A Data Collection Study For Patients With Adenocarcinoma Treated With The MyVaccx Immunotherapy Regimen.

Study Overview

A Data Collection Study for Patients With Adenocarcinoma Treated With the MyVaccx Immunotherapy Regimen.

A retrospective and prospective data collection study on 27 consecutive subjects with adenocarcinoma who were treated using the MyVaccx system by Dr. Gary Onik. Retrospective data were collected on the treatment with the immunotherapy system and prospective data will be collected as they are prospectively monitored through their normal standard of care for their original cancer.

N/A

Adenocarcinoma

DRUG: Immunotherapeutic Agents
DEVICE: Ablation

NIRPA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-09-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-07-21
First Submitted that Met QC Criteria 2018-10-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-07-22
First Posted (ACTUAL) 2018-10-04	Results First Posted N/A	Last Verified 2020-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Adenocarcinoma treated with MyVaccx MyVaccx combines tumor ablation and immunotherapeutic agents for treatment of late stage cancer disease..	DRUG: Immunotherapeutic Agents Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents DEVICE: Ablation Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents

Participant Group/Arm

Intervention/Treatment

: Adenocarcinoma treated with MyVaccx

MyVaccx combines tumor ablation and immunotherapeutic agents for treatment of late stage cancer disease..

DRUG: Immunotherapeutic Agents

Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents

DEVICE: Ablation

Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents

Primary Outcome Measures	Measure Description	Time Frame
MyVaccx immunotherapy treatment impact on late stage cancer disease	Time to death after the start of treatment	From date of treatment until the date of death from any cause up to 60 months

Secondary Outcome Measures	Measure Description	Time Frame
MyVaccx immunotherapy treatment impact on late stage cancer disease	Complete and partial response to treatment based on the iRESIST criteria	Time to progression after a complete or partial response up to 60 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
19 Years

Accepts Healthy Volunteers:

Treatment with the MyVaccx System
Greater than 18 years of age
Signature of the informed consent

2 subjects treated with the MyVaccx System with known visceral disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Resources

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Clinical Trial Record