Using durvalumab and oleclumab before surgery for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the immune response generated by durvalumab and oleclumab in patients with resectable pancreatic ductal adenocarcinoma (PDAC) prior to surgical intervention. It is a multi-site study conducted in Canada, focusing on the potential benefits of these immunotherapies in enhancing the effectiveness of surgery. Participants will receive the treatments before their scheduled surgery, with the aim of assessing immune activity and overall outcomes. The study includes specific eligibility criteria to ensure that participants are suitable for the interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Malcolm Moore, MD — Princess Margaret Cancer Centre/University Health Network
• Study coordinator: Malcolm Moore, MD
• Email: malcolm.moore@uhn.ca
• Phone: 416-946-2263

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant trastuzumab, durvalumab, and FLOT for HER2-positive gastric or GEJ cancer

  This study tests a pre-surgery treatment combining trastuzumab, durvalumab, and FLOT for patients with HER2-positive locally advanced gastric or gastroesophageal junction cancer to see how many achieve complete tumor disappearance.

  Recruiting Phase 2 Samsung Medical Center · Seoul, Gang-Nam · NCT07911280

• Using contrast-enhanced ultrasound to check for local pancreatic cancer recurrence after surgery

  This pilot test uses contrast-enhanced ultrasound to see if it can help detect return of pancreatic cancer after surgery in patients being watched with CT scans.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07910383

• PF-08098488 in adults with advanced solid tumors

  This study tests PF-08098488 in adults whose cancer has progressed or returned after prior treatment.

  Recruiting at 4 sites Phase 1 Pfizer · Grand Rapids, Michigan and 3 other locations · NCT07903415

• Durvalumab with FLOT before and after surgery for resectable gastric/GEJ cancer in Chinese patients

  This trial tests whether adding durvalumab to FLOT chemotherapy before and after surgery helps Chinese patients with resectable gastric or gastroesophageal junction cancer.

  Recruiting at 11 sites Phase 3 AstraZeneca · Beijing and 40 other locations · NCT07877818

• Zolbetuximab added to FLOT and durvalumab before surgery for CLDN18.2-positive gastric/GEJ cancer

  This study tests whether adding zolbetuximab to FLOT chemotherapy plus durvalumab can improve tumor response before surgery in adults with CLDN18.2-positive gastric or GEJ cancer.

  Recruiting Phase 2 National Cancer Center, Japan · Saitama and 3 other locations · NCT07872722

• ABBV-253 in adults with advanced solid tumors

  This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

  Recruiting at 3 sites Phase 1 AbbVie · Grand Rapids, Michigan and 2 other locations · NCT07807956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.