NCT03690986

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: To evaluate the effect of VX15/2503 alone and VX15/2503 in combination with immune checkpoint inhibitors, ipilimumab or nivolumab, on the immune profile in the tumor microenvironment and in peripheral blood. SECONDARY OBJECTIVE: To extend the previously reported safety profile of single agent VX15/2503 to the combination of VX15/2503 and immune checkpoint inhibitors, ipilimumab or nivolumab, in patients with head and neck squamous cell carcinoma. OUTLINE: Patients are randomized to 1 of 6 groups. GROUP A: Patients receive VX15/2503 intravenously (IV) over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery. GROUP B: 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 C: 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 D: Patients receive nivolumab IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery. GROUP E: Patients receive ipilimumab IV over 90 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery. GROUP F: Patients undergo standard of care surgery.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
BIOLOGICAL	VX15/2503	Given IV
BIOLOGICAL	Ipilimumab	Given IV
BIOLOGICAL	Nivolumab	Given IV

Timeline

• Start date: 2018-11-01
• Primary completion: 2026-06-04
• Completion: 2027-11-30
• First posted: 2018-10-01
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study