NCT02179515 is a Phase 1 clinical trial of MVA-brachyury- TRICOM in Lung Cancer, sponsored by National Cancer Institute (NCI).

Who is sponsoring NCT02179515?

NCT02179515 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT02179515?

Interventions in NCT02179515: MVA-brachyury- TRICOM.

What condition does NCT02179515 study?

NCT02179515 studies Lung Cancer, Breast Cancer, Prostate Cancer, Tumors (Others), Ovarian Cancer.

Is NCT02179515 still recruiting?

NCT02179515 is currently completed. Last updated 26 January 2021.

Are results published for NCT02179515?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-01-26 · How we verify

NCT02179515

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Tolerability of a Modified Vaccinia Ankara (MVA)-Based Vaccine Modified to Express Brachyury and T-cell Costimulatory Molecules (MVA-Brachyury-TRICOM)

Completed Phase 1 Results posted Last updated 26 January 2021

What this trial tests

Phase 1 trial testing MVA-brachyury- TRICOM in Lung Cancer in 38 participants. Completed in 28 February 2018.

Timeline

28 June 2014

Primary endpoint
6 April 2017

28 February 2018

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	28 June 2014
Primary completion	6 April 2017
Estimated completion	28 February 2018
Sites	1 location across United States

Drugs / interventions tested

MVA-brachyury- TRICOM — full drug profile →

Conditions studied

Lung Cancer — all drugs for Lung Cancer →
Breast Cancer — all drugs for Breast Cancer →
Prostate Cancer — all drugs for Prostate Cancer →
Tumors (Others) — all drugs for Tumors (Others) →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 100, any sex, with Lung Cancer or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) Primary · Date treatment consent signed to date off study, approximately 9 months and 6 days for DL1, 17 months and 3 days for DL2, and 23 months and 13 days for DL3.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). 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

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	3
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	14
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	17

Number of Participants With Dose-Limiting Toxicities (DLT) Primary · 28 days following the first injection of vaccine.

Dose-limiting toxicity (DLT) will be defined as any one of the following: Any grade ≥ 3 hematologic toxicity or grade ≥ 3 non-hematologic toxicity that is possibly, probably, or definitely related to study drug, except transient (≤ 48 hour) grade 3 fatigue, local reactions, flu-like symptoms, fever, headache, and laboratory abnormalities that are not associated with organ pathology. Also any ≥ grade 2 allergic and ≥ grade 2 autoimmune reaction(s) (except endocrine-related immune toxicity) will be defined as a DLT. Any grade 3 autoimmune endocrine-related toxicity that has not resolved clinical

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0

Maximum Tolerated Dose (MTD) Primary · First 28 days of treatment.

The MTD will be the dose level at which no greater than 1/6 patients have a dose-limiting toxicity (DLT), and the next higher dose level has at least 2 patients with a DLT.

Group	Value	95% CI
All Participants	NA

Number of Participants With Grade 3 or Greater Adverse Events Possibly Related to Vaccine Primary · Date treatment consent signed to date off study, approximately 9 months and 6 days for DL1, 17 months and 3 days for DL2, and 23 months and 13 days for DL3.

Number of participants with Grade 3 or greater adverse events possibly related to vaccine assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 3 is severe or medically significant but not immediately life-threatening. Grade 4 is life threatening consequences, and Grade 5 is death related to adverse event.

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0

Number of Participants With Brachyury-Specific T-cell Responses Developed After 1, 2, and 3 Vaccinations Secondary · Baseline (pre-vaccination), approximately day 29 (after 1 vaccination), approximately day 57 (after 2 vaccinations), and approximately day 85 (after 3 vaccinations)

A fluorescence activated cell sorting (FACS)-based assay for cluster of differentiation 4 (CD4) or cluster of differentiation 8 (CD8) T-cells expressing the cytokines interferon (IFN) gamma, interleukin 2 (IL2), and tumor necrosis factor (TNF) alpha, and/or cluster of differentiation 107a (CD107a) (a marker for lytic potential) was used to determine the numbers of participants showing development or enhancement of the level of brachyury-specific T-cells after vaccination.

