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

Completed

• Conditions: Adenocarcinoma
• Interventions: Drug: Immunotherapeutic Agents; Device: Ablation

• Registration Number: NCT03695835
• Lead Sponsor: Gary Onik MD

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-11
• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Primary Completion: 2019-07-08
• Study Completion: 2020-06-17
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adenocarcinoma treated with MyVaccx	Immunotherapeutic Agents	MyVaccx combines tumor ablation and immunotherapeutic agents for treatment of late stage cancer disease..
Adenocarcinoma treated with MyVaccx	Ablation	MyVaccx combines tumor ablation and immunotherapeutic agents for treatment of late stage cancer disease..

Primary Outcome Measures

Name	Time	Method
MyVaccx immunotherapy treatment impact on late stage cancer disease	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 Outcome Measures

Name	Time	Method
MyVaccx immunotherapy treatment impact on late stage cancer disease	Time to progression after a complete or partial response up to 60 months	Complete and partial response to treatment based on the iRESIST criteria

Trial Locations

Locations (1)

The Center for High Risk and Recurrent Prostate Cancer; 🇺🇸 Fort Lauderdale, Florida, United States