NCT04543071 · Gulam Manji
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
What this study is about
The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe.
View original scientific description
The purpose of this study is to determine if combination treatment with cemiplimab, motixafortide, gemcitabine, and nab-paclitaxel is effective in decreasing the size of the tumor(s), if it will prolong life in patients, and if it's safe. The treatment consists of standard chemotherapy (gemcitabine and nab-paclitaxel) which is FDA approved and is standard treatment for patients with pancreatic adenocarcinoma.
Interventions
DRUG
Motixafortide
1.25 mg/kg subcutaneous (SC) monotherapy daily for 5 days during priming, followed by twice weekly
DRUG
Cemiplimab
350 mg intravenous (IV) once every 21 days
DRUG
Gemcitabine
1000 mg/m2 IV on days days 1, 8, 14 (every 28 days)
DRUG
Nab paclitaxel
125 mg/m2 IV on days 1, 8, 14 (every 28 days)
Primary outcome measures
Overall Response Rate (Complete Response (CR) + Partial Response (PR))
Time frame: 16 weeks
Complete response is defined as the disappearance of all lesions. Partial response is defined as ≥30% decrease in the sum of diameters of target lesions, in the absence of CR, new lesions, and unequivocal progression in non-target lesions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Histological or pathological confirmation of metastatic pancreas adenocarcinoma 1. Cytologic or histologic proof of pancreas adenocarcinoma needs to be verified by the treating institution pathologist, either from the initial diagnostic biopsy or from the required pre-treatment biopsy, prior to initiation of any study-related therapy. 2. Pathologic confirmation of metastatic (stage IV) disease (unresectable) on research pretreatment biopsy is required prior to initiation of therapy. 3. Patients with endocrine or acinar pancreatic carcinoma are not eligible for the study. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Age ≥18 years 4. Adequate hematological and end-organ function (test results from within 14 days prior to initiation of study treatment): 1. Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without granulocyte colony-stimulating factor support 2. White Blood Cell Count (WBC) count ≥ 2.5 x 109 /L (2500/uL)
Where
- New York, New York
- Providence, Rhode Island
- Milwaukee, Wisconsin
Collaborators
Regeneron Pharmaceuticals, BioLine Rx
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 19, 2025 · Source of record for eligibility and locations