Trial Outcomes & Findings for VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC) (NCT NCT04166383)
NCT ID: NCT04166383
Last Updated: 2023-11-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
90 days after treatment
Results posted on
2023-11-08
Participant Flow
Participant milestones
| Measure |
Colorectal Cancers Metastasized to the Liver
Participants with colorectal cancers metastasized to the liver who received Vascular Biogenics (VB)-111 and nivolimab. Second biopsy: Cycle 2 Day 1. VB-111 will be given on Day 1 of cycle 1 and continue every 3 cycles (cycles 4, 7, 10 and so on) at a flat dose of 1x10\^13 or 0.7x10\^13 viral particles (VP). Nivolumab will be given on day 1 of every cycle starting at cycle 2 at a flat dose of 240 mg. Nivolumab will be administered over approximately 30-60 minutes via intravenous infusion.
TAC = Treatment Assignment Code
|
|---|---|
|
Drug Administration
STARTED
|
14
|
|
Drug Administration
COMPLETED
|
13
|
|
Drug Administration
NOT COMPLETED
|
1
|
|
TAC 1 - Second Biopsy Cycle 2 Day 1
STARTED
|
9
|
|
TAC 1 - Second Biopsy Cycle 2 Day 1
COMPLETED
|
7
|
|
TAC 1 - Second Biopsy Cycle 2 Day 1
NOT COMPLETED
|
2
|
|
TAC 2 - Second Biopsy Cycle 4 Day 1
STARTED
|
5
|
|
TAC 2 - Second Biopsy Cycle 4 Day 1
COMPLETED
|
4
|
|
TAC 2 - Second Biopsy Cycle 4 Day 1
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Colorectal Cancers Metastasized to the Liver
Participants with colorectal cancers metastasized to the liver who received Vascular Biogenics (VB)-111 and nivolimab. Second biopsy: Cycle 2 Day 1. VB-111 will be given on Day 1 of cycle 1 and continue every 3 cycles (cycles 4, 7, 10 and so on) at a flat dose of 1x10\^13 or 0.7x10\^13 viral particles (VP). Nivolumab will be given on day 1 of every cycle starting at cycle 2 at a flat dose of 240 mg. Nivolumab will be administered over approximately 30-60 minutes via intravenous infusion.
TAC = Treatment Assignment Code
|
|---|---|
|
Drug Administration
Prior to treatment (tx), had a medical emergency requiring surgery & was unable to have further tx.
|
1
|
|
TAC 1 - Second Biopsy Cycle 2 Day 1
Did not complete 2nd biopsy.
|
2
|
|
TAC 2 - Second Biopsy Cycle 4 Day 1
Did not complete 2nd biopsy.
|
1
|
Baseline Characteristics
VB-111 in Combination With Nivolumab in People With Metastatic Colorectal Cancer (mCRC)
Baseline characteristics by cohort
| Measure |
Colorectal Cancers Metastasized to the Liver
n=14 Participants
Participants with colorectal cancers metastasized to the liver who received Vascular Biogenics (VB)-111 and nivolimab. Second biopsy: Cycle 2 Day 1. VB-111 will be given on Day 1 of cycle 1 and continue every 3 cycles (cycles 4, 7, 10 and so on) at a flat dose of 1x10\^13 or 0.7x10\^13 viral particles (VP). Nivolumab will be given on day 1 of every cycle starting at cycle 2 at a flat dose of 240 mg. Nivolumab will be administered over approximately 30-60 minutes via intravenous infusion.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
|
Age, Continuous
|
52.87 years
STANDARD_DEVIATION 10.21 • n=93 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 90 days after treatmentPopulation: One participant never treated with study drugs.
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.
Outcome measures
| Measure |
Grade 1 Possibly Related
n=13 Participants
Grade 1 is mild.
|
Grade 1 Probably Related
n=13 Participants
Grade 1 is mild.
|
Grade 1 Definitely Related
n=13 Participants
Grade 1 is mild.
|
Grade 2 Possibly Related
n=13 Participants
Grade 2 is moderate.
|
Grade 2 Probably Related
n=13 Participants
Grade 2 is moderate.
|
Grade 2 Definitely Related
n=13 Participants
Grade 2 is moderate.
|
Grade 3 Possibly Related
n=13 Participants
Grade 3 is severe.
|
Grade 3 Probably Related
n=13 Participants
Grade 3 is severe.
|
Grade 3 Definitely Related
n=13 Participants
Grade 3 is severe.
|
Grade 4 Possibly Related
n=13 Participants
Grade 4 is life-threatening.
