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Checkpoint Inhibitor

1/Arm 1 for Colorectal Cancer

Phase 2

Waitlist Available

Led By Tim F Greten, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing a combination of VB-111 and nivolumab to see if it is safe and will cause colorectal tumors to shrink. Eligible participants must have microsatellite stable colorectal cancer that has spread to the liver.

Eligible Conditions

Colorectal Cancer
Colorectal Tumor

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Overall Response (BOR)

Number of Participants With Grade 1, Grade 2, Grade 3, Grade 4, and/or Grade 5 Adverse Events That Are Possibly, Probably and/or Definitely Related to Drug

Secondary outcome measures

6-month Progression-free Survival (PFS)

Median Overall Survival (OS)

Median Progression-free Survival (PFS)

Other outcome measures

Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/Arm 1Experimental Treatment2 Interventions

Vascular Biogenics (VB)-111 and nivolumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vascular Biogenics (VB)-111

2020

Completed Phase 2

~20

Nivolumab

2014

Completed Phase 3

~4750

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,867 Total Patients Enrolled

Tim F Greten, M.D.Principal InvestigatorNational Cancer Institute (NCI)

20 Previous Clinical Trials

1,451 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are the doctors testing this medication on?

"Trial recruitment for this study has ceased. The trial was posted on 8/9/2020 and last updated on 10/4/2022. There are presently 1125 clinical trials actively admitting patients with colorectal cancer and 749 studies for VB-111 actively recruiting participants that you may be eligible for."

Answered by AI

Does this particular experiment have any historical precedence?

"VB-111 has a long history, with the first study being performed in 2010. Sponsored by Medarex, this initial research involved 127 individuals. After Phase 1 approval was received, there are now 749 live trials for VB-11 taking place across 2353 cities and 50 countries."

Answered by AI

What is the latest news on VB-111's progress in being accepted by the FDA?

"VB-111 scored a 2 on our team's safety scale at Power. This is because, while there have been Phase 2 trials conducted which support its safety, there is no data yet to suggest that it is an effective medication."

Answered by AI

Are there any other published reports on VB-111?

"VB-111 is being trialed in 83 phase 3 clinical trials, 749 total. The global scope of these medical studies is large, with 40421 locations running VB-111 trials."

Answered by AI

For what disorders is VB-111 commonly prescribed?

"VB-111 is often used as a treatment for malignant neoplasms. Additionally, VB-111 has been shown to be an effective method of treating unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

Are there any available slots for patients who want to participate in this trial?

"According to information on clinicaltrials.gov, this study is no longer recruiting patients for participation. The trial was originally posted on 8/9/2020 and experienced its last update on 10/4/2022. Although this research project is not looking for any more participants, there are currently 1,874 other trials which are actively seeking patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC)

Tim Greten, M.D. 2020. "VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04166383.