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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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). 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. ...
Primary Outcome
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE)v5.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
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 |
Why NCT04166383 stopped before completion
NCT04166383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04166383 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04166383's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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