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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

Must not have

Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab

Determined not to be a surgical candidate due to medical co-morbidities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4-8 weeks after surgery

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

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

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I haven't had vaccines not related to cancer within 4 weeks of receiving ipilimumab.

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I cannot have surgery because of other health problems.

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I am on long-term immunosuppressants like cyclosporine.

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I have had an organ or bone marrow transplant from another person.

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I am not pregnant or breastfeeding.

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I haven't taken any experimental drugs recently.

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I have a bleeding disorder or a condition affecting blood clotting.

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I have not had previous treatments for head and neck cancer.

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I have not had serious infections needing treatment in the last week.

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I don't have previous biopsy samples available, and cannot undergo another biopsy.

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I have poor veins for receiving medication.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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My cancer is in the nasopharynx, unknown primary, or sinonasal area.

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

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

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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