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
Qualifiers
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
Treatments tested in this trial
- Motixafortide
- Cemiplimab
- Gemcitabine
- Nab paclitaxel
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Gulam Manji
Lead sponsor
Columbia University
Sponsor institution
Regeneron Pharmaceuticals
Collaborator
BioLine Rx
Collaborator
Source ClinicalTrials.gov