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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04166383
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vascular Biogenics (VB)-111 — BIOLOGICAL
    1E13 or 0.7E13 VP via intravenous (IV) infusion on Day 1 of cycle 1 and continue every 6 weeks
  • Nivolumab — DRUG
    240 mg of nivolumab via intravenous (IV) infusion on Day 1 of each cycle starting on cycle 2 and continue every 2 weeks

Study Details

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. ...

Key Dates

Start date
Aug 9, 2020
Status verified
Feb 2026
Primary completion
Apr 12, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1/Arm 1
    Vascular Biogenics (VB)-111 and nivolumab

Primary Outcome Measure

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 [ Time Frame: 90 days after treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

Find similar trials in Bethesda, MD

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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