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NCT02858869 · ClinicalTrials.gov registry record · Phase 1

Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases

A Phase 1 study, sponsored by Emory University.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT02858869: Completed Phase 1 study, sponsored by Emory University.

NCT02858869 is a Phase 1 study that has completed, run by Emory University. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02858869, a Phase 1 study, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

This pilot trial studies the side effects of giving pembrolizumab together with stereotactic radiosurgery to treat patients with melanoma or non-small cell lung cancer that has spread to the brain. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Giving pembrolizumab together with stereotactic radiosurgery may be a better treatment for patients with melanoma or non-small cell lung cancer that has spread to the brain.

Primary Outcome

Number of dose limiting toxicity events defined as Radiation Therapy Oncology Group grade 3 central nervous system toxicities which are irreversible severe neurological symptoms requiring medications. Toxicity events for each arm will be reported, and 95% confidence intervals will be estimated using the Clopper-Pearson method. Number of with DLT (%).

Interventions

  • BIOLOGICAL Pembrolizumab
  • RADIATION Stereotactic Radiosurgery

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2016-10-04
Est. Completion 2023-10-28
Phase Phase 1
Emory University

1,208 total trials

What the finished NCT02858869 record still lists

NCT02858869 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT02858869 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02858869 about?

NCT02858869 is a clinical study titled "Pembrolizumab and Stereotactic Radiosurgery for Melanoma or Non-Small Cell Lung Cancer Brain Metastases". This pilot trial studies the side effects of giving pembrolizumab together with stereotactic radiosurgery to treat patients with melanoma or non-small cell lung cancer that has spread to the brain. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow an...

What is the current status of trial NCT02858869?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2016-10-04. Estimated completion is 2023-10-28.

What interventions are being tested in trial NCT02858869?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Stereotactic Radiosurgery (RADIATION).

Who is sponsoring clinical trial NCT02858869?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02858869's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02858869, the US trial registry maintained by the National Library of Medicine. NCT02858869 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.