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IRE + CD40 Antibody for Pancreatic Cancer

Phase 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and tolerability

Secondary outcome measures

Overall survival

Progression-free survival

Systemic immune effects

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,675 Previous Clinical Trials

40,926,959 Total Patients Enrolled

University of California, Los AngelesOTHER

1,533 Previous Clinical Trials

10,265,550 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,123 Previous Clinical Trials

1,552,821 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to participate in this ongoing medical study?

"As per the information provided by clinicaltrials.gov, this study is not currently seeking participants. The trial was initially posted on February 1st, 2024 and last updated on January 4th, 2024. However, it's worth noting that there are currently a total of 710 ongoing trials actively recruiting patients at present."

Answered by AI

Has the combination of IRE and CD40 Antibody been given official approval by the FDA?

"This particular trial, being a Phase 1 study, has limited safety and efficacy data available for IRE + CD40 Antibody. As a result, our team at Power rates its safety as 1 on a scale from 1 to 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer

Rebekah White 2024. "Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06205849.

All > Pancreas Cancer > Immunotherapy