Actively Recruiting
Photodynamic Priming to Facilitate Immunologic Activity of Anti-PD1 in Patients With Pancreatic Cancer
Led by Mayo Clinic · Updated on 2026-01-30
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a phase II trial to test photoradiation with verteporfin combined with pembrolizumab and standard chemotherapy in patients with pancreatic cancer that cannot be removed by surgery. This includes locally advanced, metastatic, or unresectable pancreatic ductal adenocarcinoma. The study aims to assess how this combination affects tumor response, immune activity, progression, survival, and safety. Participants receive verteporfin intravenously followed by a biopsy and photoradiation guided by endoscopic ultrasound or CT on day 0. Pembrolizumab is administered intravenously on day 1 and repeated every 6 weeks for up to one year if tolerated. Chemotherapy with oxaliplatin, leucovorin, irinotecan, and fluorouracil is given intravenously on specific days in cycles repeating every 42 days for up to six months. Optional lymph node biopsy and imaging studies including CT, PET/CT, and PET/MRI are part of the treatment and assessment. During the study, participants undergo blood sample collections and imaging scans to monitor tumor response and immune changes. They complete quality of life questionnaires and are followed up at 30 and 90 days after treatment, then every 3 months until disease progression, and every 6 months for up to three years. Researchers measure overall response rate, duration of response, progression-free survival, overall survival, and adverse events to evaluate the treatment combination.
CONDITIONS
Brief Title
Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed metastatic, unresectable, or locally advanced pancreatic ductal adenocarcinoma
- Primary tumor in pancreas must still be present
- Up to one prior therapy regimen allowed but no prior FOLFIRINOX treatment
- Measurable disease per iRECIST criteria
- ECOG performance status 0 or 1
- Hemoglobin 9.0 g/dL or higher
- White blood cell count 2500/mm3 or higher
- Absolute neutrophil count 1500/mm3 or higher
- Platelet count 100,000/mm3 or higher
- Total bilirubin less than or equal to 1.5 times upper limit of normal
- ALT and AST less than or equal to 3 times upper limit of normal (or 5 times with liver involvement)
- Acceptable prothrombin time/INR/aPTT or within target range if on anticoagulants
- Creatinine less than or equal to 1.5 times upper limit of normal or creatinine clearance 50 ml/min or higher
- Negative pregnancy test if of childbearing potential
- Ability to provide informed consent
- Ability to complete questionnaires with or without assistance
- Willingness to provide mandatory blood and tissue samples
- Willing to return for follow-up visits during active monitoring phase
You will not qualify if you...
- Pregnant or nursing persons
- Persons unwilling to use adequate contraception if of childbearing potential or able to father a child
- Pancreatic tumor histology other than adenocarcinoma
- More than one prior treatment regimen for pancreatic cancer
- Prior treatment with FOLFIRINOX
- History of immunodeficiency or recent immunosuppressive therapy within 7 days
- Incomplete recovery from prior therapy effects except stable grade 1 peripheral neuropathy
- Severe systemic illnesses or diseases interfering with safety or assessment
- Known HIV infection
- Active hepatitis B or C infection unless controlled and undetectable viral load
- Recent unstable angina, myocardial infarction, or severe heart failure
- Uncontrolled illness including active infection, immune-related lung disease, active autoimmune disease requiring recent systemic treatment
- Need for systemic corticosteroids above certain doses or other immunosuppressive drugs
- Symptomatic congestive heart failure or cardiac arrhythmia
- Psychiatric or social conditions limiting study compliance
- Other active cancers except certain non-invasive or treated types
- Receiving other investigational agents for pancreatic cancer treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive verteporfin intravenously and undergo a biopsy and intratumoral photoradiation using EUS or CT guidance on day 0, followed by pembrolizumab intravenously on day 1. They also receive standard chemotherapy drugs including oxaliplatin, leucovorin, irinotecan, and fluorouracil on specific days during each treatment cycle. Treatment cycles repeat every 6 weeks for up to 1 year or until disease progression or unacceptable toxicity.
Treatment every 6 weeks with multiple drug infusions and procedures; blood samples, CT, PET/CT, and optional PET/MRI assessments throughout
Duration - Up to 3 years after treatment
After completing treatment, participants are followed up at 30 and 90 days, then every 3 months until disease progression, and every 6 months for up to 3 years to monitor health and survival.
Visits at 30 and 90 days post-treatment, then every 3 months and later every 6 months
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
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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