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IL-12 Gene and in Vivo Electroporation-Mediated Plasmid DNA Vaccine Therapy in Patients With Merkel Cell Cancer (MCC)

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ClinicalTrials.gov Identifier: NCT01440816
Recruitment Status : Completed
First Posted : September 27, 2011
Results First Posted : December 12, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OncoSec Medical Incorporated

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Merkel Cell Carcinoma
Interventions: Biological: Tavokinogene Telseplasmid (tavo)
Device: OncoSec Medical System (OMS)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 1 investigative site in the United States from 03 January 2012 to 10 April 2015.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort A: Tavo-EP Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
Cohort B: Tavo-EP Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.

Participant Flow:   Overall Study
    Cohort A: Tavo-EP   Cohort B: Tavo-EP
STARTED   3   12 
COMPLETED   2   1 
NOT COMPLETED   1   11 
Disease Progression                0                9 
To Be Seen By Local Oncologist                1                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set, all patients who received any amount of the study drug (tavo).

Reporting Groups
  Description
Cohort A: Tavo-EP Patients in Cohort A received one cycle (3 daily treatments on Days 1, 5, and 8) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, after which they proceeded to definitive treatment (surgery and/or radiation therapy) which started between 2 and 4 weeks after the first injection.
Cohort B: Tavo-EP Patients in Cohort B received up to 4 cycles (3 daily treatments on Days 1, 5, and 8, per cycle) of intra-tumoral injection(s) of tavo at a fixed dose of 0.5 mg/mL (up to 4 tumor sites) followed immediately by in vivo electroporation, with 12 weeks planned between each cycle, lasting up to 12 months.
Total Total of all reporting groups

Baseline Measures
   Cohort A: Tavo-EP   Cohort B: Tavo-EP   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   12   15 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.7  (11.59)   68.7  (12.08)   67.1  (12.03) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      3  25.0%      3  20.0% 
Male      3 100.0%      9  75.0%      12  80.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   3   12   15 


  Outcome Measures

1.  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   [ Time Frame: Pre-treatment up to Week 13 ]

2.  Secondary:   Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: From signing of informed consent to 8 weeks after the last dose of study treatment (up to 15 months) ]

3.  Secondary:   Objective Response Rate (ORR) in Injected and Non-injected (Distant) Lesions   [ Time Frame: 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) ]

4.  Secondary:   Time to Progression (TTP)   [ Time Frame: 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) ]

5.  Secondary:   Overall Survival   [ Time Frame: From the start of study treatment until death (up to 15 months) ]

6.  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   [ Time Frame: Pre-treatment up to Week 13 ]

7.  Secondary:   Local Regression Rate   [ Time Frame: 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) ]

8.  Secondary:   Distant Regression Rate   [ Time Frame: 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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sharron E Gargosky, Chief Clinical Regulatory Officer
Organization: OncoSec Medical Incorporated
phone: +1 858-255-4729
e-mail: ClinicalTrialsInfo@OncoSec.com



Responsible Party: OncoSec Medical Incorporated
ClinicalTrials.gov Identifier: NCT01440816     History of Changes
Other Study ID Numbers: OMS-I110
NCI-2011-01221 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 2011
First Posted: September 27, 2011
Results First Submitted: November 14, 2017
Results First Posted: December 12, 2017
Last Update Posted: January 18, 2018