Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 92
Summary
- Conditions
- Metastatic Cancer
- Recurrent Cancer
- Salivary Gland Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 monotherap...
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.
Tracking Information
- NCT #
- NCT03132038
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jérôme FAYETTE, MD Léon Bérard Center
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