NCT04543071

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Gulam Manji · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Pancreatic Cancer
• Adenocarcinoma of the Pancreas
• Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Motixafortide	1.25 mg/kg subcutaneous (SC) monotherapy daily for 5 days during priming, followed by twice weekly
DRUG	Cemiplimab	350 mg intravenous (IV) once every 21 days
DRUG	Gemcitabine	1000 mg/m2 IV on days days 1, 8, 14 (every 28 days)
DRUG	Nab paclitaxel	125 mg/m2 IV on days 1, 8, 14 (every 28 days)

Timeline

• Start date: 2020-11-09
• Primary completion: 2028-06-01
• Completion: 2028-08-01
• First posted: 2020-09-09
• Last updated: 2025-06-19

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study