Pancreatic Cancer study: NanoKnife
Official title Intra-tumoral Mitazalimab (CD40 Antibody) With Irreversible Electroporation (IRE) in Locally Advanced Pancreas Cancer
ClinicalTrials.gov ID: NCT06205849
What this study is testing
What is IRE + intratumoral mitazalimab (CD40 antibody) injection?
An investigational combination of irreversible electroporation and a CD40 antibody being studied as a potential treatment for locally advanced pancreatic cancer. It is designed to use electric pulses to destroy tumor cells (IRE) and a CD40 agonist antibody to activate immune cells against the cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if injecting the CD40 antibody mitazalimab straight into the tumor during irreversible electroporation (IRE) is safe and can boost the immune response to lower the chance of cancer coming back.
- Who it's for
- Adults who have locally advanced pancreatic cancer and are scheduled for IRE surgery.
- What's involved
- Participants will receive a single injection of mitazalimab into the tumor at the time of the IRE procedure, followed by routine monitoring and tests to check safety and immune effects.
- Time commitment
- The trial involves the surgery day plus several follow‑up visits over a few months to monitor recovery and outcomes.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Histologically/cytologically-confirmed pancreatic ductal adenocarcinoma (PDAC)
- Persons, aged \> 18 years of age, as PDAC is extremely rare in pediatric populations.
- Occlusion of the superior mesenteric vein (SMV) and/or portal vein (PV) that is not amenable to resection and venous reconstruction
You likely can't join if
- Pregnancy or lactation
- 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
- Treatment with another investigational drug or other intervention within 30 days of enrollment
- Prior treatment with a CD40 antibody
- History of severe auto-immune disease
See the full eligibility criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Histologically/cytologically-confirmed pancreatic ductal adenocarcinoma (PDAC)
- Persons, aged \> 18 years of age, as PDAC is extremely rare in pediatric populations.
- Occlusion of the superior mesenteric vein (SMV) and/or portal vein (PV) that is not amenable to resection and venous reconstruction
- Interface between tumor and hepatic artery that is not amenable to resection and reconstruction
- Interface between the tumor and superior mesenteric artery (SMA) measuring \> 180º of the circumference of the vessel wall
- Interface between the tumor and celiac axis measuring \> 180º of the circumference of the vessel wall that is not amenable to resection
- ECOG Performance Status of 0-2
- Absolute neutrophil count (ANC) ≥ 1.5x109/L
- Platelets ≥ 100x109/L
- Hemoglobin ≥9 g/dL
- Serum creatinine ≤1.5 x ULN OR creatinine clearance ≥40 mL/min (as calculated by Modified Cockcroft-Gault formula)
- Serum total bilirubin ≤ 1.5 X ULN
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN
- A minimum of 4 months of one of the chemotherapy regimens preferred by the NCCN for good performance status patients (currently modified FOLFIRINOX, gemcitabine + albumin-bound paclitaxel, or NALIRIFOX)
- High quality imaging triphasic CT scan contrast-enhanced dynamic MRI of abdomen and either contrast-enhanced or non-contrast CT of chest and pelvis that demonstrate no evidence of metastatic disease within 30 days of...
- FDG-PET imaging (skullbase-midthigh) at any timepoint between diagnosis and study intervention to determine whether tumor is PET-avid and evaluate for extra-pancreatic metastatic disease, as suggested by NCCN guidelines...
- Tumor amenable to "in situ" (complete) ablation with maximum primary tumor dimension \< 4.0 cm
- For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method until the study intervention and for an additional 1 month after...
- For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner for 1 month after study intervention.
- Pregnancy or lactation
- 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
- Treatment with another investigational drug or other intervention within 30 days of enrollment
- Prior treatment with a CD40 antibody
- History of severe auto-immune disease
- The presence of metal fiducials or embolization coils within the tumor.
- Prior receipt of radiation therapy to the pancreas
- The presence of implanted metallic cardiac stimulation devices within the chest
- Uncontrolled cardiac arrhythmias that prevent synchronization of pulse delivery with the refractory period of the cardiac cycle
- Immunosuppressive doses of systemic medications, such as corticosteroids or absorbed topical corticosteroids (doses \> 10 mg/day prednisone or equivalent) must be discontinued at least 2 weeks (14 days) before study...
- Any medical condition that precludes major abdominal surgery under general anesthesia
- Presence of distant metastatic disease (including positive peritoneal cytology) on staging laparoscopy and/or exploratory laparotomy at any timepoint.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.