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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06381154
Phase
PHASE2
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT or PET/CT
  • Endoscopic Ultrasound — PROCEDURE
    Undergo EUS
  • Fluorouracil — DRUG
    Given IV
  • Irinotecan — DRUG
    Given IV
  • Leucovorin — DRUG
    Given IV
  • Lymph Node Biopsy — PROCEDURE
    Undergo lymph node biopsy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo PET/MRI
  • Oxaliplatin — DRUG
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Photodynamic Therapy — DRUG
    Undergo intratumoral photoradiation
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT and PET/MRI
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Verteporfin — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Dec 6, 2024
Status verified
Jan 2026
Primary completion
Dec 6, 2029
Completion
Dec 6, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (verteportin, photoradiation, pembrolizumab)
    Patients receive verteporfin IV and undergo a biopsy and intratumoral photoradiation over 60-90 minutes using EUS or CT guidance on day 0. Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also receive standard of care oxaliplatin IV over 2-6 hours, leucovorin IV over 15 minutes - 2 hours, irinotecan IV over 90 minutes, and fluorouracil IV on days 3, 15 and 29 of cycle 1 only, then on days 1, 15, and 29 of remaining cycles. Cycles repeat every 42 days for up to 6 months in the absence of disease progression or unacceptable toxicity. Patients may optionally undergo lymph node biopsy on day 2 or 3 of cycle 1. Additionally, patients undergo blood sample collection, CT, PET/CT and optional PET/MRI on study.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Vinay Chandrasekhara, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By research site
Mayo Clinic in Rochester· Rochester, MN

Related Studies