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NCT04572451 · ClinicalTrials.gov registry record · Phase 1
Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma
A Phase 1 study of Melanoma and Neoplasms, sponsored by Yana Najjar.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT04572451: Recruiting Phase 1 study of Melanoma and Neoplasms, sponsored by Yana Najjar.
NCT04572451 is a Phase 1 study of Melanoma and Neoplasms that is actively recruiting participants, run by Yana Najjar. The registered enrollment target is 50 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (93% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04572451, a Phase 1 study of Melanoma and Neoplasms, is actively recruiting participants, sponsored by Yana Najjar.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
Nivolumab (and other agents affecting the anti-programmed death-1 \[anti-PD-1\] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy and overcome resistance. In this phase I/Ib study, radiation will be used in combination with IO agents nivolumab and anti-IL-8 (BMS-986253) to assess toxicity by organ system and then assess the preliminary efficacy of the treatment regimen. In Part 1, the study will determine the safe doses of radiation by organ site in conjunction with nivolumab and BMS-986253. In Part 2, the treatment regimen will be investigated in melanoma, prioritizing acral melanoma, to describe the response rate to treatment as well as other clinical and safety outcomes. The study will also provide the opportunity to evaluate changes in the tumor microenvironment induced by the treatment.
Primary Outcome
The rate of Dose Limiting Toxicities (DLT) that are determined to be definitely, probably or possibly attributed to SBRT or one or both of the immunotherapies. Patients receiving one of more fractions of SBRT are evaluable for DLT. Toxicities include grade 3 or higher adverse events, by organ system, by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Conditions Studied
Interventions
- DRUG nivolumab
- DRUG BMS-986253
- RADIATION Stereotactic Body Radiotherapy (SBRT)
Study Locations (2)
Illinois
- University of Chicago Medical Center - Chicago
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-11-29 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 1 |
What NCT04572451 shows while recruiting
NCT04572451 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (93% lower).
The record links to 10 conditions, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which nivolumab is the first listed.
NCT04572451 reports a single indexed study location in Illinois, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04572451 about?
NCT04572451 is a clinical study titled "Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma". Nivolumab (and other agents affecting the anti-programmed death-1 \[anti-PD-1\] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response ra...
What is the current status of trial NCT04572451?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2021-11-29. Estimated completion is 2027-05-31.
What conditions does trial NCT04572451 study?
This clinical trial studies the following conditions: Melanoma, Neoplasms, Neoplasms by Site, Neoplasms by Histologic Type, Immune Checkpoint Inhibitors.
What interventions are being tested in trial NCT04572451?
The interventions under investigation include: nivolumab (DRUG), BMS-986253 (DRUG), Stereotactic Body Radiotherapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT04572451?
This trial is sponsored by Yana Najjar, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04572451 being conducted?
This trial has 2 study locations across Illinois, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04572451's enrollment target sits among peer trials
50 163rd of 266 higher than 99 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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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