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NCT04116320 · ClinicalTrials.gov registry record · Phase 1
Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors
A Phase 1 study, sponsored by Craig L Slingluff, Jr.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT04116320 is a Phase 1 study that was terminated before completion, run by Craig L Slingluff, Jr. The registered enrollment target is 5 participants.
The verdict
NCT04116320, a Phase 1 study, was terminated before completion, sponsored by Craig L Slingluff, Jr.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This study evaluates whether it is safe to Focused Ultrasound Ablation (FUSA) treatments with and without PD-1 blockade and with and without intratumoral poly-ICLC. A device called the Echopulse will be used for the FUSA therapy. Patients will be assigned to 1 of 2 cohorts depending on their disease and treatment status. In Cohort 1, patients will receive FUSA therapy while receiving PD-1 blockade therapy as part of standard clinical care treatment. In Cohort 2, patients who discontinue or are ineligible for PD-1 blockade therapy will undergo FUSA without concurrent systemic therapy, with the goal of utilizing the FUSA to boost the innate immune response. The optional secondary regimen will combine FUSA (+/- PD-1 blockade) with intratumoral poly-ICLC.
Interventions
- DRUG Poly ICLC
- DEVICE Echopulse
- DRUG Standard of Care PD-1 Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-11-21 |
| Est. Completion | 2023-08-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04116320
The ClinicalTrials.gov registry entry for NCT04116320 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Craig L Slingluff, Jr, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Poly ICLC is the first listed.
NCT04116320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04116320 about?
NCT04116320 is a clinical study titled "Focused Ultrasound Ablation and PD-1 Antibody Blockade in Advanced Solid Tumors". This study evaluates whether it is safe to Focused Ultrasound Ablation (FUSA) treatments with and without PD-1 blockade and with and without intratumoral poly-ICLC. A device called the Echopulse will be used for the FUSA therapy. Patients will be assigned to 1 of 2 cohorts depending on their disease...
What is the current status of trial NCT04116320?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2019-11-21. Estimated completion is 2023-08-15.
What interventions are being tested in trial NCT04116320?
The interventions under investigation include: Poly ICLC (DRUG), Echopulse (DEVICE), Standard of Care PD-1 Therapy (DRUG).
Who is sponsoring clinical trial NCT04116320?
This trial is sponsored by Craig L Slingluff, Jr, which has 23 total clinical trials registered on ClinicalTrials.gov.
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