NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN

Sponsor
Gruppo Oncologico del Nord-Ovest
Study ID
NCT05802290
Phase
PHASE3
Status
Completed

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

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

Interventions

  • Nivolumab 240 MG in 24 ML Injection — DRUG
    nivolumab monotherapy at 240mg flat dose as a 30-minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent

Study Details

Subjects will receive treatment with nivolumab monotherapy at 240mg flat dose as a 30 minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent. This study is designed to better evaluate the safety profile of nivolumab in a large series of patients with Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck. The primary endpoint of this study is the incidence of high-grade (CTCAE v 4.03 Grade 3 or higher), treatment-related, select adverse events.

Key Dates

Start date
Nov 27, 2017
Status verified
May 2022
Primary completion
Mar 26, 2020
Completion
Mar 26, 2020

Study Design

Enrollment
124 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nivolumab
    nivolumab monotherapy at 240mg flat dose as a 30-minute IV infusion on Day 1 of a treatment cycle every 2 weeks (14 days) until confirmed progression of disease, unacceptable toxicity, death or withdrawal of consent

Primary Outcome Measure

Incidence of high-grade (CTCAE v 4.03 Grade 3 or higher) treatment related AE [ Time Frame: From baseline to 100 days after last study treatment ]

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