NCT03132038

Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck

A Phase II, Multicenter, Non Randomized, Open Label Study of Nivolumab In Recurrent and/or Metastatic Salivary Gland Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

INDICATION: Patients with recurrent and/or metastatic salivary glands carcinoma who have progressed during the 6 months period before entering the study and who are eligible for nivolumab monotherapy.

Detailed description

METHODOLOGY: The present study is a multicenter, open-label, non-controlled, phase II study in patients who are suffering from recurrent and/or metastatic Salivary Glands Carcinoma, who have progressed during the 6 months period before entering the study and who are eligible for nivolumab monotherapy. All eligible patients will receive nivolumab treatment for a maximum of 12 cycles of treatment. 92 eligible patients will be dosed with nivolumab intravenously over 60 minutes (± 5 minutes) at 3 mg/kg every two weeks. Each 28-day dosing period will constitute a cycle.

Conditions

• Salivary Gland Carcinoma
• Metastatic Cancer
• Recurrent Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	3 mg/kg, every two weeks, during a maximum of one year

Timeline

• Start date: 2017-03-24
• Primary completion: 2019-01-01
• Completion: 2021-10-20
• First posted: 2017-04-27
• Last updated: 2022-01-11

Locations

11 sites across 1 country: France