Trial · NCT01440816
IL-12 Gene and in Vivo Electroporation-Mediated Plasmid DNA Vaccine Therapy in Patients With Merkel Cell Cancer
NCT01440816, Phase 2, Completed, OncoSec Medical Incorporated; results first posted 2017-12-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. IL-12 Gene and in Vivo Electroporation-Mediated Plasmid DNA Vaccine Therapy in Patients With Merkel Cell Cancer. Trials, record NCT01440816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01440816
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IL-12 Gene and in Vivo Electroporation-Mediated Plasmid DNA Vaccine Therapy in Patients With Merkel Cell Cancer
- NCT number
- NCT01440816
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- OncoSec Medical Incorporated
- Conditions
- Merkel Cell Carcinoma
- Interventions
- Tavokinogene Telseplasmid (tavo), OncoSec Medical System (OMS)
- First posted
- 2011-09-27
- Last updated
- 2023-05-15
- Results first posted
- 2017-12-12
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced At Least 2-Fold Increase in Expression of IL-12 Protein in the Tumor Tissue After Intratumoral (IT) pIL-12 Injections and In Vivo Electroporation | Pre-treatment up to Week 13 | The MAGPIX assay was used to assess differential expression of hIL-12 in patient tumor tissue before and after treatment with intratumoral (IT) tavo injections and in vivo electroporation (EP). Expression of hIL-12 was used to identify patients who met the primary endpoint of a 2-fold or higher increase in expression of hIL-12 in tumors after treatment. Fold change was taken as a comparison of hIL-12 expression at Week 3:pre-treatment, Week 6:pre-treatment, Week 8:pre-treatment, or Week 13:pre-treatment over baseline (pre- treatment). The fold change was calculated as log2 (time point/baseline). |
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From signing of informed consent to 8 weeks after the last dose of study treatment (up to 15 months) | An AE was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, medical treatment or procedure and which did not necessarily have to have had a causal relationship with this treatment. An adverse event could have, therefore, been any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, medical treatment or procedure whether or not considered related to the medicinal product. An SAE was defined an any untoward medical occurrence that at any dosage resulted in one or more of the following: death, A life-threatening adverse event (real risk of dying), inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, required intervention to prevent permanent impairment of damage. |
| Secondary | Objective Response Rate (ORR) in Injected and Non-injected (Distant) Lesions | 3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months) | ORR is defined as the percentage of participants with evaluable lesions that achieved a complete response (CR) or partial response (PR) as assessed by the investigator using Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: Disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions. The same method was used to assess response rate for treated lesions and response rate for non-treated lesions. The best response rate for non-treated lesions was based on the number of patients who had at least one non-treated lesion. |
| Secondary | Time to Progression (TTP) | 3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months) | TTP is defined as the number of days between the treatment initiation date (Study Day 1) and the earliest date of documented disease progression as defined by RECIST 1.1 or death that is not associated with prior disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. |
| Secondary | Overall Survival | From the start of study treatment until death (up to 15 months) | Overall survival is defined as the time in days from the date of first study drug administration to the date of death. |
| Secondary | Immunologic Effects of IT pIL-12 Injection and In Vivo EP Measured By: Percentage of Participants With a Positive Fold Change (Log2) in IL-12A Messenger Ribonucleic Acid (mRNA) for Patient Pre- and Post IT pIL 12 EP | Pre-treatment up to Week 13 | Nanostring analysis was performed to determine the expression (mRNA) of IL-12. For each study patient, the fold change (log2 transformed) in IL-12A mRNA as measured by Nanostring was determined using the pre-treatment (screening) biopsy as a reference for the post treatment biopsy. A log2 fold change \>=1 is a positive result. |
| Secondary | Local Regression Rate | 3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months) | Local regression rate is defined as the percentage of participants with ≥30% regression (decrease in size) of at least one assessed local (injected) lesion. |
| Secondary | Distant Regression Rate | 3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months) | Distant regression rate is defined as the percentage of participants with ≥30% regression (decrease in size) of at least one assessed distant (non-injected) lesion. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Experienced At Least 2-Fold Increase in Expression of IL-12 Protein in the Tumor Tissue After Intratumoral (IT) pIL-12 Injections and In Vivo Electroporation | Pre-treatment up to Week 13 | Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From signing of informed consent to 8 weeks after the last dose of study treatment (up to 15 months) | Safety Analysis Set, all patients who received any amount of the study drug (tavo). | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) in Injected and Non-injected (Distant) Lesions | 3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months) | Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo) and had evaluable lesions. | percentage of participants | NUMBER |
