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NCT03942328 · ClinicalTrials.gov registry record · Phase 1
Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer
A Phase 1 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
- 1
- Study location
NCT03942328: Recruiting Phase 1 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, sponsored by Mayo Clinic.
NCT03942328 is a Phase 1 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 85 participants, above the 54-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (57% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03942328, a Phase 1 study of Stage III Hepatocellular Carcinoma AJCC v8 and Stage IV Hepatocellular Carcinoma AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
- 1
- Study location
Study Summary
This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in combination with immune checkpoint inhibition (with bevacizumab and atezolizumab or druvalumab) in treating patients liver cancer that cannot be removed by surgery (unresectable) after undergoing standard high-dose external beam radiotherapy. Autologous dendritic cells are immune cells generated from patients' own white blood cells that are grown in a special lab and trained to stimulate the immune system to destroy tumor cells. A pneumonia vaccine called Prevnar may also help stimulate the immune system. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Immunotherapy with monoclonal antibodies, such as atezolizumab and durvalumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving autologous dendritic cells and Prevnar in combination with immune checkpoint inhibition after radiotherapy may be safe, and tolerable and may stimulate the body's own immune system to fight against the tumor in patients with unresectable liver cancer.
Primary Outcome
A significant toxicity is defined as a dose limiting toxicity that is possibly, probably, or definitely related to dendritic cell (DC) treatment. Toxicities will be assessed using the Cancer Therapy Evaluation Program active version of the Common Terminology Criteria for Adverse Events.
Conditions Studied
Interventions
- BIOLOGICAL Atezolizumab
- RADIATION External Beam Radiation Therapy
- BIOLOGICAL Bevacizumab
- PROCEDURE Pheresis
- BIOLOGICAL Pneumococcal 13-valent Conjugate Vaccine
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2019-09-19 |
| Est. Completion | 2028-02-29 |
| Phase | Phase 1 |
What NCT03942328 shows while recruiting
NCT03942328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 54-participant average among 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (57% higher).
The record links to 6 conditions, with Stage III Hepatocellular Carcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Atezolizumab is the first listed.
NCT03942328 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03942328 about?
NCT03942328 is a clinical study titled "Modified Immune Cells (Autologous Dendritic Cells) and a Vaccine (Prevnar) Combined With Immune Checkpoint Inhibition After High-Dose External Beam Radiation Therapy in Treating Patients With Unresectable Liver Cancer". This early phase I trial studies the side effects of autologous dendritic cells and a vaccine called Prevnar in combination with immune checkpoint inhibition (with bevacizumab and atezolizumab or druvalumab) in treating patients liver cancer that cannot be removed by surgery (unresectable) after und...
What is the current status of trial NCT03942328?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2019-09-19. Estimated completion is 2028-02-29.
What conditions does trial NCT03942328 study?
This clinical trial studies the following conditions: Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Unresectable Hepatocellular Carcinoma, Stage III Intrahepatic Cholangiocarcinoma AJCC v8, Stage IV Intrahepatic Cholangiocarcinoma AJCC v8.
What interventions are being tested in trial NCT03942328?
The interventions under investigation include: Atezolizumab (BIOLOGICAL), External Beam Radiation Therapy (RADIATION), Bevacizumab (BIOLOGICAL), Pheresis (PROCEDURE), Pneumococcal 13-valent Conjugate Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03942328?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03942328 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Hepatocellular Carcinoma AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03942328's enrollment target sits among peer trials
85 4th of 14 higher than 11 of 14 other Stage III Hepatocellular Carcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Hepatocellular Carcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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