Trial Title:
Irreversible Electroporation & Pembro Immunotherapy in Locally Advanced Pancreatic Cancer
NCT ID:
NCT06378047
Condition:
Pancreatic Cancer
Locally Advanced Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Pembrolizumab
Conditions: Keywords:
Pancreatic Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab is an immunotherapy that will be administered via IV infusion.
Arm group label:
IRE/Pembrolizumab
Other name:
Keytruda
Intervention type:
Device
Intervention name:
Irreversible Electroporation
Description:
Participants will undergo IRE as standard of care treatment.
Arm group label:
IRE/Pembrolizumab
Other name:
NanoKnife
Summary:
This study aims to determine the safety and tolerability of combining sequential therapy
of Irreversible Electroporation (IRE) and Immunotherapy (IO) for patients with locally
advanced unresectable pancreas cancer following first-line treatment with chemotherapy
and ablative stereotactic magnetic resonance image-guided adaptive radiation therapy
(A-SMART).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participant must consent to enrollment in the Moffitt Cancer Center (MCC) Total
Cancer Care (TCC) Protocol for tissue and blood banking and must have their initial
biopsy tissue available.
- Participant must be willing and able to comply with scheduled visits, treatment
plans, laboratory tests, biopsies when required, and other procedures.
- Histologically or cytologically confirmed PDAC meeting the AJCC 8th edition staging
criteria of stage 3 disease.
- Tumor(s) is/are locally advanced and unresectable pursuant to NCCN guidelines.
- Participant must be age 18-74 years at diagnosis.
- Performance-status Eastern Cooperative Oncology Group (ECOG) of 0-1.
- Radiologically measurable disease per iRECIST version 1.1.
- Prior to TCC registration, participants must have no prior therapy for PDAC and fall
under treatment NCCN pancreatic adenocarcinoma guides (v1.2022) for locally advanced
disease. Before study consent, the participant must have had standard of care
first-line therapy consisting of 12 weeks of FOLFIRINOX (at least 6 cycles),
followed by 50 Gy of A-SMART, delivered in five 10-Gy fractions. Participant must
show no evidence of disease progression after first-line treatment, based upon
National Comprehensive Cancer Network (NCCN) guidelines.
- The maximum axial tumor dimension must be ≤3.5 cm after "first strike" standard of
care treatment.
- Participants must have adequate organ and marrow function.
- Resolved acute effects of any prior therapy and/or grade ≤1 late toxicity according
to CTCAE version 5.0.
- If a participant requires anticoagulation, treatment must be modified to enoxaparin.
- Negative serum pregnancy test if female participant is of child-bearing potential.
At screening, all female participants of child-bearing age will undergo a urine
pregnancy test. If urine test is positive or inconclusive, a serum test will be
performed.
- Women of child-bearing potential (WOCBP) and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation. In addition, WOCBP must
agree to continue using adequate contraception for 4 months after pembrolizumab
administration. If a woman is breastfeeding, she should stop study drug.
- Patients must be eligible for standard of care (SoC) NanoKnife therapy.
Exclusion Criteria:
- Clinical evidence of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE), prior
history of Cerebral Vascular Accident (CVA), or history of Transient Ischemic Attack
(TIA) within 12 months or other known TE event present during the screening period.
- Clinically significant (i.e., active) cardiovascular disease: myocardial infarction
(<6 months prior to enrollment), unstable angina, congestive heart failure (≥ New
York Heart Association Classification Class II), serious cardiac arrhythmia
requiring medication.
- Participants who have implanted cardiac pacemakers, defibrillators, or implanted
devices with bare metal parts in the thoracic cavity, abdomen, and/or
retroperitoneum.
- Currently receiving treatment with medication that has a known risk to prolong the
QT interval or to induce Torsades de Pointes, and the treatment cannot be
discontinued or switched to a different medication prior to starting study
treatment.
- Participant has other concurrent severe and/or uncontrolled medical conditions that
would, in the Investigator's judgment, contraindicate patient participation in the
clinical study.
- Contraindication to heparin as per institutional guidelines.
- Another primary cancer within the last 3 years requiring systemic therapy.
- Participant has had major surgery within 14 days prior to starting study treatment
or has not recovered from major side effects.
- Participant is currently receiving increasing or chronic treatment (>5 days) with
corticosteroids or another immunosuppressive agent within 2 weeks of study
participation or has an active autoimmune disease that might deteriorate when
receiving an immunostimulatory agent.
- Participant is being treated at start of study treatment with any of the following
drugs: a. Drugs known to be strong or moderate inhibitors or inducers of isoenzyme
cytochrome P450 3A4 (CYP3A4), including herbal medications. b. Drugs with a known
risk of inducing Torsades de Pointes. Note: The patient must have discontinued
strong inducers for at least 1 week and must have discontinued strong inhibitors
before the treatment is initiated. Switching to a different medication prior to
starting study treatment is allowed.
- Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis
C.
- Known prior severe hypersensitivity to investigational product, hyaluronidase, or
any component in its formulations, including known severe hypersensitivity reactions
to monoclonal antibodies (NCI CTCAE version 5 grade ≥ 3).
- Participant has a medically documented poorly controlled psychiatric disorder(s),
alcohol abuse, or drug abuse as defined according to the Diagnostic and Statistical
Manual of Mental Disorders Fifth Edition (DSM-V).
- Gastrointestinal arteriovenous malformations.
- Local gastrointestinal organ (e.g., stomach, duodenum) invasion by tumor.
- Participant is unable to undergo magnetic resonance imaging (MRI) due to
incompatible implanted device, body habitus, and/or phobia unamenable to anxiolytic
therapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Alicia Chin
Phone:
813-745-4673
Email:
Alicia.Chin@moffitt.org
Contact backup:
Last name:
Victoria Kryliouk
Email:
Victoria.Kryliouk@moffitt.org
Investigator:
Last name:
Mokenge Malafa, MD
Email:
Principal Investigator
Investigator:
Last name:
Mohammed Al-Jumayli, MD
Email:
Sub-Investigator
Investigator:
Last name:
Junsung Choi, MD
Email:
Sub-Investigator
Investigator:
Last name:
James Costello, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Aamir Dam, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jason Denbo, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sophie Dessureault, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Martine Extermann, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Jessica Frakes, MD
Email:
Sub-Investigator
Investigator:
Last name:
Pamela Hodul, MD
Email:
Sub-Investigator
Investigator:
Last name:
Sarah Hoffe, MD
Email:
Sub-Investigator
Investigator:
Last name:
Dae Won Kim, MD
Email:
Sub-Investigator
Investigator:
Last name:
Richard Kim, MD
Email:
Sub-Investigator
Investigator:
Last name:
Bela Kis, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Allan Lima Pereira, MD, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Shaffer Mok, MD
Email:
Sub-Investigator
Investigator:
Last name:
Russell Palm, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jose Pimiento, MD
Email:
Sub-Investigator
Investigator:
Last name:
Paulo Rodriguez, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Christine Sam, MD
Email:
Sub-Investigator
Investigator:
Last name:
Andrew Sinnamon, MD
Email:
Sub-Investigator
Investigator:
Last name:
Amalia Stefanou, MD
Email:
Sub-Investigator
Investigator:
Last name:
Jonathan Strosberg, MD
Email:
Sub-Investigator
Investigator:
Last name:
John Bryant, MD
Email:
Sub-Investigator
Start date:
April 10, 2024
Completion date:
April 2027
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Collaborator:
Agency:
Angiodynamics, Inc.
Agency class:
Industry
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06378047
