Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03370276
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Head and Neck Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Cancer
  • Squamous Cell Carcinoma of the Hypopharynx
  • Squamous Cell Carcinoma of the Larynx
  • Squamous Cell Carcinoma of the Oral Cavity
  • Squamous Cell Carcinoma of the Oropharynx
  • Squamous Cell Carcinoma of the Paranasal Sinus

Eligibility Criteria

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

Interventions

  • Nivolumab — DRUG
    Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms.
  • Cetuximab — DRUG
    Cetuximab intravenously (IV) at 500 mg/m\^2 or 250 mg/m\^2 as outlined in the treatment arms.

Study Details

The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, investigators want to determine if the combination of Cetuximab and nivolumab can help people with advanced cases of HNSCC. Both cetuximab and nivolumab have been used separately to treat HNSCC and are Food and Drug Administration (FDA) approved in this type of cancer.

Key Dates

Start date
Dec 20, 2017
Status verified
Mar 2026
Primary completion
Sep 4, 2021
Completion
Dec 23, 2023

Study Design

Enrollment
95 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I - Affiliate Sites Only
    Nivolumab and dose escalation of Cetuximab. Dose Level 1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\^2; Nivolumab 240 mg. Dose Level -1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 250 mg/m\^2; Nivolumab 240 mg.
  • Experimental: Phase I - Moffitt Site Only
    Nivolumab and dose escalation of Cetuximab. Dose Level 1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 500 mg/m\^2; Nivolumab 240 mg. Dose Level -1: Lead-in Day -14 before Cycle 1 only: Cetuximab 500 mg/m\^2; Nivolumab - none. Cycle 1 Day 1 and all subsequent doses every 2 weeks (Q2W): Cetuximab 250 mg/m\^2; Nivolumab 240 mg.
  • Experimental: Phase II - Affiliate Sites Only
    Nivolumab and Cetuximab at recommended Phase II dose (RP2D).
  • Experimental: Phase II - Moffitt Site Only
    Nivolumab and Cetuximab at recommended Phase II dose (RP2D).

Primary Outcome Measure

Phase I: Maximum Tolerated Dose [ Time Frame: Up to 12 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Emory University School of MedicineAtlantaGeorgia30322-
The Ohio State UniversityColumbusOhio43210-

Find similar trials in Tampa, FL

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FLEmory University School of Medicine· Atlanta, GAThe Ohio State University· Columbus, OH

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