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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT03690986
Phase
PHASE1
Status
Recruiting
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Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VX15/2503 — BIOLOGICAL
    Given IV
  • Ipilimumab — BIOLOGICAL
    Given IV
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

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.

Key Dates

Start date
Nov 1, 2018
Status verified
Jun 2025
Primary completion
Jun 4, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A (VX15/2503)
    Patients receive VX15/2503 IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.
  • Experimental: Group B (VX15/2503, ipilimumab)
    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.
  • Experimental: Group C (VX15/2503, nivolumab)
    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.
  • Experimental: Group D (nivolumab)
    Patients receive nivolumab IV over 60 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.
  • Experimental: Group E (ipilimumab)
    Patients receive ipilimumab IV over 90 minutes on day 1. Beginning days 17-36, patients undergo standard of care surgery.
  • No Intervention: Group F (no treatment)
    Patients undergo standard of care surgery.

Primary Outcome Measure

Change in immune profile in the tumor microenvironment [ Time Frame: Baseline up to 4-8 weeks after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital MidtownAtlantaGeorgia30308
Adedolapo Adedayo, MBBS
[email protected]
404-686-3925

Find similar trials in Atlanta, GA

By research site
Emory University Hospital Midtown· Atlanta, GA

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