CD107a + CD4 T-cell response (d29 vs pre)

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	4
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0

IFN gamma + CD4 T-cell response (d29 vs pre)

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	1
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	2
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	1

IL2 + CD4 T-cell response (d29 vs pre)

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	1
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0

TNF alpha + CD4 T-cell response (d29 vs pre)

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	4
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0

CD107a + CD8 T-cell response (d29 vs pre)

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	1
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0

IFN gamma + CD8 T-cell response (d29 vs pre)

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	6
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0

IL2 + CD8 T-cell response (d29 vs pre)

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0

TNF alpha + CD8 T-cell response (d29 vs pre)

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	1
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	4
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0

Percentage of Total Peripheral Blood Mononuclear Cells (PBMCs) in Peripheral Blood Before Vaccination, and After 1 and 3 Vaccinations Secondary · Pre (Baseline), and approximately D29 (Post 1 vaccination) and D85 (post 3 vaccinations)

Blood samples collected were analyzed by multicolor flow cytometry in PBMCs for cluster of differentiation 4 (CD4), cluster of differentiation 8 (CD8), Natural Killer (NK), Natural Killer T (NKT), conventional dendritic cell (cDC), plasmacytoid dendritic cell (pDC), myeloid-derived suppressor cell (MDSC) and Tregs. Changes in levels PBMC subsets was a descriptive result with median and interquartile range reported. No formal statistical analysis by dose level was performed given the small sample size.

CD4 Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	24.31	14.78 – 38.24
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	32.64	27.63 – 40.74
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	32.89	22.61 – 37.37

CD4 D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	23.68	13.15 – 36.09
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	34.99	23.61 – 39.35
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	29.86	20.99 – 36.08

CD4 D85

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	27.70	13.09 – 39.84
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	30.35	25.55 – 36.67
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	29.87	25.77 – 36.65

CD8 Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	7.51	4.90 – 14.31
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	16.85	10.20 – 23.58
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	12.27	9.28 – 16.34

CD8 D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	7.83	3.73 – 13.43
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	16.28	9.55 – 24.45
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	10.96	9.18 – 17.43

CD8 D85

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	10.92	5.71 – 13.99
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	17.17	12.29 – 26.14
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	13.99	11.78 – 20.43

Treg Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	2.19	1.00 – 2.41
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1.50	1.21 – 1.93
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	1.07	0.77 – 1.53

Treg D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	1.71	1.23 – 1.98
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1.40	1.20 – 1.78
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	1.34	0.88 – 1.65

Number of Participants With Positive Anti-Brachyury Antibodies Secondary · Pre (Baseline), and approximately D29 (Post 1 vaccination), D57 (post 2 vaccinations) and D85 (post 3 vaccinations)

A positive brachyury antibody titer consisted of an absorbance to brachyury protein that was twice that obtained with the negative control protein Bovine serum albumin (BSA). A positive titer after vaccination may be indicative of an immune response to the vaccine.

Anti-Brachyury Antibodies Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	2

Anti-Brachyury Antibodies D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	3

Anti-Brachyury Antibodies D57

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	5

Anti-Brachyury Antibodies D85

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	4

Changes in Serum Cytokines Soluble CD27 (sCD27) and Soluble Factors Secondary · Pre (Baseline), and approximately D29 (Post 1 vaccination), and D85 (post 3 vaccinations)

Serum levels of Soluble CD27 (sCD27) were determined by enzyme-linked immunosorbent assay (ELISA) pre and post vaccination. Changes in levels of serum cytokines and soluble factors was a descriptive result with median and interquartile range reported. No formal statistical analysis by dose level was performed given the small sample size.

sCD27 Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	20.53	1.20 – 51.33
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	19.34	11.24 – 23.57
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	12.10	7.42 – 18.88

sCD27 D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	25.65	16.30 – 47.38
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	18.40	8.02 – 27.10
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	15.12	11.95 – 25.82

sCD27 D85

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	22.35	19.03 – 24.15
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	14.50	9.06 – 25.38
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	16.33	12.10 – 25.99

Changes in Serum Cytokines Soluble CD40 Ligand (sCD40L) and Soluble Factors Secondary · Pre (Baseline), and approximately D29 (Post 1 vaccination), and D85 (post 3 vaccinations)

Serum levels of sCD40L, were determined by enzyme-linked immunosorbent assay (ELISA) pre and post vaccination. Changes in levels of serum cytokines and soluble factors was a descriptive result with median and interquartile range reported. No formal statistical analysis by dose level was performed given the small sample size.

