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Nivolumab + Ipilimumab for Neurofibrosarcoma

Phase 1

Recruiting

Led By Jaishri Blakeley, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky Performance Scale ≥ 60%

Normal organ and marrow function on routine laboratory tests

Must not have

Active infection requiring therapy, including known positive tests for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA)

A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new cancer treatment for patients with Neurofibromatosis Type 1 who have benign or cancerous tumors.

Who is the study for?

This trial is for individuals with Neurofibromatosis Type 1 (NF1) and newly diagnosed nerve sheath tumors who can undergo surgery. Participants must have good physical function, no contraindications to the study drugs, stable tumors not requiring treatment within a year, measurable disease, normal organ/marrow function, and not be pregnant or breastfeeding. Those with active infections, severe medical conditions, autoimmune diseases or recent immunosuppressant use are excluded.

What is being tested?

The trial tests Nivolumab plus Ipilimumab given before standard treatments like surgery in patients with malignant peripheral nerve sheath tumors related to NF1. The goal is to assess the safety and feasibility of this combination therapy as an initial step before any other therapeutic procedures.

What are the potential side effects?

Nivolumab and Ipilimumab may cause immune-related side effects such as inflammation in various organs including skin rash or endocrine issues; gastrointestinal problems like diarrhea; liver toxicity; fatigue; potential lung issues like pneumonitis; infusion reactions during drug administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can care for myself but may need occasional help.

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My blood tests for organ and bone marrow function are normal.

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I am post-menopausal or not currently pregnant.

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I have no known allergies or adverse reactions to Nivolumab or Ipilimumab.

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My tumor is confirmed as a type of nerve sheath tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have an active infection needing treatment, including Hepatitis B or C.

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I haven't taken high-dose steroids or other immune-weakening drugs in the last 2 weeks.

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I am allergic to medications similar to Nivolumab or Ipilimumab.

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I am receiving chemotherapy or a trial drug for my newly diagnosed atypical neurofibroma or MPNST.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have or had an autoimmune disease or needed steroids/immunosuppressants.

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I have been diagnosed with HIV.

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My target lesions have received radiation of 8000 cGy or more.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of combination nivolumab and ipilimumab as assessed by number of participants who achieve a response

Feasibility of combination nivolumab and ipilimumab as assessed by number of participants who experience adverse events

Maximum Tolerated Dose (MTD) as determined by number of participants with dose limiting toxicities (DLT)

+1 more

Secondary study objectives

Change in pain levels in relation to target tumor as assessed by the Numeric Rating Scale

Change in pain levels in relation to target tumor as assessed by the Pain Interference Index

Change in pain levels in relation to target tumor as assessed by the Patient-Reported Outcome Measurement Information System

+1 more

Other study objectives

2B4 Cell Count

4-1BB Cell Count

4-1BBL Cell Count

+36 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Immunotherapy with Nivolumab and IpilimumabExperimental Treatment2 Interventions

Nivolumab 4.5 mg/kg every 3 weeks (Q3W) x 2 Ipilimumab 1 mg/kg Q3W x 2 Nivolumab monotherapy 4.5mg/kg Q3W concurrent with standard therapy Nivolumab monotherapy should be held for at least 2 weeks before and 2 weeks after surgery

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~3140

Nivolumab

2014

Completed Phase 3

~5220