Spots Global Cancer Trial Database for Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck
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Trial Identification
Brief Title: Nivolumab in Recurrent or Metastatic Salivary Gland Carcinoma of the Head and Neck
Official Title: A Phase II, Multicenter, Non Randomized, Open Label Study of Nivolumab In Recurrent and/or Metastatic Salivary Gland Carcinoma of the Head and Neck
Study ID: NCT03132038
Interventions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU Bordeaux, Bordeaux, , France
Centre Georges François Leclerc, Dijon, , France
Centre Léon Bérard, Lyon, , France
ICM Val d'Aurelle, Montpellier, , France
Centre Antoine Lacassagne, Nice, , France
Institut Curie, Paris, , France
Institut Curie Saint Cloud, Saint Cloud, , France
Centre René Gauducheau, Saint-Herblain, , France
Centre Paul Strauss, Strasbourg, , France
Institut de cancérologie Alexis Vautrin, Vandoeuvre les Nancy, , France
Gustave Roussy, Villejuif, , France
Contact Details
Name: Jérôme FAYETTE, MD
Affiliation: Léon Bérard Center
Role: PRINCIPAL_INVESTIGATOR
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