NCT05802290

NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy SCCHN

A Single-Arm, Open-Label, Multicenter, Phase IIIb Clinical Trial With NIVolumab in Subjects With Recurrent or Metastatic Platinum-refrACTORy Squamous Cell Carcinoma of the Head and Neck (SCCHN) - NIVACTOR Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Gruppo Oncologico del Nord-Ovest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This clinical trial has established head and neck squamous cell carcinoma as responsive to immunotherapy and nivolumab as a new potential SOC for these patients. As concern safety, high-grade (CTCAE v4.03 Grade 3 or higher), treatment-related, select adverse events occur with a low frequency in patients with Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN) treated with nivolumab monotherapy. Nonetheless, this observation arises from patients treated in clinical trial and selected according to clear inclusion and exclusion criteria. Therefore they may not precisely reflect the clinical practice. Using a single large study is warranted in order to expand the safety database and to improve the knowledge on estimated incidence of uncommon, select, high-grade AEs.

Conditions

• Squamous Cell Carcinoma of Head and Neck

Interventions

Type	Name	Description
DRUG	Nivolumab 240 MG in 24 ML Injection	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

Timeline

• Start date: 2017-11-27
• Primary completion: 2020-03-26
• Completion: 2020-03-26
• First posted: 2023-04-06
• Last updated: 2023-04-06

Locations

23 sites across 1 country: Italy