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

July 21, 2020 updated by: Gary Onik MD

A Retrospective and Prospective Study of a New Immunotherapy Regimen (MyVaccx) for Patients With Adenocarcinoma.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

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

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33301
        • The Center for High Risk and Recurrent Prostate Cancer

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.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with adenocarcinoma treated with the MyVaccx System through the Center for High Risk and Recurrent Prostate Cancer.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 2 subjects treated with the MyVaccx System with known visceral disease

Study Plan

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

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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
Other Names:
  • Yervoy, Keytruda, Leukine
Device: Ablation
Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents
Other Names:
  • Cryo and radio frequency (RF) ablation

What is the study measuring?

Primary Outcome Measures

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

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

Collaborators and Investigators

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

Sponsor

Gary Onik MD

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 Major Dates

Study Start (Actual)

April 11, 2018

Primary Completion (Actual)

July 8, 2019

Study Completion (Actual)

June 17, 2020

Study Registration Dates

First Submitted

September 28, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIRPA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Results will be published in a medical journal.

IPD Sharing Time Frame

After retrospective data collection is completed.

IPD Sharing Supporting Information Type

  • Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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