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ACTIVE NOT RECRUITING Phase 1

Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma

NCT03604978 · View on ClinicalTrials.gov ↗

Study Summary

This phase I/II trial studies the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating patients with grade II-III meningioma that has come back (recurrent). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and 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 nivolumab and multi-fraction stereotactic radiosurgery with or without ipilimumab may work better in treating patients with grade II-III meningioma.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Echocardiography Test
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Study Locations (20)

Florida

  • UM Sylvester Comprehensive Cancer Center at Aventura — Aventura
  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach
  • Mayo Clinic in Florida — Jacksonville
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
  • UM Sylvester Comprehensive Cancer Center at Kendall — Miami
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation

California

  • City of Hope Comprehensive Cancer Center — Duarte
  • UC San Diego Moores Cancer Center — La Jolla
  • Los Angeles General Medical Center — Los Angeles
  • USC / Norris Comprehensive Cancer Center — Los Angeles
  • UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange

Kansas

  • University of Kansas Cancer Center — Kansas City
  • University of Kansas Hospital-Westwood Cancer Center — Westwood

Missouri

  • Siteman Cancer Center at West County Hospital — Creve Coeur
  • Washington University School of Medicine — St Louis

Arizona

  • Mayo Clinic Hospital in Arizona — Phoenix

Colorado

  • UCHealth University of Colorado Hospital — Aurora

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore

Minnesota

  • Mayo Clinic in Rochester — Rochester

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2019-06-17
Est. Completion 2027-03-19
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03604978

The ClinicalTrials.gov registry entry for NCT03604978 describes a study currently listed as active not 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 38 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 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Recurrent Meningioma appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection 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: NCT03604978 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Kansas. 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 NCT03604978 about?

NCT03604978 is a clinical study titled "Nivolumab and Multi-fraction Stereotactic Radiosurgery With or Without Ipilimumab in Treating Patients With Recurrent Grade II-III Meningioma". This phase I/II trial studies the side effects and best dose of nivolumab when given together with multi-fraction stereotactic radiosurgery and to see how well they work with or without ipilimumab in treating patients with grade II-III meningioma that has come back (recurrent). Immunotherapy with mo...

What is the current status of trial NCT03604978?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2019-06-17. Estimated completion is 2027-03-19.

What conditions does trial NCT03604978 study?

This clinical trial studies the following conditions: Recurrent Meningioma, Grade 2 Meningioma, Grade 3 Meningioma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03604978?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Echocardiography Test (PROCEDURE), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03604978?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03604978 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Kansas. 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