Spots Global Cancer Trial Database for Nivolumab in Patients With Recurrent Malignant Mesothelioma
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Trial Identification
Brief Title: Nivolumab in Patients With Recurrent Malignant Mesothelioma
Official Title: A Single Arm Phase II Study of Nivolumab in Patients With Recurrent Malignant Pleural Mesothelioma: Interim Biopsy Analysis to Determine Efficacy. Acronym: NivoMes Study
Study ID: NCT02497508
Conditions
Interventions
Study Description
Brief Summary: This is a prospective, single arm, phase II trial in previously treated patients with MPM who are considered candidates for immunotherapy and repeat thoracoscopies/transthoracic biopsies. Nivolumab will be administered 3 mg/kg q2 weeks by intravenous injection. The administration of nivolumab as monotherapy will improve DCR form 20% to 40% at 12 weeks when compared to DCR of patients treated with best supportive care based on historical controls.
Detailed Description: Patients will undergo pre- and post-treatment thoracoscopies/biopsies.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Paul Baas, MD, PhD
Affiliation: The Netherlands Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
Name: Josine Quispel-Janssen, MD
Affiliation: The Netherlands Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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