Study Details

Open

Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer

This study is being done to answer the following question: What is the dose of durvalumab and olaparib in combination with radiation therapy that can be safely and tolerably taken by patients with pancreatic cancer? It is been done because we want to find out if this approach is better or worse than the usual approach for your pancreatic cancer. The usual approach is defined as care most people get for pancreatic cancer

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

During screening patients will be consented, have a physical exam, vitals collected, labs collected (both SOC and study), an EKG, imaging scan, and tissue collection. During study treatment patients will have physical exams, vitals collected, labs collected (both SOC and study), EKG(s), imaging scans, AEs monitored, tissue collected, and study drug treatment.

Total length of participation:
Up to 4 years

Looking for Specific Volunteers

Able to participate:

Patient has confirmed pancreatic cancer that is locally advanced and unresectable.
Patient has had prior first-line chemotherapy for this cancer for at least 16 weeks without progression.
Patient has adequate organ and marrow function per the study's lab criteria.
Patient is willing to provide archival tissue from a previous biopsy.
Patient has measurable or evaluable disease per CT or MRI scan.

Not eligible if:

Patient has had prior upper abdominal radiotherapy.
Patient had a major surgical procedure within 28 days prior to study enrollment.
Patient has not recovered from Grade 2 or greater adverse events from prior cancer therapy (some exceptions apply).
Patient has a history of allergic reactions related to compounds of similar chemical or biologic composition to olaparib or durvalumab.
Patient has a germline BRCA1 or BRCA2 mutation.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Ashwin Somasundaram
Medicine- Oncology

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Pancreatic)

IRB Number

22-3286

ClinicalTrials.gov

NCT05411094