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

Adenocarcinoma Clinical Trial

— NIRPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695835
• Other study ID #: NIRPA
• Status: Completed
• Start date: April 11, 2018
• Est. completion date: June 17, 2020

Study information

• Verified date: July 2020
• Source: Gary Onik MD
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 17, 2020
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma

Intervention

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

Locations

Country	Name	City	State
United States	The Center for High Risk and Recurrent Prostate Cancer	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gary Onik MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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