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NCT04543071 · ClinicalTrials.gov registry record · Phase 2
Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma
A Phase 2 study of Pancreatic Cancer and Adenocarcinoma, sponsored by Gulam Manji.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 3
- Study locations
NCT04543071: Recruiting Phase 2 study of Pancreatic Cancer and Adenocarcinoma, sponsored by Gulam Manji.
NCT04543071 is a Phase 2 study of Pancreatic Cancer and Adenocarcinoma that is actively recruiting participants, run by Gulam Manji. The registered enrollment target is 10 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (97% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04543071, a Phase 2 study of Pancreatic Cancer and Adenocarcinoma, is actively recruiting participants, sponsored by Gulam Manji.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Cemiplimab
- DRUG Gemcitabine
- DRUG Nab paclitaxel
- DRUG Motixafortide
Study Locations (3)
New York
- Columbia University Irving Medical Center - New York
Rhode Island
- Brown University - Providence
Wisconsin
- Medical College of Wisconsin, Wisconsin Diagnostic Labratories - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-11-09 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What NCT04543071 shows while recruiting
NCT04543071 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cemiplimab is the first listed.
NCT04543071 reports a single indexed study location in New York, Rhode Island, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04543071 about?
NCT04543071 is a clinical study titled "Chemo4METPANC Combination Chemokine Inhibitor, Immunotherapy, and Chemotherapy in Pancreatic Adenocarcinoma". 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 ...
What is the current status of trial NCT04543071?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2020-11-09. Estimated completion is 2028-08.
What conditions does trial NCT04543071 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Adenocarcinoma, Adenocarcinoma of the Pancreas.
What interventions are being tested in trial NCT04543071?
The interventions under investigation include: Cemiplimab (DRUG), Gemcitabine (DRUG), Nab paclitaxel (DRUG), Motixafortide (DRUG).
Who is sponsoring clinical trial NCT04543071?
This trial is sponsored by Gulam Manji, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04543071 being conducted?
This trial has 3 study locations across New York, Rhode Island, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04543071's enrollment target sits among peer trials
10 263rd of 278 higher than 12 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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