Study on Using Light-Activated Drug and Immunotherapy for Advanced Pancreatic Cancer

Sponsor: Mayo Clinic

Sponsor score: 60

ClinicalTrials ID:NCT06381154

Provider View

This clinical trial is exploring a new treatment approach for pancreatic cancer that cannot be removed by surgery or has spread. The study combines a light-activated drug, verteporfin, with immunotherapy and standard chemotherapy to see if it can better target and kill cancer cells.

Patient Parameters

Program Overview

This study is testing a new treatment for pancreatic cancer that cannot be surgically removed or has spread. The treatment uses a light-activated drug called verteporfin, which becomes active when exposed to light and may help kill cancer cells. It is combined with an immunotherapy drug, pembrolizumab, which helps the immune system attack cancer, and standard chemotherapy drugs. The goal is to see if this combination can more effectively kill cancer cells in patients with advanced pancreatic cancer.

Description

The main goal of this study is to see how well the combination of light-activated verteporfin and pembrolizumab works in treating pancreatic cancer that cannot be removed by surgery. Researchers will measure how many patients respond to the treatment and how long the response lasts. They will also look at how long patients live without the cancer getting worse and overall survival rates. The safety of the treatment will be monitored closely.

Patients will receive verteporfin through an IV and undergo a procedure where light is used to activate the drug in the tumor. They will also receive pembrolizumab through an IV. This treatment cycle repeats every 6 weeks for up to a year, as long as the cancer does not progress and side effects are manageable. Standard chemotherapy drugs will also be given on specific days of the treatment cycle.

After completing the treatment, patients will have follow-up visits to monitor their health and the cancer's status. These visits will occur at 30 and 90 days after treatment, then every 3 months, and eventually every 6 months for up to 3 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of pancreatic cancer that cannot be removed by surgery or has spread.
  • Have measurable disease based on specific medical criteria.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate blood counts and organ function as determined by specific tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
  • Be willing to provide blood and tissue samples for research purposes.
  • Agree to return for follow-up visits and complete questionnaires.

Exclusion Criteria

  • Pregnant or nursing women, or those not willing to use contraception.
  • Have a type of pancreatic cancer other than adenocarcinoma.
  • Have a history of immune system disorders or are taking immune-suppressing medications.
  • Have not recovered from side effects of previous treatments.
  • Have active infections or other serious health conditions that could interfere with the study.
  • Have a history of heart problems or other serious illnesses.
  • Have another active cancer, except for certain non-threatening types.
  • Are taking other investigational drugs for cancer treatment.

Locations

FACILITYZIPCITYSTATE
Mayo Clinic in Rochester55905RochesterMinnesota

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