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NCT04434560 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Immunotherapy in Brain Metastases
A Phase 2 study, sponsored by Sarah Sammons, MD.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04434560 is a Phase 2 study that was terminated before completion, run by Sarah Sammons, MD. The registered enrollment target is 1 participants.
The verdict
NCT04434560, a Phase 2 study, was terminated before completion, sponsored by Sarah Sammons, MD.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
The purpose of this phase 2 study is to assess the feasibility and efficacy of neoadjuvant immunotherapy in patients with previously untreated, surgically-resectable, solid tumor brain metastases. The primary objectives of this study are to 1) assess the feasibility of neoadjuvant ipilimumab and nivolumab treatment before surgery and stereotactic radiosurgery (SRS) in patients with solid tumor brain metastases as measured by the proportion of patients who have their surgery delayed or surgery never occurs, and 2) demonstrate that neoadjuvant immunotherapy will increase proliferation of circulating T-cells compared to baseline measurements. Exploratory objectives include describing patient progression free survival and overall survival, time to local and distant intracranial progression, and the rate of radiation necrosis. The rate of radionecrosis will also be explored, as immune expression profiles.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2021-06-17 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04434560
The ClinicalTrials.gov registry entry for NCT04434560 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarah Sammons, MD, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04434560 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04434560 about?
NCT04434560 is a clinical study titled "Neoadjuvant Immunotherapy in Brain Metastases". The purpose of this phase 2 study is to assess the feasibility and efficacy of neoadjuvant immunotherapy in patients with previously untreated, surgically-resectable, solid tumor brain metastases. The primary objectives of this study are to 1) assess the feasibility of neoadjuvant ipilimumab and niv...
What is the current status of trial NCT04434560?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2020-11-04. Estimated completion is 2021-06-17.
What interventions are being tested in trial NCT04434560?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT04434560?
This trial is sponsored by Sarah Sammons, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
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