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

NCT03695835 | Completed FDA Drug FDA Device

• 1 other identifier: NIRPA
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenocarcinoma

Keywords

prostate cancer; lung cancer; pancreatic cancer; colorectal cancer; bladder cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• MyVaccx immunotherapy treatment impact on late stage cancer disease

  Time to progression after a complete or partial response up to 60 months

Study Arms (1)

Adenocarcinoma treated with MyVaccx

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

Drug: Immunotherapeutic Agents; Device: Ablation

Interventions

Immunotherapeutic Agents DRUG

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

Also known as: Yervoy, Keytruda, Leukine

Adenocarcinoma treated with MyVaccx

Ablation DEVICE

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

Also known as: Cryo and radio frequency (RF) ablation

Adenocarcinoma treated with MyVaccx

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• subjects treated with the MyVaccx System with known visceral disease

Sponsors & Collaborators

• Gary Onik MD: lead

Study Sites (1)

The Center for High Risk and Recurrent Prostate Cancer

Fort Lauderdale, Florida, 33301, United States

Location

MeSH Terms

Conditions

Adenocarcinoma; Prostatic Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms; Urinary Bladder Neoplasms

Interventions

Ipilimumab; pembrolizumab; sargramostim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 4, 2018
• Study Start: April 11, 2018
• Primary Completion: July 8, 2019
• Study Completion: June 17, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After retrospective data collection is completed.

Locations

US (1)