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NCT03604978 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Recurrent Meningioma and Grade 2 Meningioma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
38
Enrollment target
20
Study locations

NCT03604978: Active Phase 1 study of Recurrent Meningioma and Grade 2 Meningioma, sponsored by National Cancer Institute (NCI).

NCT03604978 is a Phase 1 study of Recurrent Meningioma and Grade 2 Meningioma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 38 participants, below the 47-participant average among 6 other Recurrent Meningioma trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03604978, a Phase 1 study of Recurrent Meningioma and Grade 2 Meningioma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
38 participants
Enrollment target
20
Study locations

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.

Conditions Studied

Recurrent Meningioma Grade 2 Meningioma Grade 3 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
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT03604978 still lists

NCT03604978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 47-participant average among 6 other Recurrent Meningioma trials with a reported enrollment target (19% lower).

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.

NCT03604978 names 20 study sites across 8 states, led by Florida, California, Kansas.

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.

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).

Who is sponsoring clinical trial NCT03604978?

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

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.

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Related registry views

Source: ClinicalTrials.gov NCT03604978, the US trial registry maintained by the National Library of Medicine. NCT03604978 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.