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NCT03173950 · ClinicalTrials.gov registry record · Phase 2

Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS Cancers

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
133
Enrollment target

NCT03173950: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT03173950 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 133 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03173950, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
133 participants
Enrollment target

Study Summary

Background: More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an effective treatment for people with rare CNS tumors. Objectives: To learn if stimulating the immune system using the drug nivolumab can shrink tumors in people with rare CNS (brain or spine) tumors or increase the time it takes for these tumors to grow or spread. Eligibility: Adults whose rare CNS tumor has returned. Design: Individuals will be screened: * Heart and blood tests * Physical and neurological exam * Hepatitis tests * Pregnancy test * MRI. They will lay in a machine that takes pictures. * Tumor tissue sample. This can be from a previous procedure. At the start of the study, participants will have blood tests. They will answer questions about their symptoms and their quality of life. Individuals will get nivolumab in a vein every 2 weeks for up to 64 weeks. Individuals will have monthly blood tests. Every other month they will have an MRI and a neurologic function test. They will also answer questions about their quality of life. Genetic tests will be done on individuals' tumor tissue. Individuals will be contacted if any clinically important results are found. After treatment ends, individuals will be monitored for up to 5 years. They will have a series of MRIs and neurological function tests. They will be asked to report any symptoms they experience....

Interventions

  • DRUG Nivolumab

Trial Details

FieldValue
Enrollment Target 133 participants
Start Date 2017-07-13
Est. Completion 2025-06-23
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT03173950

The ClinicalTrials.gov registry entry for NCT03173950 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 133 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Nivolumab is the first listed.

NCT03173950 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03173950 about?

NCT03173950 is a clinical study titled "Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS Cancers". Background: More than 130 primary tumors of the central nervous system (CNS) have been identified. Most affect less than 1,000 people in the United States each year. Because these tumors are so rare, there are few proven therapies. This study will test whether the immunotherapy drug nivolumab is an...

What is the current status of trial NCT03173950?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 133 participants. The study started on 2017-07-13. Estimated completion is 2025-06-23.

What interventions are being tested in trial NCT03173950?

The interventions under investigation include: Nivolumab (DRUG).

Who is sponsoring clinical trial NCT03173950?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.