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NCT03655002 · ClinicalTrials.gov registry record · Phase 1
IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer
A Phase 1 study of Stage IV Hepatocellular Carcinoma AJCC v8 and Stage IVA Hepatocellular Carcinoma AJCC V8, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 3
- Study locations
NCT03655002: Active Phase 1 study of Stage IV Hepatocellular Carcinoma AJCC v8 and Stage IVA Hepatocellular Carcinoma AJCC V8, sponsored by City of Hope Medical Center.
NCT03655002 is a Phase 1 study of Stage IV Hepatocellular Carcinoma AJCC v8 and Stage IVA Hepatocellular Carcinoma AJCC V8 that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 8 participants, below the 60-participant average among 14 other Stage IV Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (87% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03655002, a Phase 1 study of Stage IV Hepatocellular Carcinoma AJCC v8 and Stage IVA Hepatocellular Carcinoma AJCC V8, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase Ib trial studies the side effects and best dose of IRX-2 when given together with cyclophosphamide and nivolumab in treating patients with liver cancer that has come back or spread to other parts of the body and does not response to treatment. Biological therapies, such as IRX-2, may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving IRX-2, cyclophosphamide, and nivolumab may work better than the IRX?2 regimen alone in treating patients with hepatocellular carcinoma.
Primary Outcome
This is based on Simon?s MiniMax design.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL Nivolumab
- BIOLOGICAL Cytokine-based Biologic Agent IRX-2
Study Locations (3)
Arizona
- HonorHealth Research Institute - Scottsdale
California
- City of Hope Medical Center - Duarte
Texas
- Texas Oncology at Baylor Charles A Sammons Cancer Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-02-21 |
| Est. Completion | 2026-03-30 |
| Phase | Phase 1 |
What the registry record for NCT03655002 still lists
NCT03655002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 14 other Stage IV Hepatocellular Carcinoma AJCC v8 trials with a reported enrollment target (87% lower).
The record links to 5 conditions, with Stage IV Hepatocellular Carcinoma AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT03655002 reports a single indexed study location in Arizona, California, Texas.
Frequently Asked Questions
What is clinical trial NCT03655002 about?
NCT03655002 is a clinical study titled "IRX-2, Cyclophosphamide, and Nivolumab in Treating Patients With Recurrent or Metastatic and Refractory Liver Cancer". This phase Ib trial studies the side effects and best dose of IRX-2 when given together with cyclophosphamide and nivolumab in treating patients with liver cancer that has come back or spread to other parts of the body and does not response to treatment. Biological therapies, such as IRX-2, may stim...
What is the current status of trial NCT03655002?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2019-02-21. Estimated completion is 2026-03-30.
What conditions does trial NCT03655002 study?
This clinical trial studies the following conditions: Stage IV Hepatocellular Carcinoma AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC V8, Stage IVB Hepatocellular Carcinoma AJCC V8, Recurrent Hepatocellular Carcinoma, Refractory Liver Carcinoma.
What interventions are being tested in trial NCT03655002?
The interventions under investigation include: Cyclophosphamide (DRUG), Nivolumab (BIOLOGICAL), Cytokine-based Biologic Agent IRX-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03655002?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03655002 being conducted?
This trial has 3 study locations across Arizona, California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03655002's enrollment target sits among peer trials
8 15th of 14 the lowest of 14 other Stage IV Hepatocellular Carcinoma AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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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