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

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.

Conditions

• Locally Advanced Pancreatic Adenocarcinoma
• Metastatic Pancreatic Adenocarcinoma
• Stage II Pancreatic Cancer AJCC v8
• Stage III Pancreatic Cancer AJCC v8
• Stage IV Pancreatic Cancer AJCC v8
• Unresectable Pancreatic Adenocarcinoma

Interventions

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

PROCEDURE

Endoscopic Ultrasound

Undergo EUS

DRUG

Fluorouracil

Given IV

DRUG

Irinotecan

Given IV

DRUG

Leucovorin

Given IV

PROCEDURE

Lymph Node Biopsy

Undergo lymph node biopsy

PROCEDURE

Magnetic Resonance Imaging

Undergo PET/MRI

DRUG

Oxaliplatin

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Photodynamic Therapy

Undergo intratumoral photoradiation

PROCEDURE

Positron Emission Tomography

Undergo PET/CT and PET/MRI

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Verteporfin

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Vinay Chandrasekhara, MD · Mayo Clinic in Rochester

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-12-06

Primary Completion

2029-12-06

Completion

2029-12-06

FDA Drug

Yes

Countries

• United States

Study Locations