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
Overview
- Phase
- Phase 2
- Intervention
- Motixafortide
- Conditions
- Pancreatic Cancer
- Sponsor
- Gulam Manji
- Enrollment
- 10
- Locations
- 3
- Primary Endpoint
- Overall Response Rate (Complete Response (CR) + Partial Response (PR))
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
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).
Investigators
Gulam Manji
Assistant Professor of Medicine
Columbia University
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel
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.
Intervention: Motixafortide
Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel
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.
Intervention: Cemiplimab
Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel
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.
Intervention: Gemcitabine
Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel
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.
Intervention: Nab paclitaxel
Outcomes
Primary Outcomes
Overall Response Rate (Complete Response (CR) + Partial Response (PR))
Time Frame: 16 weeks
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.
Secondary Outcomes
- 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)