Durvalumab and Oleclumab in Resectable PDAC

NCT06060405 | Recruiting Phase 2 DMC

• 2 other identifiers: OZUHN-01322-6031
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Percent change in CD8+ cell infiltration

  Baseline biopsy to surgical resection (35 days)

Secondary Outcomes (8)

• 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)

Study Arms (1)

Durvalumab and Oleclumab

EXPERIMENTAL

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

Drug: Durvalumab; Drug: Oleclumab

Interventions

Durvalumab DRUG

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

Also known as: IMFINZI

Durvalumab and Oleclumab

Oleclumab DRUG

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

Also known as: MEDI9447

Durvalumab and Oleclumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Interventions

durvalumab

Study Officials

• Malcolm Moore, MD

  Princess Margaret Cancer Centre/University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Malcolm Moore, MD

CONTACT

416-946-2263; malcolm.moore@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 29, 2023
• Study Start: November 29, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

CA (1)