A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
NCT ID: NCT02857426
Last Updated: 2021-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2016-10-21
2020-11-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nivolumab for population with PCNSL
Specified dose on specified days
Nivolumab
Nivolumab for population with PTL
Specified dose on specified days
Nivolumab
Interventions
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Nivolumab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease requirements on scans:
PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects should have at least 1 measurable extranodal lesion or nodal lesion
* Have tumor tissue for PD-L1 expression testing
* Must have a Karnofsky performance status of 70-100
Exclusion Criteria
* Patients with certain diseases such as active autoimmune disease, type I diabetes, hypothyroidism that needs hormone replacement, active infection, psychiatric disorder
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
PCNSL, and PTL subjects with brain or spinal cord lesion who have received doses of more than 2 mg/day of dexamethasone or equivalent within the 14 days period prior to the first dose of nivolumab are excluded
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City Of Hope Medical Center
Duarte, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Columbia University
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Baylor Research Institute
Dallas, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
Porto Alegre, Rio Grande do Sul, Brazil
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, São Paulo, Brazil
Hospital Das Clinicas - Fmusp
São Paulo, , Brazil
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CHU de Quebec
Québec, Quebec, Canada
I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
Prague, , Czechia
Local Institution
Bordeaux, , France
Local Institution
Caen, , France
Local Institution
La Tronche, , France
Local Institution
Lille, , France
Local Institution
Paris, , France
Centre Hospitalier Lyon Sud - UPCO
Pierre-Bénite, , France
Local Institution
Rennes, , France
Local Institution
Saint-Cloud, , France
Local Institution
Tours, , France
Klinikum Stuttgart
Stuttgart, , Germany
Local Institution
Hong Kong, , Hong Kong
Local Institution
Budapest, , Hungary
Belgyogyaszati Onkologia OOI
Budapest, , Hungary
Local Institution
Debrecen, , Hungary
Local Institution
Haifa, , Israel
Local Institution
Jerusalem, , Israel
Local Institution
Petah Tikva, , Israel
Local Institution
Tel Aviv, , Israel
Irccs Ospedale S. Raffaele
Milan, , Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, , Italy
Istituto Clinico Humanitas
Rozzano (milano), , Italy
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Hidaka-shi, Saitama, Japan
Local Institution
Chuo-ku, Tokyo, Japan
Local Institution
Kotoku, Tokyo, Japan
Local Institution
Mitaka-shi, Tokyo, Japan
Local Institution
Yamagata, , Japan
Local Institution
Moscow, , Russia
Local Institution
Singapore, , Singapore
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2016-000894-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-647
Identifier Type: -
Identifier Source: org_study_id