|
Grade 4 Probably Related
n=13 Participants
Grade 4 is life-threatening.
|
Grade 4 Definitely Related
n=13 Participants
Grade 4 is life-threatening.
|
Grade 5 Possibly Related
n=13 Participants
Grade 5 is death related to adverse event.
|
Grade 5 Probably Related
n=13 Participants
Grade 5 is death related to adverse event.
|
Grade 5 Definitely Related
n=13 Participants
Grade 5 is death related to adverse event.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
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
Activated partial thromboplastin time prolonged
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Anorexia
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Chills
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Diarrhea
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Fatigue
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Fever
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Flu like symptoms
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Headache
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Hypoxia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Lymphocyte count decreased
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Mucositis oral
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Nausea
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Respiratory, thoracic and mediastinal disorders - Other, tachypnea
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Sinus tachycardia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
White blood cell decreased
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
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
Vomiting
|
0 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Follow up visits are planned to be performed at 60 (+/- 14 days) and 90 (+/- 14 days) days after treatment discontinuation to evaluate patient's safety, up to 6 months.Population: One participant not evaluable
Best overall response is defined as the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started) assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
Outcome measures
| Measure |
Grade 1 Possibly Related
n=13 Participants
Grade 1 is mild.
|
Grade 1 Probably Related
Grade 1 is mild.
|
Grade 1 Definitely Related
Grade 1 is mild.
|
Grade 2 Possibly Related
Grade 2 is moderate.
|
Grade 2 Probably Related
Grade 2 is moderate.
|
Grade 2 Definitely Related
Grade 2 is moderate.
|
Grade 3 Possibly Related
Grade 3 is severe.
|
Grade 3 Probably Related
Grade 3 is severe.
|
Grade 3 Definitely Related
Grade 3 is severe.
|
Grade 4 Possibly Related
Grade 4 is life-threatening.
|
Grade 4 Probably Related
Grade 4 is life-threatening.
|
Grade 4 Definitely Related
Grade 4 is life-threatening.
|
Grade 5 Possibly Related
Grade 5 is death related to adverse event.
|
Grade 5 Probably Related
Grade 5 is death related to adverse event.
|
Grade 5 Definitely Related
Grade 5 is death related to adverse event.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Best Overall Response (BOR)
Complete Response
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response (BOR)
Partial Response
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response (BOR)
Progressive Disease
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Best Overall Response (BOR)
Stable Disease
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The time between the first day of treatment to the day of disease progression, an average of 1.8 months.Population: One participant never treated with study drugs.
Progression-free survival was assessed by the Kaplan-Meier technique with GraphPad Prism 9.3.1 for Windows (GraphPad, San Diego, CA) to calculate these values, and the median PFS will be reported along with 95% confidence interval. PFS is defined as the time between the first day of treatment to the day of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
Outcome measures
| Measure |
Grade 1 Possibly Related
n=13 Participants
Grade 1 is mild.
|
Grade 1 Probably Related
Grade 1 is mild.
|
Grade 1 Definitely Related
Grade 1 is mild.
|
Grade 2 Possibly Related
Grade 2 is moderate.
|
Grade 2 Probably Related
Grade 2 is moderate.
|
Grade 2 Definitely Related
Grade 2 is moderate.
|
Grade 3 Possibly Related
Grade 3 is severe.
|
Grade 3 Probably Related
Grade 3 is severe.
|
Grade 3 Definitely Related
Grade 3 is severe.
|
Grade 4 Possibly Related
Grade 4 is life-threatening.
|
Grade 4 Probably Related
Grade 4 is life-threatening.
|
Grade 4 Definitely Related
Grade 4 is life-threatening.
|
Grade 5 Possibly Related
Grade 5 is death related to adverse event.
|
Grade 5 Probably Related
Grade 5 is death related to adverse event.
|
Grade 5 Definitely Related
Grade 5 is death related to adverse event.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Progression-free Survival (PFS)
|
1.8 Months
Interval 0.75 to 2.72
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The time between the first day of treatment to the day of death, an average of 6.9 months.Overall survival was assessed by the Kaplan-Meier technique with GraphPad Prism 9.3.1 for Windows (GraphPad, San Diego, CA) to calculate these values, and the median OS will be reported along with 95% confidence intervals. Overall survival is the time between the first day of treatment to the day of death.
