Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06060405

Durvalumab and Oleclumab in Resectable PDAC

Led by University Health Network, Toronto · Updated on 2024-01-08

22

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Durvalumab and Oleclumab in Resectable PDAC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Weight 63 35 kg
  • Have a life expectancy 63 12 weeks
  • Confirmed histological or cytological diagnosis of pancreatic ductal adenocarcinoma (PDAC)
  • Tumor must be upfront resectable PDAC
  • Adequate organ and marrow function for study participation
  • Baseline images taken prior to treatment must undergo central review
  • Agree to use study-approved pregnancy prevention methods during the study period
Not Eligible

You will not qualify if you...

  • Received any conventional or investigational anticancer therapy within 21 days prior to first study dose or palliative radiotherapy within 14 days prior
  • Prior treatment with immune-mediated therapies including anti CTLA-4, anti-PD-1, anti-PD-L1 including durvalumab, or agents targeting CD73, CD39, or adenosine receptors (except therapeutic anticancer vaccines)
  • Enrolled in another therapeutic clinical study (observational studies allowed)
  • History of Grade 3 or higher thromboembolic events in the past 3 months or any thromboembolic event with ongoing symptoms
  • History of myocardial infarction, transient ischemic attack, congestive heart failure Class 3 or higher, or stroke within past 3 months
  • Active or prior autoimmune disorders in past 3 years except vitiligo, alopecia, hypothyroidism stable on hormone replacement, psoriasis not requiring systemic treatment, or chronic skin conditions not needing systemic therapy
  • Active hepatitis infection; past/resolved Hepatitis B allowed; Hepatitis C antibody positive allowed only if PCR negative for HCV RNA
  • Positive HIV test or active tuberculosis infection
  • Other invasive cancer within past 5 years
  • Known allergy or hypersensitivity to study drug formulations
  • Active grade 3 or higher edema
  • Uncontrolled illness
  • Current or prior use of immunosuppressive medications within 14 days prior except certain corticosteroids
  • Received live attenuated vaccine within 30 days prior
  • Major surgery within 28 days prior to first dose or still recovering (local surgery allowed without 28-day wait)
  • Pregnant, breastfeeding, or intending to become pregnant during study
  • Any condition that might interfere with safe drug administration or study evaluation as per investigator's judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

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Research Team

M

Malcolm Moore, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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