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

ConditionSquamous Cell Carcinoma of the Head and Neck
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • VX15/2503

    Biological/Vaccine

    Given IV

  • Ipilimumab

    Biological/Vaccine

    Given IV

  • Nivolumab

    Biological/Vaccine

    Given IV

Treatment groups

50 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group A (VX15/2503)Experimental treatment 1 intervention
Group B: Group B (VX15/2503, ipilimumab)Experimental treatment 2 interventions
Group C: Group C (VX15/2503, nivolumab)Experimental treatment 2 interventions
Group D: Group D (nivolumab)Experimental treatment 1 intervention
Group E: Group E (ipilimumab)Experimental treatment 1 intervention
Group F: Group F (no treatment)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in immune profile in the tumor microenvironment

Specimens from surgical resection will be collected under the guidance of the collaborating pathologist and tissue procurement staff at the time of surgery to capture tissue in excess of that needed for clinical staging and diagnostic purposes. Tumor specimens will be fixed in 10% formalin, embedded in paraffin and biomarkers related to activated HNSCC stroma will be assessed via immunohistochemical analysis.

Time frame
Baseline up to 4-8 weeks after surgery
2

Change in circulating percentage of immune suppressor subsets in peripheral blood

Blood samples will be collected and peripheral blood mononuclear cells will be isolated from these samples and stored in -80°C freezers until analysis. Multi-parameter flow cytometry will be utilized to phenotype immune effector cells. The impact of treatment on the circulating percentage of immune suppressor subsets that may serve as predictors of response to immune checkpoint inhibition. All data will be expressed as the percentage of total circulating peripheral blood cells with each respective phenotype.

Time frame
Baseline up to 4-8 weeks after surgery
3

Phenotypic shifts in T lymphocyte subsets in peripheral blood

Blood samples will be collected and peripheral blood mononuclear cells will be isolated from these samples and stored in -80°C freezers until analysis. Blood will be analyzed by multi-parameter flow cytometry to identify systemic phenotypic shifts mediated by VX15/2503 in combination with immune checkpoint inhibition.

Time frame
Baseline up to 4-8 weeks after surgery

Secondary outcomes

1

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

Adverse events will be classified using MedDRA System Organ Classes and Preferred Terms. Furthermore, serious adverse events, adverse events (AEs) with a severity grade of 3 or above using NCI CTCAE version 4.0, AEs deemed related to study drug, AEs leading to discontinuation of study drug, and AEs leading to death will also be summarized in preferred term by system organ class and listed on an individual subject basis.

Time frame
Up to 4-8 weeks after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Vaccinex Inc.

Collaborator

Source ClinicalTrials.gov
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