RecruitingPhase 2NCT06381154

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

Photodynamic Priming to Facilitate Immunologic Activity of Anti-PD1 in Patients With Pancreatic Cancer


Sponsor

Mayo Clinic

Enrollment

25 participants

Start Date

Dec 6, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a light-activated drug (verteporfin, used as a form of photodynamic therapy) given alongside pembrolizumab (an immunotherapy) can help the immune system better attack pancreatic cancer. The light treatment is delivered directly to the tumor during an endoscopy procedure. **You may be eligible if...** - You are 18 or older - You have confirmed pancreatic cancer (ductal adenocarcinoma) that cannot be surgically removed - The primary tumor in the pancreas is still present - You have received at most one prior treatment regimen (but not FOLFIRINOX) - Your cancer can be measured on scans - You are in reasonably good health (ECOG 0-2) **You may NOT be eligible if...** - You have previously received FOLFIRINOX chemotherapy - You have had more than one prior treatment for this cancer - Your overall health is too poor for the treatments - You have conditions that prevent safe use of the drugs or procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT or PET/CT

PROCEDUREEndoscopic Ultrasound

Undergo EUS

DRUGFluorouracil

Given IV

DRUGIrinotecan

Given IV

DRUGLeucovorin

Given IV

PROCEDURELymph Node Biopsy

Undergo lymph node biopsy

PROCEDUREMagnetic Resonance Imaging

Undergo PET/MRI

DRUGOxaliplatin

Given IV

BIOLOGICALPembrolizumab

Given IV

DRUGPhotodynamic Therapy

Undergo intratumoral photoradiation

PROCEDUREPositron Emission Tomography

Undergo PET/CT and PET/MRI

OTHERQuestionnaire Administration

Ancillary studies

DRUGVerteporfin

Given IV


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06381154


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