Durvalumab And Oleclumab In Resectable PDAC

Study Overview

Durvalumab and Oleclumab in Resectable PDAC

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.

N/A

Pancreatic Ductal Adenocarcinoma

DRUG: Durvalumab
DRUG: Oleclumab

OZUHN-013
22-6031 (OTHER Identifier) (OTHER: University Health Network)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2023-09-22	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-01-05
First Submitted that Met QC Criteria 2023-09-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-01-08
First Posted (ACTUAL) 2023-09-29	Results First Posted N/A	Last Verified 2024-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Durvalumab and Oleclumab Durvalumab, 1500 mg x 1 dose and oleclumab 3000 mg x 2 doses every 2 weeks prior to surgical resection.	DRUG: Durvalumab Durvalumab is a monoclonal antibody that blocks the interaction of PD-L1 with PD-1 on immune cells. DRUG: Oleclumab Oleclumab is a monoclonal antibody that binds to and inhibits the activity of CD73.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Durvalumab and Oleclumab

Durvalumab, 1500 mg x 1 dose and oleclumab 3000 mg x 2 doses every 2 weeks prior to surgical resection.

DRUG: Durvalumab

Durvalumab is a monoclonal antibody that blocks the interaction of PD-L1 with PD-1 on immune cells.

DRUG: Oleclumab

Oleclumab is a monoclonal antibody that binds to and inhibits the activity of CD73.

Primary Outcome Measures	Measure Description	Time Frame
Percent change in CD8+ cell infiltration		Baseline biopsy to surgical resection (35 days)

Secondary Outcome Measures	Measure Description	Time Frame
Percent change in CD3 cell population in tumour tissue		Baseline biopsy to surgical resection (35 days)
Percent change in CD3 cell population in blood		Baseline biopsy to surgical resection (35 days)
Percent change in CD45RA cell population in tumour tissue		Baseline biopsy to surgical resection (35 days)
Percent change in CD45RA cell population in blood		Baseline biopsy to surgical resection (35 days)
Percent change in RO T cell population in tumour tissue		Baseline biopsy to surgical resection (35 days)
Percent change in RO T cell population in blood		Baseline biopsy to surgical resection (35 days)
Percent change in M1 vs M2 macrophage population in tumour tissue		Baseline biopsy to surgical resection (35 days)
Percent change in M1 vs M2 macrophage population in blood		Baseline biopsy to surgical resection (35 days)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Malcolm Moore, MD

Phone Number: 416-946-2263

Email: malcolm.moore@uhn.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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 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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Malcolm Moore, MD, Princess Margaret Cancer Centre/University Health Network

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record

Study Overview

Study Record Dates

Study Plan

Design Details

Contacts and Locations

Participation Criteria

Collaborators and Investigators

Publications

Treat yourself

Let Us Take Care Of You

About

Events

Fundraising

Contact Us

Learn

Resources

Patients

Caregivers

Learn

Resources

PatientS

Caregivers

Clinical Trial Record