Imaging and predicting response to CCR2-targeted therapy in pancreatic cancer
Novel CCR2 PET for Pancreatic Cancer Imaging and Prediction of Response to Standard and CCR2-Targeted Therapy
This study is testing a new imaging method to see if it can help doctors find out which patients with pancreatic cancer might benefit from a specific treatment.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | nivolumab, chemotherapy, immunotherapy |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT03851237 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a novel CCR2 imaging agent in patients with pancreatic ductal adenocarcinoma (PDAC) to identify those who may benefit from CCR2-targeted therapy. The study will involve adult patients with newly diagnosed or advanced PDAC, utilizing PET/CT imaging to assess the presence of CCR2 and predict treatment responses. By selecting appropriate candidates for therapy, the trial seeks to minimize unnecessary toxicity and costs associated with ineffective treatments. The findings could significantly advance the fields of cancer immunotherapy and tumor biology.
Who should consider this trial
Good fit: Ideal candidates include adults with newly diagnosed or advanced pancreatic ductal adenocarcinoma who are scheduled for surgery or chemotherapy.
Not a fit: Patients with non-resectable pancreatic cancer who are not candidates for CCR2-targeted therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with pancreatic cancer.
How similar studies have performed: Other studies have shown promise in using imaging agents for targeted therapies, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients 18 years of age or older with: * newly diagnosed early-staged localized pancreatic ductal adenocarcinoma (PDAC) scheduled to undergo Whipple procedure (cohort 1a) or down-staged after neoadjuvant chemotherapy now eligible to undergo resection OR * borderline resectable, locally advanced, metastatic, or recurrent PDAC (cohort 1b) scheduled to undergo chemotherapy OR * borderline resectable, locally advanced PDAC (cohort 2) who is eligible and / or signed consent to undergo CCR2-targeted therapy example:\[(phase 1/2 clinical trial combining an oral CCR2/5i (BMS-813160) with chemotherapy (gemcitabine plus nab-paclitaxel) and anti-PD-1 (nivolumab), PI, Dr. Kian Lim) HRPO #201806007 - closed to accrual March 2022\] AND * at least one measurable \[defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan or MRI\] A cohort 1B subject who has been previously treated for PDAC with a diagnosis of recurrence and a lesion size of 1.5 cm or greater will be allowed to enroll before institution of therapy or within 20 days after starting a 2nd line or later (new therapy) for recurrent disease. * Able to give informed consent * Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-DOTA-ECL1i) is negative Exclusion Criteria: * Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years * Unable to tolerate up to 90 min of PET/CT imaging per imaging session.
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Farrokh Dehdashti, M.D. — Washington University School of Medicine
- Study coordinator: Farrokh Dehdashti, M.D.
- Email: dehdashtif@wustl.edu
- Phone: 314-362-1474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.