VX15/2503 in Combination With Ipilimumab or Nivolumab in Patients With Head and Neck Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University
About this trial
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 criteria
Qualifiers
Stage I-IVA cytologically or histologically-proven head and neck squamous cell carcinoma (HNSCC), p16 positive and negative allowed
Oropharyngeal tumors must have p16 testing done
Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection
Archival tissue prior to treatment available from at most 6 months prior to study enrollment. Otherwise new pre-treatment biopsy mandatory
Disqualifiers
Poor venous access for study drug administration
Nasopharynx cancer, cancer of unknown primary, sinonasal cancer
Determined not to be a surgical candidate due to medical co-morbidities
Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
Trial design
Treatments tested in this trial
- VX15/2503
- Ipilimumab
- Nivolumab
Treatment groups
50 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Emory University
Lead sponsor
Vaccinex Inc.
Collaborator
Source ClinicalTrials.gov