Innovative Trial for Understanding the Impact of Targeted Therapies in NF2-Related Schwannomatosis (INTUITT-NF2)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Scott R. Plotkin, MD, PhD
Study ID
NCT04374305
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ependymoma
  • Meningioma
  • Neurofibromatosis Type 2
  • Non-vestibular Schwannoma
  • Vestibular Schwannoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brigatinib — DRUG
    Oral daily per predetermined dosage per protocol.
  • Neratinib — DRUG
    Oral daily per predetermined dosage per protocol.
  • Retifanlimab — DRUG
    Every 3 weeks by IV per predetermined dose in protocol.
  • Bevacizumab — DRUG
    Every 3 weeks by IV per predetermined dose in protocol.

Study Details

This is a multi-arm phase II platform-basket screening study designed to test multiple experimental therapies simultaneously in patients with NF2-related schwannomatosis (NF2-SWN, formerly known as neurofibromatosis type 2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2-SWN to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. * Investigational Drug Sub-study A: Brigatinib * Investigational Drug Sub-study B: Neratinib * Investigational Drug Sub-study C: Retifanlimab plus bevacizumab

Key Dates

Start date
Jun 20, 2020
Status verified
May 2026
Primary completion
Dec 1, 2029
Completion
Dec 1, 2030

Study Design

Enrollment
109 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sub-study A (brigatinib) - CLOSED TO ENROLLMENT
    Subjects treated in this arm will receive brigatinib 90 mg by mouth daily for 7 days and then increased to 180 mg by mouth daily if the drug is tolerated.
  • Experimental: Sub-study B (neratinib)
    The first three participants treated in this arm will receive neratinib 200 mg mg by mouth daily. If these participants tolerate the medication well, subsequent participants will receive neratinib 240 mg by mouth daily.
  • Experimental: Experimental: sub-study C (retifanlimab plus bevacizumab)
    Subjects on this arm will receive retifanlimab by IV infusion at a dose of 375 mg every 3 weeks on a continuous schedule for 48 weeks. Subjects will also receive bevacizumab by IV infusion at a dose of 7.5 mg/kg every 3 weeks on an intermittent schedule. One cycle last 42 days and the study will last for 52 total weeks (48 treatment weeks and 4 follow-up weeks).

Primary Outcome Measure

Radiographic response rate (for each drug substudy) [ Time Frame: 2 years ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
UCLA Medical CenterLos AngelesCalifornia90095
Phioanh (Leia) Nghiemphu, MD
[email protected]
Phioanh (Leia) Nghiemphu, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Christine Dinh, MD
[email protected]
Christine Dinh, MD (PRINCIPAL_INVESTIGATOR)
Indiana University School of MedicineIndianopolisIndiana46202
Steven Rhodes, MD, PhD
[email protected]
Steven Rhodes, MD, PhD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins HospitalBaltimoreMaryland21287
Jaishri Blakeley, MD
[email protected]
Jaishri Blakeley, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02115
Scott Plotkin, MD
[email protected]
(617) 724-8770
Scott Plokin, MD (PRINCIPAL_INVESTIGATOR)
New York University Langone Medical CenterNew YorkNew York10016
Kaleb Yohay, MD
[email protected]
Kaleb Yohay, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
UCLA Medical Center· Los Angeles, CAUniversity of Miami· Miami, FLIndiana University School of Medicine· Indianopolis, INJohns Hopkins Hospital· Baltimore, MDMassachusetts General Hospital· Boston, MANew York University Langone Medical Center· New York, NY

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