Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Patients With Pancreatic Adenocarcinoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Adenocarcinoma
- Adenocarcinoma of the Pancreas
- Pancreatic Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: 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.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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).
Tracking Information
- NCT #
- NCT04543071
- Collaborators
- Regeneron Pharmaceuticals
- BioLine Rx
- Investigators
- Principal Investigator: Gulam Manji, MD,PhD Columbia University
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