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

Phase 2

Recruiting

• Conditions: Adenocarcinoma; Adenocarcinoma of the Pancreas; Pancreatic Cancer
• Interventions: Drug: Motixafortide; Drug: Cemiplimab; Drug: Gemcitabine; Drug: Nab paclitaxel

• Registration Number: NCT04543071
• Lead Sponsor: Gulam Manji

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 tr...

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 ...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-09-08
• Study First Posted: 2020-09-09
• Study Start: 2020-11-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-07
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel	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.
Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel	Motixafortide	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.
Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel	Cemiplimab	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.
Motixafortide, Cemiplimab, Gemcitabine, Nab-Paclitaxel	Gemcitabine	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (Complete Response (CR) + Partial Response (PR))	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 Outcome Measures

Name	Time	Method
Incidence of Treatment Related Toxicities	Up to 5 years	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.
Median Overall Survival	Up to 5 years	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.
Median Progression Free Survival	Up to 5 years	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	Up to 5 years	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).
Disease Control Rate	16 weeks	The number of participants that achieve disease control rate (CR+PR+SD) by 16 weeks.

Trial Locations

Locations (2)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States