| SECONDARY | Time to Progression (TTP) | 3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months) | Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo) and had document disease progression. | days | MEDIAN |
| SECONDARY | Overall Survival | From the start of study treatment until death (up to 15 months) | Efficacy Analysis Set, all patients who received any amount of the study drug (tavo). Zero participants were analyzed for overall survival because all patients were alive at their study completion visit. | ||
| SECONDARY | Immunologic Effects of IT pIL-12 Injection and In Vivo EP Measured By: Percentage of Participants With a Positive Fold Change (Log2) in IL-12A Messenger Ribonucleic Acid (mRNA) for Patient Pre- and Post IT pIL 12 EP | Pre-treatment up to Week 13 | Efficacy Analysis Set, all patients from Cohort B who received any amount of the study drug (tavo) and had evaluable lesions. | percentage of participants | NUMBER |
| SECONDARY | Local Regression Rate | 3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months) | All patients from Cohorts A and B with evaluable lesions. | percentage of participants | NUMBER |
| SECONDARY | Distant Regression Rate | 3-4 weeks after the first dose in each cycle and then every 3 months until disease progression, death or withdrawal of consent (up to 15 months) | All patients from Cohorts A and B with evaluable lesions. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Experienced At Least 2-Fold Increase in Expression of IL-12 Protein in the Tumor Tissue After Intratumoral (IT) pIL-12 Injections and In Vivo Electroporation | Cohort B: Tavo-EP | 83 | percentage of participants | ||
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Cohort A: Tavo-EP | AEs | 100 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Cohort B: Tavo-EP | AEs | 100 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Cohort A: Tavo-EP | SAEs | 0 | percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Cohort B: Tavo-EP | SAEs | 8.3 | percentage of participants | |
| Objective Response Rate (ORR) in Injected and Non-injected (Distant) Lesions | Cohort B: Tavo-EP | Injected Lesions | 33.3 | percentage of participants | |
| Objective Response Rate (ORR) in Injected and Non-injected (Distant) Lesions | Cohort B: Tavo-EP | Non-Injected Lesions | 20.0 | percentage of participants | |
| Time to Progression (TTP) | Cohort B: Tavo-EP | 52.5 | 95% Confidence Interval 42.0 to 84.0 | days | |
Immunologic Effects of IT pIL-12 Injection and In Vivo EP Measured By: Percentage of Participants With a Positive Fold Change (Log2) in IL-12A Messenger Ribonucleic Acid (mRNA) for Patient Pre- and Post IT pIL 12 EP | Cohort B: Tavo-EP | 66.6 | percentage of participants | ||
| Local Regression Rate | All Patients: Tavo-EP | 45.5 | percentage of participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A: Tavo-EP | 3 | |
| Overall Study | STARTED | Cohort B: Tavo-EP | 12 | |
| Overall Study | COMPLETED | Cohort A: Tavo-EP | 2 | |
| Overall Study | COMPLETED | Cohort B: Tavo-EP | 1 | |
| Overall Study | NOT COMPLETED | Cohort A: Tavo-EP | 1 | |
| Overall Study | NOT COMPLETED | Cohort B: Tavo-EP | 11 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Procedural pain | Injury, poisoning and procedural complications | Cohort A: Tavo-EP | 3 | 3 | |
| other | Procedural pain | Injury, poisoning and procedural complications | Cohort B: Tavo-EP | 12 | 12 | |
| other | Contusion | Injury, poisoning and procedural complications | Cohort A: Tavo-EP | 0 | 3 | |
| other | Contusion | Injury, poisoning and procedural complications | Cohort B: Tavo-EP | 1 | 12 | |
| other | Seroma | Injury, poisoning and procedural complications | Cohort A: Tavo-EP | 1 | 3 | |
| other | Seroma | Injury, poisoning and procedural complications | Cohort B: Tavo-EP | 0 | 12 | |
| other | Injection site inflammation | General disorders | Cohort A: Tavo-EP | 2 | 3 | |
| other | Injection site inflammation | General disorders | Cohort B: Tavo-EP | 6 | 12 | |
| other | Injection site discolouration | General disorders | Cohort A: Tavo-EP | 1 | 3 | |
| other | Injection site discolouration | General disorders | Cohort B: Tavo-EP | 4 | 12 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A: Tavo-EP | ||
| Total, all-cause mortality | Cohort B: Tavo-EP | ||
| Total, other adverse events | Cohort A: Tavo-EP | 3 | 3 |
| Total, other adverse events | Cohort B: Tavo-EP | 12 | 12 |
| Total, serious adverse events | Cohort A: Tavo-EP | 0 | 3 |
| Total, serious adverse events | Cohort B: Tavo-EP | 1 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Cohort A: Tavo-EP vs Cohort B: Tavo-EP: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01440816
GET https://conductscience.org/api/trials/v1/NCT01440816/events?page=2