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RECRUITING Phase 1

Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma

NCT04572451 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 50 participants
Start Date 2021-11-29
Est. Completion 2027-05-31
Phase Phase 1

Sponsor

Yana Najjar

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04572451

The ClinicalTrials.gov registry entry for NCT04572451 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yana Najjar, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04572451 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Illinois, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04572451?

The interventions under investigation include: nivolumab (DRUG), BMS-986253 (DRUG), Stereotactic Body Radiotherapy (SBRT) (RADIATION). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04572451?

This trial is sponsored by Yana Najjar, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial