Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06381154

Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

Led by Mayo Clinic · Updated on 2026-01-30

25

Participants Needed

1

Research Sites

260 weeks

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

This phase II trial tests how well photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy works in treating patients with pancreatic cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Photoradiation uses light activated drugs, such as verteporfin, that become active when exposed to light. These activated drugs may kill tumor cells. Vertoporfin may also increase tumor response to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy may kill more tumor cells in patients with unresectable, locally advanced or metastatic pancreatic cancer.

CONDITIONS

Official Title

Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Confirmed diagnosis of metastatic, unresectable, or locally advanced pancreatic ductal adenocarcinoma
  • Primary tumor in the pancreas must still be present
  • Up to one prior therapy regimen allowed, but no prior FOLFIRINOX treatment
  • Measurable disease by immune-related criteria
  • ECOG performance status of 0 or 1
  • Hemoglobin at least 9.0 g/dL within 15 days before registration
  • White blood cell count at least 2500/mm3 within 15 days before registration
  • Absolute neutrophil count at least 1500/mm3 within 15 days before registration
  • Platelet count at least 100,000/mm3 within 15 days before registration
  • Total bilirubin no more than 1.5 times the upper limit of normal within 15 days before registration
  • ALT and AST no more than 3 times upper limit of normal (or 5 times if liver involved) within 15 days before registration
  • Normal coagulation tests or within target range if on anticoagulants within 15 days before registration
  • Creatinine no more than 1.5 times upper limit of normal or creatinine clearance at least 50 ml/min within 15 days before registration
  • Negative pregnancy test within 8 days before registration for persons who can become pregnant
  • Able to give informed consent
  • Able to complete questionnaires alone or with help
  • Willing to provide required blood and tissue samples for research
  • Willing to return for follow-up visits during active monitoring
Not Eligible

You will not qualify if you...

  • Pregnant or nursing persons, or those unwilling to use adequate contraception if able to conceive or father a child
  • Pancreatic tumor histology other than adenocarcinoma
  • More than one prior treatment regimen for pancreatic cancer
  • Prior treatment with FOLFIRINOX chemotherapy
  • History of immune deficiency or recent immunosuppressive therapy within 7 days before registration
  • Not recovered from acute effects of prior treatment except stable mild neuropathy
  • Severe systemic illnesses or other diseases that could interfere with safety or assessment
  • Known HIV infection
  • Active hepatitis B or C infection unless on treatment and viral load undetectable
  • Recent serious heart conditions or unstable heart disease
  • Uncontrolled infections or immune-related lung diseases requiring steroids
  • Active autoimmune disease requiring systemic treatment within 2 years
  • Use of systemic corticosteroids over 10 mg prednisone equivalent daily or other immunosuppressants unless for allowed conditions
  • Symptomatic congestive heart failure or unstable angina
  • Cardiac arrhythmia or psychiatric/social conditions limiting study compliance
  • Other active cancers except certain treated in situ or non-melanotic skin cancers
  • Receiving other investigational agents for pancreatic cancer treatment

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

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

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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