Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma

NCT04543071 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: AAAS9513
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pancreatic Cancer; Adenocarcinoma of the Pancreas; Adenocarcinoma

Outcome Measures

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.

  16 weeks

Secondary Outcomes (5)

• Incidence of Treatment Related Toxicities

  Up to 5 years

• Median Overall Survival

  Up to 5 years

• Median Progression Free Survival

  Up to 5 years

• Duration of Clinical Benefit

  Up to 5 years

• Disease Control Rate

  16 weeks

Study Arms (1)

Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel

EXPERIMENTAL

Participants will receive standard FDA-approved doses of gemcitabine and nab-paclitaxel for pancreas cancer and cemiplimab at the dose that is approved for participants with skin cancer. Participants will also receive motixafortide at a dose that has been deemed safe in previous studies when used in combination with immunotherapy and chemotherapy. If the combination study treatment causes a serious side effect in participants, the study treatment will be modified.

Drug: Motixafortide; Drug: Cemiplimab; Drug: Gemcitabine; Drug: Nab paclitaxel

Interventions

Motixafortide DRUG

1.25 mg/kg subcutaneous (SC) monotherapy daily for 5 days during priming, followed by twice weekly

Also known as: BL-8040

Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel

Cemiplimab DRUG

350 mg intravenous (IV) once every 21 days

Also known as: REGN2810

Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel

Gemcitabine DRUG

1000 mg/m2 IV on days days 1, 8, 14 (every 28 days)

Also known as: Gemzar

Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel

Nab paclitaxel DRUG

125 mg/m2 IV on days 1, 8, 14 (every 28 days)

Also known as: Abraxane

Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Age ≥18 years
• Adequate hematological and end-organ function (test results from within 14 days prior to initiation of study treatment):
• Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L without granulocyte colony-stimulating factor support
• White Blood Cell Count (WBC) count ≥ 2.5 x 109 /L (2500/uL)
• Lymphocyte count ≥ 0.5 x 109/L (500/uL)
• Platelet count ≥ 100 x 109/L (100,000/uL) without transfusion
• Hgb ≥ 9.0 g/dL
• Aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) ≤ 2.5X upper limit of normal (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

You may not qualify if:

• 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
• Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 or better, with the exception of alopecia of any grade and Grade ≤ 2 peripheral neuropathy
• Concomitant treatment with other anti-neoplastic agents (hormone therapy acceptable)
• Uncontrolled pleural effusion, pericardial effusion, or ascites. Subjects who required drainage within the four weeks prior or require pleural, pericardial, or peritoneal catheters for drainage are ineligible.
• Uncontrolled tumor-related pain Patients requiring narcotic pain medication must be on a stable regimen for at least two weeks prior to study entry.
• History of leptomeningeal or brain/ Central Nervous System (CNS) metastases
• Uncontrolled hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL, or corrected serum calcium \> upper limit of normal) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy.
• Recent major surgery or significant traumatic injury Participants may not have undergone major surgery or experienced significant traumatic injury within 14 days prior to initiating study treatment, or be recovering from procedure related adverse events of \> Grade 1.
• Active or history of autoimmune disease or immune deficiency Includes, but is not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
• Patients with a history of autoimmune-related hypothyroidism who are on stable thyroid-replacement hormone for the past three months are eligible for the study.
• Patients with controlled Type 1 diabetes mellitus who are on a stable insulin regimen for the past month are eligible for the study.
• Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

Sponsors & Collaborators

• Gulam Manji: lead
• Regeneron Pharmaceuticals: collaborator
• BioLine Rx: collaborator

Study Sites (3)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

Brown University

Providence, Rhode Island, 02912, United States

RECRUITING

Medical College of Wisconsin, Wisconsin Diagnostic Labratories

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Adenocarcinoma

Interventions

4-fluorobenzoyl-TN-14003; cemiplimab; Gemcitabine; Taxes; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Gulam Manji, MD,PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

212-342-5162; cancerclinicaltrials@cumc.columbia.edu

Gulam Manji, MD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: The study will use a Simon optimal 2-stage design. The study will enroll 10 participants in the first stage. If 3 or more participants meet the endpoint in the first stage, the study will be expanded to a total of 40 participants. If a total of 14 or more participants achieve CR or PR by 16 weeks weeks, the agents will warrant further study.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: September 9, 2020
• Study Start: November 9, 2020
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (3)