RecruitingPhase 1NCT03690986

VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer

Integrated Pilot Biomarker Trial of VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer


Sponsor

Emory University

Enrollment

50 participants

Start Date

Nov 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial studies how well anti-semaphorin 4D (SEMA4D) monoclonal antibody VX15/2503 (VX15/2503) with or without ipilimumab and/or nivolumab work in treating patients with stage I-IVA head and neck squamous cell cancer. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug combination — VX15/2503 (an experimental antibody) combined with either ipilimumab or nivolumab (both immune-boosting drugs) — given before surgery to patients with head and neck cancer, to see if this approach can shrink tumors and improve outcomes. **You may be eligible if...** - You have been diagnosed with head and neck squamous cell carcinoma (a type of cancer in the mouth, throat, or related areas), at stages I through IVA - Your cancer is confirmed to be removable by surgery - You have not received any prior treatment for this head and neck cancer - You are well enough to carry out daily activities (ECOG 0 or 1) - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - You have poor vein access for receiving the study drug - You have nasopharynx cancer or cancer of unknown primary origin - You have an active autoimmune disease requiring immune-suppressing treatment - You have had a prior stem cell transplant - You are pregnant or breastfeeding - You are currently receiving other immunosuppressive therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALVX15/2503

Given IV

BIOLOGICALIpilimumab

Given IV

BIOLOGICALNivolumab

Given IV


Locations(1)

Emory University Hospital Midtown

Atlanta, Georgia, United States

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NCT03690986


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