Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGulam Manji
About this trial
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. Participants will receive immunotherapy (cemiplimab) which activates the body's immune system to attack cancer cells. Cemiplimab is FDA approved for treatment of skin cancer but not for pancreas cancer. Participants will also receive Motixafortide, a new medication which has shown in the laboratory to help immunotherapy work better. Motixafortide has been tested together with immunotherapy (Pembrolizumab), and chemotherapy (5-Fluorouracil and liposomal Irinotecan) and was deemed safe to test additional patients. Motixafortide has not been tested with the specific immunotherapy (Cemiplimab) and chemotherapy (gemcitabine and nab-paclitaxel) which participants will receive and is being tested in this clinical trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histological or pathological confirmation of metastatic pancreas adenocarcinoma
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.
Pathologic confirmation of metastatic (stage IV) disease (unresectable) on research pretreatment biopsy is required prior to initiation of therapy.
Patients with endocrine or acinar pancreatic carcinoma are not eligible for the study.
Disqualifiers
Prior systemic therapy for PDAC: Participants may not have had systemic chemotherapy, investigational therapy, or treatment with T-cell co-stimulating or immune check point blockade therapies (including anti-CTLA-4, anti PD-1, and anti PD-L1 therapeutic antibodies) prior to initiation of study treatment.
Prior radiation therapy for PDAC Participants may not have had radiation therapy to within two weeks prior to initiation of study treatment. Participants may not have had previous radiotherapy to the primary pancreas lesion or a metastatic site except for palliation for pain. Participants who receive radiation to 25% or more of the bone marrow will be excluded.
Prior surgery for PDAC Participants may not have had surgical resection of PDAC prior to initiation of study treatment
Patients currently receiving any other investigational agents
Trial design
Design model
Single group
Treatments tested in this trial
Motixafortide
Drug1.25 mg/kg subcutaneous (SC) monotherapy daily for 5 days during priming, followed by twice weekly
Cemiplimab
Drug350 mg intravenous (IV) once every 21 days
Gemcitabine
Drug1000 mg/m2 IV on days days 1, 8, 14 (every 28 days)
Nab paclitaxel
Drug125 mg/m2 IV on days 1, 8, 14 (every 28 days)
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Motixafortide, Cemiplimab, Gemcitabine, Nab-PaclitaxelExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Overall Response Rate (Complete Response (CR) + Partial Response (PR))
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.
Time frame
16 weeksSecondary outcomes
1
Incidence of Treatment Related Toxicities
All participants will be evaluable for toxicity from the time of their first treatment with the study drugs. The counts of treatment-related toxicities will be reported by type and severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.
Time frame
Up to 5 years2
Median Overall Survival
Overall survival is defined as the time from the date of first treatment with study drug to the time of death from any cause or last follow-up if alive.
Time frame
Up to 5 years3
Median Progression Free Survival
Progression free survival is defined as the time from first treatment with the study drug to the earliest of either disease progression or death from any cause.
Time frame
Up to 5 years4
Duration of Clinical Benefit
Duration of clinical benefit is defined as the time from first treatment with the study drug to the earliest of either disease progression or death from any cause in subjects who achieved a CR, PR, or stable disease (SD).
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Gulam Manji
Lead sponsor
Columbia University
Sponsor institution
Regeneron Pharmaceuticals
Collaborator
BioLine Rx
Collaborator
Source ClinicalTrials.gov