RecruitingPhase 2NCT04543071

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

Sponsor

Gulam Manji

Enrollment

10 participants

Start Date

Nov 9, 2020

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer Adenocarcinoma Adenocarcinoma of the Pancreas

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — a chemokine inhibitor (to disrupt the tumor's protective environment), an immunotherapy drug, and standard chemotherapy — for patients with metastatic pancreatic cancer (cancer that has spread beyond the pancreas). **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of metastatic (stage IV) pancreatic adenocarcinoma - You have not received prior treatment for your metastatic disease - Your overall health is good (ECOG score 0–1) - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have a different type of pancreatic cancer (endocrine or acinar) - You have received prior chemotherapy or immunotherapy for this cancer - You have uncontrolled infections, autoimmune disease, or significant heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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