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NCT03758781 · ClinicalTrials.gov registry record · Phase 1
IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT03758781: Completed Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03758781 is a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 12 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03758781, a Phase 1 study of Non-Small Cell Lung Cancer and Solid Tumor, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors. Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone.
Primary Outcome
A DLT is defined as any Grade 3 or higher toxicity which occurs during the DLT evaluation period of 4 weeks (during Cycle 1 Day 1 and Cycle 1 Day 28) and considered related to study treatment. Toxicity that is clearly and directly related to the primary disease or to another etiology is excluded.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG IRX 2
Study Locations (1)
Florida
- H Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-02-13 |
| Est. Completion | 2021-08-11 |
| Phase | Phase 1 |
What the finished NCT03758781 record still lists
NCT03758781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (98% lower).
The record links to 9 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.
NCT03758781 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03758781 about?
NCT03758781 is a clinical study titled "IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors". This study is to determine the safety of IRX-2 Regimen combined with Nivolumab in patients with recurrent metastatic solid tumors. Researchers believe that this combination will have a tolerable safety profile and will increase the response rate in comparison to Nivolumab alone.
What is the current status of trial NCT03758781?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-02-13. Estimated completion is 2021-08-11.
What conditions does trial NCT03758781 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Solid Tumor, Renal Cell Carcinoma, Metastatic Cancer, Urothelial Carcinoma.
What interventions are being tested in trial NCT03758781?
The interventions under investigation include: Nivolumab (DRUG), IRX 2 (DRUG).
Who is sponsoring clinical trial NCT03758781?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03758781 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03758781's enrollment target sits among peer trials
12 437th of 454 higher than 12 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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