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IRE/Pembrolizumab for Pancreatic Cancer

Phase 1

Recruiting

Led By Mokenge Malafa, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be age 18-74 years at diagnosis.

Performance-status Eastern Cooperative Oncology Group (ECOG) of 0-1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study Summary

This trial will test if combining two treatments, Irreversible Electroporation (IRE) and Immunotherapy (IO), is safe and tolerable for patients with advanced pancreatic cancer. The patients in the

Who is the study for?

This trial is for patients with locally advanced pancreatic cancer that can't be removed by surgery. They should have already undergone initial chemotherapy and a type of precise radiation therapy called A-SMART.Check my eligibility

What is being tested?

The study tests the safety of using Irreversible Electroporation (IRE), a technique to destroy cancer cells, followed by Pembrolizumab, an immunotherapy drug, in treating pancreatic cancer.See study design

What are the potential side effects?

Possible side effects include skin reactions at the IRE site, flu-like symptoms, fatigue, and immune-related issues such as inflammation in organs due to Pembrolizumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with my condition between the ages of 18 and 74.

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I am fully active or can carry out light work.

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My pancreatic cancer is confirmed and is at stage 3.

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I have pancreatic cancer, followed the first-line treatment without disease progression.

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My organs and bone marrow are working well.

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I am willing to switch my blood thinner to enoxaparin if needed.

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My tumor is 3.5 cm or smaller after initial treatment.

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My tumor cannot be removed with surgery according to NCCN guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months 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

Objective Response Rate (ORR)

Overall Survival (OS)

Progression-Free Survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: IRE/PembrolizumabExperimental Treatment2 Interventions

Participants will undergo irreversible electroporation (IRE) using the NanoKnife system. About 1 week following IRE, study participants will receive a 200mg dose of pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Irreversible Electroporation

2017

Completed Phase 2

~50

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Angiodynamics, Inc.Industry Sponsor

23 Previous Clinical Trials

2,362 Total Patients Enrolled

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,479 Total Patients Enrolled

Mokenge Malafa, MDPrincipal InvestigatorMoffitt Cancer Center

Frequently Asked Questions

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

What is the overall patient enrollment count for this clinical trial?

"Indeed, information from clinicaltrials.gov shows that this research project is actively pursuing suitable participants. The trial was initially listed on April 10th, 2024 and had its latest update on April 17th, 2024. They are currently seeking to enroll three patients across one site."

Answered by AI

Is the enrollment phase of this medical study currently ongoing?

"Affirmative. Information from clinicaltrials.gov confirms the ongoing recruitment of participants for this investigation. Initially shared on April 10, 2024, and most recently revised on April 17, 2024, the study aims to enroll a total of three subjects at one designated site."

Answered by AI

Has the combination of IRE and Pembrolizumab been officially sanctioned by the FDA?

"Given that this is a Phase 1 trial with minimal safety and efficacy data, our team at Power rates the safety of IRE/Pembrolizumab as a level 1 on our scale."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Irreversible Electroporation & Pembro Immunotherapy in Locally Advanced Pancreatic Cancer

2024. "Irreversible Electroporation & Pembro Immunotherapy in Locally Advanced Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06378047.

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