Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Immunomodulating Agents

Cemiplimab

Pancrelipase

Pancreatin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Antineoplastic Agents, Immunological

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.

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

Motixafortide

350 mg intravenous (IV) once every 21 days

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

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

Nab paclitaxel

Research Nurse Navigator

Gulam Manji, MD, PhD

Alexander Raufi, MD

Gulam Manji, MD,PhD

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.

Pancreas adenocarcinoma (PDAC) is an aggressive pancreatic cancer for which little progress has been made towards effective treatment. This is a Phase 2 open-label, multi-center study for patients with treatment-naïve metastatic PDAC. The goal of the study is to assess the preliminary efficacy of a CXCR4 antagonist (motixafortide), (cemiplimab), gemcitabine and nab-paclitaxel compared based on the response rate to historical controls in first line metastatic PDAC. Subjects will be treated with 5 days of motixafortide daily alone in the priming phase, followed by motixafortide twice a week, cemiplimab once every three weeks and and standard of care chemotherapy (gemcitabine and nabpaclitaxel).

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.

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

A Phase 2 Study With Combination Chemotherapy (Gemcitabine and Nab-Paclitaxel), Chemokine (C-X-C) Motif Receptor 4 Inhibitor (BL-8040), and Immune Checkpoint Blockade (Cemiplimab) in METastatic Treatment naïve PANCreas Adenocarcinoma

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.

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.

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.

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.

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).

The number of participants that achieve disease control rate (CR+PR+SD) by 16 weeks.

Spots Global Cancer Trial Database for motixafortide