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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

2B4 Cell Count

4-1BB Cell Count

4-1BBL Cell Count

+36 more

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

~2620

Nivolumab

2014

Completed Phase 3

~4750

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,902 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,046 Total Patients Enrolled

Jaishri Blakeley, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Immunotherapy with Nivolumab and Ipilimumab Clinical Trial Eligibility Overview. Trial Name: NCT04465643 — Phase 1

Neurofibromatosis Research Study Groups: Immunotherapy with Nivolumab and Ipilimumab

Neurofibromatosis Clinical Trial 2023: Immunotherapy with Nivolumab and Ipilimumab Highlights & Side Effects. Trial Name: NCT04465643 — Phase 1

Immunotherapy with Nivolumab and Ipilimumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04465643 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What specific outcomes is this medical experiment aiming to accomplish?

"As conveyed by the study sponsor, Bristol-Myers Squibb, this clinical trial will measure its primary outcome over a period of up to two years. Specifically, it seeks to determine the feasibility of using a combination therapy consisting of nivolumab and ipilimumab in relation to number of participants achieving positive results. Additionally, secondary objectives such as changes in pain levels via PROMIS or Pain Interference Index surveys at various time intervals are being analysed alongside safety concerns which is evaluated through CTCAE v5.0 grading scale."

Answered by AI

What afflictions can this remedy alleviate?

"This therapy is often used to treat pre-existing anti-angiogenic conditions, but has been found to be beneficial for treating malignant neoplasms, inoperable melanoma, and squamous cell carcinoma."

Answered by AI

Has this particular therapy attained governmental backing?

"Due to the lack of pre-existing safety and efficacy data, this treatment was rated a 1 on our team's scale. This is a Phase 1 trial, meaning it is at an early stage in its clinical development."

Answered by AI

Could you provide a synopsis of the prior investigations that have used this therapy?

"Currently, 764 studies are underway to research this intervention. Of those trials, 86 have reached Phase 3 levels of progress. Pittsburgh is the epicentre for much of these investigations; however numerous other sites across 42760 locations also dedicate resources towards trialing this medication."

Answered by AI

What is the sample size for this clinical trial?

"Indeed, the information on clinicaltrials.gov demonstrates that this research is actively searching for participants. This medical endeavor was initially published on June 8th 2021 and has been recently modified as of June 16th 2022. 18 patients must be enlisted from 1 location."

Answered by AI

Is participation in this medical research still open?

"Affirmative. According to the clinicaltrials.gov website, this trial is still enrolling and was first posted on June 8th 2021 with the last update occurring on June 16th 2022. 18 individuals are required for participation at one medical centre."

Answered by AI

Am I eligible to be a participant in this clinical trial?

"In order to secure a spot in this clinical trial, applicants must be afflicted with nerve sheath tumors and their ages should range from 12 to 100 years old. This medical experiment is currently accepting 18 participants."

Answered by AI

Is the age limit for participants in this trial beyond seventy years?

"This medical trial is open to participants from age 12 to 100. There are 67 studies designated for minors and 767 designed for seniors over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neoadjuvant Nivolumab Plus Ipilimumab for Newly Diagnosed Malignant Peripheral Nerve Sheath Tumor

2021. "Neoadjuvant Nivolumab Plus Ipilimumab for Newly Diagnosed Malignant Peripheral Nerve Sheath Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04465643.

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