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

Summary

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

Conditions

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

Interventions

DRUG

Brigatinib

Oral daily per predetermined dosage per protocol.

DRUG

Neratinib

Oral daily per predetermined dosage per protocol.

DRUG

Retifanlimab

Every 3 weeks by IV per predetermined dose in protocol.

DRUG

Bevacizumab

Every 3 weeks by IV per predetermined dose in protocol.

Sponsors & Collaborators

• Takeda

  collaborator INDUSTRY

• The Children's Tumor Foundation

  collaborator OTHER

• National Comprehensive Cancer Network

  collaborator NETWORK

• Incyte Corporation

  collaborator INDUSTRY

• Scott R. Plotkin, MD, PhD

  lead OTHER

Principal Investigators

• Scott Plotkin, MD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-20

Primary Completion

2029-12-01

Completion

2030-12-01

FDA Drug

Yes

Countries

• United States

Study Locations