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Completed

NCT Number: NCT03695835

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.

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Key information

Conditions

Adenocarcinoma Carcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Center for High Risk and Recurrent Prostate Cancer

Fort Lauderdale, Florida, 33301, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunotherapeutic Agents

Drug

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

Other names: Yervoy, Keytruda, Leukine

ablation

Device

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

Other names: Cryo and radio frequency (RF) ablation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Gary Onik MD

Indiv

Registry information

Official study title

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

Acronym: NIRPA

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 4, 2018
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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