Study of Safety and Tolerability of Nivolumab Treatment Alone or in Combination With Relatlimab or Ipilimumab in Head and Neck Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Dan Zandberg
Study ID
NCT04080804
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    A fully human anti-programmed death 1 (PD-1) monoclonal antibody checkpoint inhibitor, that blocks a signal that prevents activated T cells from attacking the cancer cells.
  • Relatlimab — DRUG
    A monoclonal antibody with anti-Lymphocyte-activation gene 3 (LAG-3) (immune checkpoint receptor protein found on the cell surface) activity.
  • Ipilimumab — DRUG
    A monoclonal anitibody that targets CTLA-4, a protein receptor, that down regulates the immune system.

Study Details

The aim of this study is to potentiate adaptive immunity to enhance the anti-tumor activity of anti-PD1 antibody by the addition of anti-CTLA4 antibody or anti-LAG3 antibody (relatlimab) given in subjects with resectable locally advanced HNSCC prior to surgical resection.

Key Dates

Start date
Dec 20, 2019
Status verified
Apr 2026
Primary completion
Jul 17, 2026
Completion
Oct 17, 2026

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + Relatlimab
    Nivolumab 480mg IV + Relatlimab 480mg IV D1 - optional Nivolumab 480 mg IV + Relatlimab 480mg IV D28 (D28 at clinician discretion i.e. surgery postponed)
  • Experimental: Nivolumab + Ipilimumab
    Nivolumab 3 mg/kg IV + Ipilimumab 1 mg/kg D1 then Nivolumab 3 mg /kg D14 and then optional Nivolumab 3 mg/kg D28 (D28 at clinician discretion i.e., surgery postponed)

Primary Outcome Measure

Adverse Events related to treatment of nivolumab in combination with relatlimab [ Time Frame: Up to 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

Find similar trials in Pittsburgh, PA

By research site
UPMC Hillman Cancer Center· Pittsburgh, PA

Related Studies