Outcome measures
| Measure |
Grade 1 Possibly Related
n=13 Participants
Grade 1 is mild.
|
Grade 1 Probably Related
Grade 1 is mild.
|
Grade 1 Definitely Related
Grade 1 is mild.
|
Grade 2 Possibly Related
Grade 2 is moderate.
|
Grade 2 Probably Related
Grade 2 is moderate.
|
Grade 2 Definitely Related
Grade 2 is moderate.
|
Grade 3 Possibly Related
Grade 3 is severe.
|
Grade 3 Probably Related
Grade 3 is severe.
|
Grade 3 Definitely Related
Grade 3 is severe.
|
Grade 4 Possibly Related
Grade 4 is life-threatening.
|
Grade 4 Probably Related
Grade 4 is life-threatening.
|
Grade 4 Definitely Related
Grade 4 is life-threatening.
|
Grade 5 Possibly Related
Grade 5 is death related to adverse event.
|
Grade 5 Probably Related
Grade 5 is death related to adverse event.
|
Grade 5 Definitely Related
Grade 5 is death related to adverse event.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Overall Survival (OS)
|
6.9 Months
Interval 2.64 to 10.74
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: One participant not analyzed as they never received study drug.
6-month progression-free survival was assessed by the Kaplan-Meier technique with GraphPad Prism 9.3.1 for Windows (GraphPad, San Diego, CA) to calculate these values, and the median PFS will be reported along with 95% confidence interval. PFS is defined as the time between the first day of treatment to the day of disease progression. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.1. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
Outcome measures
| Measure |
Grade 1 Possibly Related
n=13 Participants
Grade 1 is mild.
|
Grade 1 Probably Related
Grade 1 is mild.
|
Grade 1 Definitely Related
Grade 1 is mild.
|
Grade 2 Possibly Related
Grade 2 is moderate.
|
Grade 2 Probably Related
Grade 2 is moderate.
|
Grade 2 Definitely Related
Grade 2 is moderate.
|
Grade 3 Possibly Related
Grade 3 is severe.
|
Grade 3 Probably Related
Grade 3 is severe.
|
Grade 3 Definitely Related
Grade 3 is severe.
|
Grade 4 Possibly Related
Grade 4 is life-threatening.
|
Grade 4 Probably Related
Grade 4 is life-threatening.
|
Grade 4 Definitely Related
Grade 4 is life-threatening.
|
Grade 5 Possibly Related
Grade 5 is death related to adverse event.
|
Grade 5 Probably Related
Grade 5 is death related to adverse event.
|
Grade 5 Definitely Related
Grade 5 is death related to adverse event.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
6-month Progression-free Survival (PFS)
|
NA Months
No participants progressed in 6 months.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, an average of 28 months and 23 days.Population: One participant never received study drugs.
Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
Grade 1 Possibly Related
n=13 Participants
Grade 1 is mild.
|
Grade 1 Probably Related
Grade 1 is mild.
|
Grade 1 Definitely Related
Grade 1 is mild.
|
Grade 2 Possibly Related
Grade 2 is moderate.
|
Grade 2 Probably Related
Grade 2 is moderate.
|
Grade 2 Definitely Related
Grade 2 is moderate.
|
Grade 3 Possibly Related
Grade 3 is severe.
|
Grade 3 Probably Related
Grade 3 is severe.
|
Grade 3 Definitely Related
Grade 3 is severe.
|
Grade 4 Possibly Related
Grade 4 is life-threatening.
|
Grade 4 Probably Related
Grade 4 is life-threatening.
|
Grade 4 Definitely Related
Grade 4 is life-threatening.
|
Grade 5 Possibly Related
Grade 5 is death related to adverse event.
|
Grade 5 Probably Related
Grade 5 is death related to adverse event.
|
Grade 5 Definitely Related
Grade 5 is death related to adverse event.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
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Adverse Events
Colorectal Cancers Metastasized to the Liver
Serious events: 1 serious events
Other events: 13 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Colorectal Cancers Metastasized to the Liver
n=14 participants at risk
Participants with colorectal cancers metastasized to the liver who received Vascular Biogenics (VB)-111 and nivolimab. Second biopsy: Cycle 2 Day 1. VB-111 will be given on Day 1 of cycle 1 and continue every 3 cycles (cycles 4, 7, 10 and so on) at a flat dose of 1x10\^13 or 0.7x10\^13 viral particles (VP). Nivolumab will be given on day 1 of every cycle starting at cycle 2 at a flat dose of 240 mg. Nivolumab will be administered over approximately 30-60 minutes via intravenous infusion.
