Study Details

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AIRPanc - Ph2 Randomized Study Evaluating Patients with advanced Pancreatic Ductal Adenocarcinoma

The purpose of this study is to combine standard radiation therapy with drugs that stimulate the body's immune system against cancer cells (by targeting the protein PD-1), while adding drugs which also target the pathway that the tumor uses to evade the immune system (the CD73 and A2a/b pathways).The main goal of this study is to find out if study treatment with zimberelimab (an antibody which binds the protein PD-1) and stereotactic body radiation therapy (SBRT) alone or in combination with quemliclustat (a drug which blocks CD73), with or without etrumadenant (a drug which blocks the A2a/b) given before surgery is safe and if it can further increase the immune response against the tumor.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Extended hours (M-F, early morning or evening)
Visits can be combined with regular clinical appointments

Location

United States (Nationwide)

What will be asked of you

All subjects included in stage 1 of the study will receive SBRT and all study drugs (zimberelimab, quemlicustat, and etrumadenant). During stage 2, participants will receive one of three different study treatment combinations and you will have a 1 in 3 chance of receiving any of the study treatment combinations. If you are part of the second stage of the study, a computer will by chance assign you to study treatment groups in the study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the others. Most of the exams, tests, and procedures you will have are part of the standard of care for your condition, however, there are some extra exams for research purposes, blood tests, and CT and or MRI scans that you will need to have if you take part in this study. During your participation in the study, you will come into the clinic for at least five study specific visits which we will combine with your standard clinical visits as much as possible. Before you begin the study: During Screening, you will review and sign this informed consent and we will confirm that you can take part in this study. We will review your demographic information, medical and prior anticancer treatment history. Additionally, you will need to have extra exams, tests, and procedures in order to see if you are eligible to participate:

In-person visits:
12

Total length of participation:
36 months

Looking for Specific Volunteers

Able to participate:

Histological or pathological confirmation of pancreatic adenocarcinoma
Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
On stable full dose anticoagulation for 8 weeks.
Eligible to undergo SBRT.

Not eligible if:

Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable).
Patients who are receiving any other investigational agents concurrently.
Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

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

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
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

24-0729

ClinicalTrials.gov

NCT06048484