Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04543071|
Recruitment Status : Recruiting
First Posted : September 9, 2020
Last Update Posted : November 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Adenocarcinoma of the Pancreas Adenocarcinoma||Drug: Motixafortide Drug: Cemiplimab Drug: Gemcitabine Drug: Nab paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||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|
|Actual Study Start Date :||November 9, 2020|
|Estimated Primary Completion Date :||July 2025|
|Estimated Study Completion Date :||August 2025|
Experimental: 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.
1.25 mg/kg subcutaneous (SC) monotherapy daily for 5 days during priming, followed by twice weekly
Other Name: BL-8040
350 mg intravenous (IV) once every 21 days
Other Name: REGN2810
1000 mg/m2 IV on days days 1, 8, 14 (every 28 days)
Other Name: Gemzar
Drug: Nab paclitaxel
125 mg/m2 IV on days 1, 8, 14 (every 28 days)
Other Name: Abraxane
- 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.
- Incidence of Treatment Related Toxicities [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 16 weeks ]The number of participants that achieve disease control rate (CR+PR+SD) by 16 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04543071
|Contact: Research Nurse Navigatorfirstname.lastname@example.org|
|Contact: Gulam Manji, MD, PhD|
|United States, New York|
|Columbia University Irving Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Research Nurse Navigator 212-342-5162 email@example.com|
|Principal Investigator: Gulam Manji, MD, PhD|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02912|
|Contact: Alexander Raufi, MD 844-222-2881 ARaufi@Lifespan.org|
|Principal Investigator: Alexander Raufi, MD|
|Principal Investigator:||Gulam Manji, MD,PhD||Columbia University|