sCD40L Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	4.76	1.55 – 20.34
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	17.52	11.98 – 22.03
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	18.94	14.63 – 26.29

sCD40L D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	17.11	1.00 – 19.79
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	17.81	14.92 – 20.27
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	16.05	11.25 – 19.85

sCD40L D85

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	10.33	1.40 – 18.35
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	17.54	9.77 – 20.32
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	17.90	14.03 – 21.75

Changes in the Ratio of Serums Soluble CD27 (sCD27):Soluble CD40 Ligand (sCD40L) Secondary · Pre (Baseline), and approximately D29 (Post 1 vaccination), and D85 (post 3 vaccinations)

Serum levels of sCD27, sCD40L, and the ratio of sCD27:sCD40L were determined by enzyme-linked immunosorbent assay (ELISA) pre and post vaccination. Changes in levels of serum cytokines and soluble factors was a descriptive result with median and interquartile range reported. No formal statistical analysis by dose level was performed given the small sample size.

sCD27:sCD40L Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	4.31	0.06 – 33.06
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1.02	0.56 – 1.94
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.64	0.35 – 1.28

sCD27:sCD40L D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	1.50	0.82 – 47.38
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1.25	0.42 – 2.06
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.82	0.59 – 2.13

sCD27:sCD40L D85

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	1.84	1.22 – 17.28
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	1.05	0.53 – 2.71
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.89	0.69 – 1.47

Changes in Serum Cytokines Interleukin 2 (IL2), Interleukin 4 (IL4), Interleukin 10 (IL10), and Interferon Gamma (IFNg) Secondary · Pre (Baseline), and approximately D29 (Post 1 vaccination), and D85 (post 3 vaccinations)

Serum levels of IL-2, IL-4, IL-10, and IFNg were determined by enzyme-linked immunosorbent assay (ELISA) pre and post vaccination. Changes in levels of serum cytokines and soluble factors was a descriptive result with median and interquartile range reported. No formal statistical analysis by dose level was performed given the small sample size.

IL-2 Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.00	0.00 – 0.00

IL-2 D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.00	0.00 – 0.00

IL-2 D85

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.00	0.00 – 0.00

IL-10 Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.00	0.00 – 0.00

IL-10 D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.00	0.00 – 0.00

IL-10 D85

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.00	0.00 – 0.00

IL-4 Pre

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.00	0.00 – 0.00

IL-4 D29

Group	Value	95% CI
Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU	0.00	0.00 – 0.00
Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU	0.00	0.00 – 0.00

Adverse events — posted to ClinicalTrials.gov

Time frame: Date treatment consent signed to date off study, approximately 9 months and 6 days for DL1, 17 months and 3 days for DL2, and 23 months and 13 days for DL3.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose Level 1 - 1 Injection - Total Dose 2 x 10^8 IU

Serious: 2/3 (67%)

Deaths: 0/3

Dose Level 2 - 2 Injections - Total Dose 4 x 10^8 IU

Serious: 4/17 (24%)

Deaths: 1/17

Dose Level 3 - 4 Injections - Total Dose 8 x 10^8 IU

Serious: 2/18 (11%)

Deaths: 1/18

Serious adverse events (8 terms)

Reaction	System	Dose Level 1 - 1 Injection…	Dose Level 2 - 2 Injection…	Dose Level 3 - 4 Injection…
Colonic obstruction	Gastrointestinal disorders	—	—	—
Hip fracture	Injury, poisoning and procedural complications	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Colitis	Gastrointestinal disorders	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Lung infection	Infections and infestations	—	—	—
Pain	General disorders	—	—	—
Sepsis	Infections and infestations	—	—	—

Other adverse events (53 terms — click to expand)

Reaction	System	Dose Level 1 - 1 Injection…	Dose Level 2 - 2 Injection…	Dose Level 3 - 4 Injection…
Injection site reaction	General disorders	—	—	—
Flu like symptoms	General disorders	—	—	—
Fever	General disorders	—	—	—
Alkaline phosphatase increased	Investigations	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Platelet count decreased	Investigations	—	—	—
Creatinine increased	Investigations	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Blood bilirubin increased	Investigations	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Fatigue	General disorders	—	—	—
Lymphocyte count decreased	Investigations	—	—	—
Pain	General disorders	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Rash acneiform	Skin and subcutaneous tissue disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—
Blurred vision	Eye disorders	—	—	—
Confusion	Psychiatric disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Edema limbs	General disorders	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—
Hypercalcemia	Metabolism and nutrition disorders	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—
Hypermagnesemia	Metabolism and nutrition disorders	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—
Laryngitis	Infections and infestations	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Non-cardiac chest pain	Musculoskeletal and connective tissue disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Blood and lymphatic system disorders - Other, elevated neutrophil count	Blood and lymphatic system disorders	—	—	—

Most-reported serious reactions: Colonic obstruction, Hip fracture, Abdominal pain, Colitis, Hyponatremia, Lung infection, Pain, Sepsis.

