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NCT04166383 · ClinicalTrials.gov registry record · Phase 2
VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC)
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT04166383: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT04166383 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 14 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04166383, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
Background: Gastrointestinal cancer is one of the most common cancers worldwide. Researchers think an unmet need exists to understand and improve treatment options. They want to see if a combination of drugs can help people with metastatic colorectal cancer. Objective: To see if using a combination of Vascular Biogenics (VB)-111 and nivolumab is safe and will cause colorectal tumors to shrink. Eligibility: People ages 18 and older with microsatellite stable colorectal cancer that has spread to the liver Design: Participants must consent to sample collection protocol 11C0112. Participants will be screened with: Blood tests Scans Tumor samples. If these are not available, participants will have a biopsy. Before they start treatment and with every treatment cycle, participants will have: Physical exams Blood tests Heart tests Before they start treatment and every 4 cycles, participants will have computed tomography (CT) or magnetic resonance imaging (MRI) scans. For these, they will lie in a machine that takes pictures of the body. For the MRI, a soft padding or coil will be placed around their head. Participants will have biopsies before they start therapy. They will have them again after 2 6 weeks on study. On day 1 of 14-day cycles, participants will get one or both study drugs by vein. After they finish treatment, participants will have monthly visits for 3 months. They will have a physical exam and blood tests. If participants stop treatment for reasons other than their disease getting worse, they will have scans about every 8 weeks. This will continue until their disease gets worse. Participants will be contacted by phone or email every 6 months. This will continue for life. ...
Interventions
- DRUG Nivolumab
- BIOLOGICAL Vascular Biogenics (VB)-111
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-08-09 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04166383
The ClinicalTrials.gov registry entry for NCT04166383 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04166383 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04166383 about?
NCT04166383 is a clinical study titled "VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC)". Background: Gastrointestinal cancer is one of the most common cancers worldwide. Researchers think an unmet need exists to understand and improve treatment options. They want to see if a combination of drugs can help people with metastatic colorectal cancer. Objective: To see if using a combinati...
What is the current status of trial NCT04166383?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2020-08-09. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT04166383?
The interventions under investigation include: Nivolumab (DRUG), Vascular Biogenics (VB)-111 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04166383?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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