AdenocarcinomaNIRPANCT03695835
A Data Collection Study for Patients With Adenocarcinoma Treated With the MyVaccx Immunotherapy Regimen.
An observational study of Adenocarcinoma, run by Gary Onik MD at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adenocarcinoma
- What is being tested?
- Immunotherapeutic Agents and Ablation
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 17 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with adenocarcinoma treated with the MyVaccx System through the Center for High Risk and Recurrent Prostate Cancer.
Who may be able to join
- Treatment with the MyVaccx System
- Greater than 18 years of age
- Signature of the informed consent
Who cannot join
- 2 subjects treated with the MyVaccx System with known visceral disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for High Risk and Recurrent Prostate Cancer
Fort Lauderdale, Florida, 33301
About this study
Official title: 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.
- Conditions
- Adenocarcinoma
- Being tested
- Immunotherapeutic Agents, Ablation
- Keywords
- prostate cancer, lung cancer, pancreatic cancer, colorectal cancer, bladder cancer
- Medical subject headings
- Adenocarcinoma, Prostatic Neoplasms, Lung Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapeutic AgentsDrug
Also called Yervoy, Keytruda, Leukine
Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents
AblationDevice
Also called Cryo and radio frequency (RF) ablation
Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents
| Study group | Role | What they receive |
|---|---|---|
| Adenocarcinoma treated with MyVaccx | MyVaccx combines tumor ablation and immunotherapeutic agents for treatment of late stage cancer disease.. Receives: Drug: Immunotherapeutic Agents; Device: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
MyVaccx immunotherapy treatment impact on late stage cancer disease
Time to death after the start of treatment
Measured: 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
Complete and partial response to treatment based on the iRESIST criteria
Measured: Time to progression after a complete or partial response up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start11 Apr 2018
- Primary completion8 Jul 2019
- Study completion17 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gary Onik MD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695835
- Sponsor's protocol ID
- NIRPA
- Acronym
- NIRPA
- Status last verified
- Jul 2020
- First submitted
- 28 Sep 2018
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Results will be published in a medical journal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective and Prospective Study of a New Immunotherapy Regimen (MyVaccx) for Patients With Adenocarcinoma.
- ClinicalTrials.gov ID
- NCT03695835
- Acronym / sponsor ID
- NIRPA / NIRPA
- Conditions
- Adenocarcinoma
- Keywords
- prostate cancer, lung cancer, pancreatic cancer, colorectal cancer, bladder cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Gary Onik MD
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 8 Jul 2019 (actual)
- Study completion
- 17 Jun 2020 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adenocarcinoma treated with MyVaccx | – | Drug: Immunotherapeutic Agents, Device: AblationMyVaccx combines tumor ablation and immunotherapeutic agents for treatment of late stage cancer disease.. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with adenocarcinoma treated with the MyVaccx System through the Center for High Risk and Recurrent Prostate Cancer.
Key inclusion criteria (3 listed)
- Treatment with the MyVaccx System
- Greater than 18 years of age
- Signature of the informed consent
Key exclusion criteria (1 listed)
- 2 subjects treated with the MyVaccx System with known visceral disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunotherapeutic AgentsAlso: Yervoy, Keytruda, LeukineAntigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents | Drug | Adenocarcinoma treated with MyVaccx |
| AblationAlso: Cryo and radio frequency (RF) ablationAntigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents | Device | Adenocarcinoma treated with MyVaccx |
Primary outcome
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
1 secondary outcome
MyVaccx immunotherapy treatment impact on late stage cancer disease
Time frame: Time to progression after a complete or partial response up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: Yes. Results will be published in a medical journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenocarcinoma, run by Gary Onik MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.