OncoMatch/Clinical Trials/NCT04543071
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
Is NCT04543071 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Motixafortide and Cemiplimab for pancreatic cancer.
Treatment: Motixafortide · Cemiplimab · Gemcitabine · Nab paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
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.
Cannot have received: investigational therapy
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.
Cannot have received: checkpoint inhibitor
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.
Cannot have received: radiation therapy
Exception: except for palliation for pain; not within two weeks prior to initiation of study treatment; not to primary pancreas lesion or a metastatic site except for palliation for pain; not to 25% or more of the bone marrow
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.
Cannot have received: surgery
Prior surgery for PDAC Participants may not have had surgical resection of PDAC prior to initiation of study treatment
Lab requirements
Blood counts
ANC ≥ 1.5 x 10^9/L without granulocyte colony-stimulating factor support; WBC ≥ 2.5 x 10^9/L; Lymphocyte count ≥ 0.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L without transfusion; Hgb ≥ 9.0 g/dL; INR and aPTT ≤ 1.5X ULN, except for those on stable anticoagulation for at least two weeks
Kidney function
Creatinine within ULN or calculated creatinine clearance (CrCl) >50 mL/min using the Cockcroft-Gault formula
Liver function
AST, ALT, and ALP ≤ 2.5X ULN, unless elevated secondary to biliary obstruction from the pancreas mass and amenable to decompression prior to initiation of therapy; Serum total bilirubin ≤ 1.5X ULN, unless in patients with known Gilbert disease (≤ 3X ULN), or unless elevated secondary to biliary obstruction from the pancreas mass and amenable to decompression prior to administration of investigational therapy; Albumin ≥ 3.5 g/dL
Cardiac function
Left ventricular ejection fraction below institutional lower limit of normal or below 50%, whichever is lower; Baseline QTcF ≥ 450 ms (males) or ≥ 470 ms (females)
Adequate hematological and end-organ function (test results from within 14 days prior to initiation of study treatment): ... see full details above
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Columbia University Irving Medical Center · New York, New York
- Brown University · Providence, Rhode Island
- Medical College of Wisconsin, Wisconsin Diagnostic Labratories · Milwaukee, Wisconsin
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