
Time frame
Baseline biopsy to surgical resection (35 days)2
Percent change in CD3 cell population in blood
Time frame
Baseline biopsy to surgical resection (35 days)3
Percent change in CD45RA cell population in tumour tissue
Time frame
Baseline biopsy to surgical resection (35 days)4
Percent change in CD45RA cell population in blood
Time frame
Baseline biopsy to surgical resection (35 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov