Actively Recruiting
VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer
Led by Emory University · Updated on 2025-07-23
50
Participants Needed
1
Research Sites
473 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
V
Vaccinex Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stage I-IVA head and neck squamous cell carcinoma confirmed by cytology or histology
- Oropharyngeal tumors must have p16 testing done
- Cancer must be surgically removable with planned surgery
- Archival tissue from within 6 months or new biopsy before treatment must be available
- No previous treatment for head and neck squamous cell carcinoma
- ECOG performance status of 0 or 1
- Absolute neutrophil count of 1,500 cells/µL or higher
- Platelets of at least 100,000/µL
- Hemoglobin level of 9.0 g/dL or higher (transfusions allowed)
- Total bilirubin no more than 1.5 times the upper normal limit
- AST and ALT no more than 2.5 times the upper normal limit
- Albumin level of 3.0 g/dL or higher
- Serum creatinine no more than 1.5 times the upper normal limit
- Calculated creatinine clearance of at least 50 mL/min
- INR of 1.5 or less; anticoagulation allowed only with low molecular weight heparin on stable dose
- Willing and able to comply with study visits, treatments, lab tests, and procedures
- Able to understand and sign informed consent
- Female subjects of childbearing potential must use adequate contraception during and 3 months after study
- Male subjects must use adequate contraception during and 3 months after study
- Female subjects of childbearing age must have a negative pregnancy test at study entry
You will not qualify if you...
- Poor venous access for study drug administration
- Nasopharynx cancer, unknown primary cancer, or sinonasal cancer
- Not a candidate for surgery due to medical conditions
- Use of chronic immunosuppressants such as cyclosporine
- Prior organ transplant or bone marrow transplant
- Active autoimmune disease except some controlled conditions like vitiligo or resolved childhood asthma
- Need for systemic corticosteroids greater than 10 mg prednisone equivalent within 14 days of treatment
- Pregnant or breastfeeding women
- Uncontrolled illness like active infection, severe heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- Other severe medical or psychiatric conditions or lab abnormalities increasing study risk or interfering with results
- Bleeding disorders or coagulopathy
- Prior invasive cancer unless disease free for at least one year
- Previous treatment for head and neck squamous cell carcinoma
- Active bacterial or fungal infections needing systemic treatment within 7 days before treatment
- Use of other investigational drugs within 28 days or 5 half-lives before study drug
- History of severe allergic reactions to monoclonal antibodies
- Non-oncology vaccines within 28 days before or after ipilimumab dose
- No archival tissue available and repeat biopsy not feasible before study treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
Research Team
C
Conor Steuer, MD
CONTACT
N
Nabil Saba, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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