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|---|---|
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Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, Spleen infarction
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Investigations
Lipase increased
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Gastrointestinal disorders
Pancreatitis
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Investigations
Platelet count decreased
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Hepatobiliary disorders
Portal vein thrombosis
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Injury, poisoning and procedural complications
Postoperative hemorrhage
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Investigations
Serum amylase increased
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Infections and infestations
Soft tissue infection
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
Other adverse events
| Measure |
Colorectal Cancers Metastasized to the Liver
n=14 participants at risk
Participants with colorectal cancers metastasized to the liver who received Vascular Biogenics (VB)-111 and nivolimab. Second biopsy: Cycle 2 Day 1. VB-111 will be given on Day 1 of cycle 1 and continue every 3 cycles (cycles 4, 7, 10 and so on) at a flat dose of 1x10\^13 or 0.7x10\^13 viral particles (VP). Nivolumab will be given on day 1 of every cycle starting at cycle 2 at a flat dose of 240 mg. Nivolumab will be administered over approximately 30-60 minutes via intravenous infusion.
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|---|---|
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Gastrointestinal disorders
Abdominal distension
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Gastrointestinal disorders
Abdominal pain
|
35.7%
5/14 • Number of events 7 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
57.1%
8/14 • Number of events 14 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Investigations
Alanine aminotransferase increased
|
21.4%
3/14 • Number of events 4 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Investigations
Alkaline phosphatase increased
|
50.0%
7/14 • Number of events 10 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Blood and lymphatic system disorders
Anemia
|
57.1%
8/14 • Number of events 21 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Metabolism and nutrition disorders
Anorexia
|
35.7%
5/14 • Number of events 6 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Gastrointestinal disorders
Ascites
|
21.4%
3/14 • Number of events 4 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Investigations
Aspartate aminotransferase increased
|
35.7%
5/14 • Number of events 8 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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Musculoskeletal and connective tissue disorders
Back pain
|
21.4%
3/14 • Number of events 4 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Gastrointestinal disorders
Bloating
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Investigations
Blood bilirubin increased
|
42.9%
6/14 • Number of events 9 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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General disorders
Chills
|
28.6%
4/14 • Number of events 5 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Psychiatric disorders
Confusion
|
7.1%
1/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Gastrointestinal disorders
Constipation
|
21.4%
3/14 • Number of events 6 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
4/14 • Number of events 5 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Investigations
Creatinine increased
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Metabolism and nutrition disorders
Dehydration
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Psychiatric disorders
Depression
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Number of events 3 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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Nervous system disorders
Dizziness
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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Skin and subcutaneous tissue disorders
Dry skin
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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Respiratory, thoracic and mediastinal disorders
Dyspnea
|
21.4%
3/14 • Number of events 4 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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General disorders
Edema limbs
|
21.4%
3/14 • Number of events 3 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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Infections and infestations
Enterocolitis infectious
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Reproductive system and breast disorders
Erectile dysfunction
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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General disorders
Fatigue
|
78.6%
11/14 • Number of events 16 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Gastrointestinal disorders
Fecal incontinence
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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General disorders
Fever
|
35.7%
5/14 • Number of events 14 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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General disorders
Flu like symptoms
|
42.9%
6/14 • Number of events 9 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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Nervous system disorders
Headache
|
28.6%
4/14 • Number of events 4 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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|
Renal and urinary disorders
Hematuria
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Metabolism and nutrition disorders
Hypercalcemia
|
21.4%
3/14 • Number of events 3 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
28.6%
4/14 • Number of events 4 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
42.9%
6/14 • Number of events 10 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
42.9%
6/14 • Number of events 10 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.4%
3/14 • Number of events 6 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • Number of events 3 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Investigations
Lymphocyte count decreased
|
50.0%
7/14 • Number of events 17 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Investigations
Lymphocyte count increased
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
General disorders
Malaise
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Gastrointestinal disorders
Mucositis oral
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, Soreness in shoulder
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Gastrointestinal disorders
Nausea
|
57.1%
8/14 • Number of events 11 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
General disorders
Neck edema
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Investigations
Platelet count decreased
|
35.7%
5/14 • Number of events 8 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Gastrointestinal disorders
Rectal pain
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, Tachypnea
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Cardiac disorders
Sinus tachycardia
|
42.9%
6/14 • Number of events 13 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Rash
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Renal and urinary disorders
Urinary incontinence
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
|
Renal and urinary disorders
Urinary urgency
|
7.1%
1/14 • Number of events 1 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Gastrointestinal disorders
Vomiting
|
64.3%
9/14 • Number of events 12 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Investigations
Weight loss
|
14.3%
2/14 • Number of events 4 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
|
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Investigations
White blood cell decreased
|
14.3%
2/14 • Number of events 2 • Date treatment consent signed to date off study, an average of 28 months and 23 days.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place