Is NCT06205849 recruiting in La Jolla, CA?

Yes, NCT06205849 is currently recruiting participants at its La Jolla, CA location. This pancreatic cancer clinical trial is actively enrolling qualified participants.

How do I join the pancreatic cancer clinical trial in La Jolla?

To join this clinical trial in La Jolla, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this La Jolla clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Pancreatic Cancer Clinical Trial in La Jolla, CA

About This Pancreatic Cancer Study in La Jolla

This is a phase I study of an agonistic CD40 antibody (mitazalimab) injected intratumorally at the time of surgical IRE in patients with locally advanced pancreatic cancer. Intratumoral delivery has potential to be more effective than systemic (intravenous) delivery while decreasing the systemic side effects of immunotherapy. We hypothesize that local delivery of mitazalimab at the time of IRE in patients with locally advanced pancreatic cancer will be safe, augment the immune effects of IRE, and decrease the risk of recurrence.

Sponsor: University of California, San Diego

Who Can Participate

Inclusion 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.

Locally advanced disease that is not amenable to surgical resection. Locally advanced PDAC cases will be identified per the definition developed by the Alliance for Clinical Trials in Oncology\[53\]. Per this definition, locally advanced PDAC is defined as presence of any one or more of the following on CT:

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

Have adequate organ function per criteria below:

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 enrollment

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 for high-risk patients.

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 the study intervention.

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.

Exclusion Criteria

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 treatment administration. Physiologic doses of corticosteroids (≤ 10 mg/day of prednisone or its equivalent) or short pulses of corticosteroids (≤ 3 days) may be permitted.

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in La Jolla?

Yes, this clinical trial (NCT06205849) has an active research site in La Jolla, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Pancreatic Cancer Treatment Options in La Jolla, CA

If you're searching for pancreatic cancer treatment options in La Jolla, CA, this clinical trial (NCT06205849) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our La Jolla research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced pancreatic cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all pancreatic cancer clinical trials near you to find additional studies recruiting in your area.

Pancreatic Cancer Clinical Trial in La Jolla, CA

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