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Checkpoint Inhibitor

VX15/2503 + Immunotherapy for Head and Neck Cancer

Phase 1

Recruiting

Led By Conor Steuer, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection

Oropharyngeal tumors must have p16 testing done

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4-8 weeks after surgery

Awards & highlights

Study Summary

This trial is studying how well VX15/2503, with or without ipilimumab and/or nivolumab, works in treating patients with stage I-IVA head and neck squamous cell cancer.

Who is the study for?

This trial is for adults with stage I-IVA head and neck squamous cell carcinoma (HNSCC) that can be surgically removed. They must not have had prior HNSCC treatment, should have proper liver and kidney function, no severe allergies to monoclonal antibodies or autoimmune diseases, and agree to use contraception. Pregnant women or those on immunosuppressants are excluded.Check my eligibility

What is being tested?

The study tests VX15/2503 alone or combined with ipilimumab/nivolumab in treating early-stage HNSCC. It's a phase I trial aiming to see how well these monoclonal antibodies prevent cancer growth and spread by interfering with tumor cells.See study design

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation of organs, skin rashes, digestive issues; fatigue; allergic reactions specific to the drugs being tested; increased risk of infections due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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My cancer can be removed with surgery.

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My throat cancer has been tested for p16.

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I am of childbearing age and have a negative pregnancy test.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney function, measured by creatinine clearance, is 50 mL/min or less.

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I have not received any treatment for head and neck cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 4-8 weeks after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 4-8 weeks after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4-8 weeks after surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in circulating percentage of immune suppressor subsets in peripheral blood

Change in immune profile in the tumor microenvironment

Phenotypic shifts in T lymphocyte subsets in peripheral blood

Secondary outcome measures

Incidence of adverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: Group E (ipilimumab)Experimental Treatment1 Intervention

Patients receive ipilimumab IV over 90 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

Group II: Group D (nivolumab)Experimental Treatment1 Intervention

Patients receive nivolumab IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

Group III: Group C (VX15/2503, nivolumab)Experimental Treatment2 Interventions

Patients receive VX15/2503 IV over 60 minutes and nivolumab IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

Group IV: Group B (VX15/2503, ipilimumab)Experimental Treatment2 Interventions

Patients receive VX15/2503 IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

Group V: Group A (VX15/2503)Experimental Treatment1 Intervention

Patients receive VX15/2503 IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.

Group VI: Group F (no treatment)Active Control1 Intervention

Patients undergo standard of care surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VX15/2503

2012

Completed Phase 2

~400

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,639 Previous Clinical Trials

2,560,596 Total Patients Enrolled

Vaccinex Inc.Industry Sponsor

11 Previous Clinical Trials

703 Total Patients Enrolled

Conor Steuer, MDPrincipal Investigator - Emory University

Emory University Hospital Midtown, Select Specialty Hospital-Atlanta

New York University School Of Medicine (Medical School)

2 Previous Clinical Trials

119 Total Patients Enrolled

Frequently Asked Questions

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

Has the efficacy of VX15/2503 been evaluated in previous experiments?

"At present, there are 768 clinical trials that involve VX15/2503. Of those active studies, 86 have reached the third phase. Pittsburgh is home to the majority of these investigations; nevertheless, 42810 research centres across multiple states and countries are currently studying this medication's efficacy."

Answered by AI

What ailments has VX15/2503 shown to be efficacious in addressing?

"VX15/2503 is a popular treatment for anti-angiogenic therapy, but it can also be employed to battle malignant neoplasms, irresectable melanoma, and squamous cell carcinoma."

Answered by AI

What is the cumulative figure of participants enrolled in this research endeavor?

"Correct. Data hosted on clinicaltrials.gov confirms that this medical study, which was first posted on November 1st 2018, is actively seeking participants. Fifty patients are needed at a single research facility to conduct the trial."

Answered by AI

Is this experiment actively looking for participants?

"Affirmative. The data on clinicaltrials.gov verifies that this research, which was initially released on November 1st 2018, is actively seeking participants. A total of 50 individuals from one medical centre are required for the trial."

Answered by AI