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NCT04420975 · ClinicalTrials.gov registry record · Phase 1
Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma
A Phase 1 study of Leiomyosarcoma and Myxofibrosarcoma, sponsored by Jonsson Comprehensive Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT04420975: Active Phase 1 study of Leiomyosarcoma and Myxofibrosarcoma, sponsored by Jonsson Comprehensive Cancer Center.
NCT04420975 is a Phase 1 study of Leiomyosarcoma and Myxofibrosarcoma that is active but no longer recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 14 participants, below the 121-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04420975, a Phase 1 study of Leiomyosarcoma and Myxofibrosarcoma, is active but no longer recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies the side effects of BO-112 when given together with nivolumab before surgery in treating patients with soft tissue sarcoma that can be removed by surgery (resectable). 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. Immunotherapy with BO-112, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab and BO-112 before surgery may work better in treating patients with soft tissue sarcoma compared to nivolumab alone.
Primary Outcome
AEs will be tabulated by type, severity, and the proportion of subject experiencing the event.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- BIOLOGICAL Nivolumab
- PROCEDURE Definitive Surgical Resection
- BIOLOGICAL Nanoplexed Poly I:C BO-112
Study Locations (1)
California
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2020-10-14 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 1 |
What the registry record for NCT04420975 still lists
NCT04420975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 121-participant average among 16 other Leiomyosarcoma trials with a reported enrollment target (88% lower).
The record links to 10 conditions, with Leiomyosarcoma appearing as the primary indexed condition, and to 4 interventions - of which Radiation Therapy is the first listed.
NCT04420975 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04420975 about?
NCT04420975 is a clinical study titled "Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma". This phase I trial studies the side effects of BO-112 when given together with nivolumab before surgery in treating patients with soft tissue sarcoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the...
What is the current status of trial NCT04420975?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2020-10-14. Estimated completion is 2028-01-31.
What conditions does trial NCT04420975 study?
This clinical trial studies the following conditions: Leiomyosarcoma, Myxofibrosarcoma, Malignant Peripheral Nerve Sheath Tumor, Resectable Soft Tissue Sarcoma, Pleomorphic Rhabdomyosarcoma.
What interventions are being tested in trial NCT04420975?
The interventions under investigation include: Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Definitive Surgical Resection (PROCEDURE), Nanoplexed Poly I:C BO-112 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04420975?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04420975 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04420975's enrollment target sits among peer trials
14 17th of 16 the lowest of 16 other Leiomyosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Leiomyosarcoma 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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