Data from ClinicalTrials.gov NCT02179515 adverse events section.

Sponsor's own description

Background: \- This cancer vaccine was developed to help teach the body's immune system to attack and destroy cancer cells. It teaches immune cells to target the Brachyury protein. This protein is present in some tumor cells, and it can help tumor cells spread to other parts of the body. Researchers want to see whether the new Brachyury protein vaccine can help treat people with advanced carcinomas. Objective: \- To test the safety and effectiveness of giving the modified vaccinia Ankara (MVA)-brachyury-B7-1, ICAM-1 (Intercellular Adhesion Molecule 1), and LFA-3 (lymphocyte function-associated antigen 3) TRICOM vaccine to people with cancer. Eligibility: \- Adults ages 18 and over whose type of cancer has not responded to standard therapies who do not have a history of autoimmune diseases and are capable of taking care of themselves. Design: * Participants will be screened with a medical history and physical exam. They will have blood and urine tests. They may have a computed tomography (CT) scan, a positron emission tomography (PET) scan, and a brain magnetic resonance imaging (MRI) scan. They may have a bone scan. They will have an electrocardiogram (ECG) to test heart rhythm. * Participants will have visits about every 4 weeks. They will have a physical exam and blood and urine tests. They will be injected with the vaccine under the skin into the upper thigh or around the armpits. * CT scans or MRI scans will be done at visit 1, after 3 months on study, and again 3 months later if still on the study. Another ECG will be done at their last vaccine visit. * When participants stop the vaccine, they will return for visits until they recover from any side effects. They will have tests including physical exam, blood tests, scans, and x-rays. * Participants will be asked to enroll in another study for long-term follow-up.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cancer vaccines as promising immuno-therapeutics: platforms and current progress.
Liu J, Fu M, Wang M, Wan D, et al · · 2022 · cited 497× · PMID 35303904 · DOI 10.1186/s13045-022-01247-x
Cancer immunotherapy beyond immune checkpoint inhibitors.
Marin-Acevedo JA, Soyano AE, Dholaria B, Knutson KL, et al · · 2018 · cited 140× · PMID 29329556 · DOI 10.1186/s13045-017-0552-6
Chordoma-Current Understanding and Modern Treatment Paradigms.
Barber SM, Sadrameli SS, Lee JJ, Fridley JS, et al · · 2021 · cited 83× · PMID 33806339 · DOI 10.3390/jcm10051054
The Role of the Tumor Microenvironment and Treatment Strategies in Colorectal Cancer.
Chen Y, Zheng X, Wu C. · · 2021 · cited 77× · PMID 34925375 · DOI 10.3389/fimmu.2021.792691
The Interplay between Circulating Tumor Cells and the Immune System: From Immune Escape to Cancer Immunotherapy.
Leone K, Poggiana C, Zamarchi R. · · 2018 · cited 59× · PMID 30200242 · DOI 10.3390/diagnostics8030059
Phase I Study of a Poxviral TRICOM-Based Vaccine Directed Against the Transcription Factor Brachyury.
Heery CR, Palena C, McMahon S, Donahue RN, et al · · 2017 · cited 55× · PMID 28855356 · DOI 10.1158/1078-0432.ccr-17-1087
Breast Cancer Stem Cells: Signaling Pathways, Cellular Interactions, and Therapeutic Implications.
Wang L, Jin Z, Master RP, Maharjan CK, et al · · 2022 · cited 29× · PMID 35805056 · DOI 10.3390/cancers14133287
Chordoma: The Quest for Better Treatment Options.
Heery CR. · · 2016 · cited 29× · PMID 28261639 · DOI 10.1007/s40487-016-0016-0

Verify or expand the search:

Other recruiting trials for Lung Cancer

Currently open trials in the same condition.

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NCT07146568 — Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hos · NA · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02179515 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 26 January 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02179515.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing