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Mitazalimab + IRE for Pancreatic Cancer

Phase 1
Recruiting
Led By Rebekah R White, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically/cytologically-confirmed pancreatic ductal adenocarcinoma (PDAC)
Locally advanced disease that is not amenable to surgical resection as defined by the Alliance for Clinical Trials in Oncology
Must not have
Known allergic reactions to components of the mitazalimab solution (L-Histidine, trehalose, or polysorbate 20)
Fever > 38 degrees C within 14 days of study intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for locally advanced pancreatic cancer. The treatment involves injecting a medication called mitazalimab directly into the tumor during surgery. This method of delivery may be more effective

Who is the study for?
This trial is for individuals with locally advanced pancreatic cancer who are eligible for a procedure called IRE. The study aims to test the safety and effectiveness of injecting a drug directly into the tumor during this procedure.
What is being tested?
The trial is testing mitazalimab, an immune-stimulating antibody, given by direct injection into the tumor at the time of IRE surgery. It's compared with just having IRE (also known as NanoKnife), which uses electrical currents to destroy cancer cells.
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapy such as flu-like symptoms, fatigue, fever, and possible local reactions at the injection site. Since it's injected directly into the tumor, systemic side effects might be reduced.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed as pancreatic ductal adenocarcinoma.
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My cancer cannot be removed with surgery.
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I have completed at least 4 months of FOLFIRINOX chemotherapy.
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I can take care of myself and perform daily activities.
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My tumor can be completely removed and is smaller than 4.0 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not allergic to L-Histidine, trehalose, or polysorbate 20.
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I have not had a fever over 38°C in the last 14 days.
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I have had radiation therapy targeting my pancreas.
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I have heart rhythm problems that can't be controlled.
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My cancer has spread to distant parts of my body.
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I cannot undergo major surgery with general anesthesia due to a health condition.
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I have been treated with a CD40 antibody before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability
Secondary study objectives
Overall survival
Progression-free survival
Systemic immune effects

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: IRE + CD40 AntibodyExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NanoKnife
2013
N/A
~460

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,018,118 Total Patients Enrolled
University of California, Los AngelesOTHER
1,566 Previous Clinical Trials
10,263,436 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,575,029 Total Patients Enrolled
~12 spots leftby Aug 2027
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