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NCT03801915 · ClinicalTrials.gov registry record · Phase 2
Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers
A Phase 2 study of Pancreatic Cancer and Colon Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03801915: Completed Phase 2 study of Pancreatic Cancer and Colon Cancer, sponsored by National Cancer Institute (NCI).
NCT03801915 is a Phase 2 study of Pancreatic Cancer and Colon Cancer that has completed, run by National Cancer Institute (NCI). 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 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03801915, a Phase 2 study of Pancreatic Cancer and Colon Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. They want to learn the highest dose tolerated. They want to see if getting the agent at surgery helps slow down the disease. Objective: To test the safety of giving MVT-5873 at surgery to remove cancer and see if it slows the progression of the disease. Eligibility: Adults at least 18 years old with certain cancers and certain blood CA19-9 levels Design: Participants will be screened with: * Medical history * Physical exam * Blood and heart tests * Scans * Review of normal activities * Review of tumor sample * Pregnancy test A few days before surgery, participants will get a dose of the study agent. They will get it through a small plastic tube in a vein over about 2 hours. Participants will sign a separate consent and have the surgery. A sample of the tumor and normal liver will be removed for research. For 1-2 weeks after surgery, participants will recover in intensive care then regular care at the hospital. They will be monitored and treated throughout the stay. After leaving the hospital, participants will get the study agent every week for 1 month. Then they will get it every other week for 2 months. They will repeat screening tests at study visits and at a follow-up visit. That will be about 5 weeks after the last dose.
Primary Outcome
Disease recurrence is defined as new disease measurable on computed tomography (CT)/magnetic resonance imaging (MRI) that was not present on the baseline CT/MRI.
Conditions Studied
Interventions
- DRUG MVT-5873
- PROCEDURE pancreatectomy or hepatectomy
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2022-05-27 |
| Phase | Phase 2 |
What the finished NCT03801915 record still lists
NCT03801915 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 5 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which MVT-5873 is the first listed.
NCT03801915 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03801915 about?
NCT03801915 is a clinical study titled "Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers". Background: Gastrointestinal tumors have a molecule called carbohydrate antigen 19-9 (CA19-9) in the tumors and blood. The agent MVT-5873 was designed to block this molecule. Researchers want to test how safe it is to give this agent to people before and after surgery to remove a tumor. They want t...
What is the current status of trial NCT03801915?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2019-11-13. Estimated completion is 2022-05-27.
What conditions does trial NCT03801915 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Colon Cancer, Cholangiocarcinoma, Metastatic Colon Carcinoma, Liver Metastasis.
What interventions are being tested in trial NCT03801915?
The interventions under investigation include: MVT-5873 (DRUG), pancreatectomy or hepatectomy (PROCEDURE).
Who is sponsoring clinical trial NCT03801915?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03801915 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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