A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/17/2019
Start Date:October 18, 2016
End Date:December 6, 2019
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Email:Clinical.Trials@bms.com

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A Phase 2, Open-label, Single-arm, Two-cohort Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Relapsed/Refractory Primary Testicular Lymphoma (PTL)

The purpose of this study is to determine whether Nivolumab is effective in the treatment of
Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory
Primary Testicular Lymphoma (PTL)


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- Pathologically confirmed PCNSL or PTL who failed or did not respond to at least 1 line
of systemic therapy

- 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:

- a) Intraocular PCNSL without evidence of brain disease b) PCNSL patients who cannot
undergo MRI assessments c) PCNSL patients with systemic disease

- 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

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
21
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-632-6119
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-934-1842
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Phone: 212-342-2959
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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New York, NY
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Phone: 215-662-7662
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-6119
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Charlotte, North Carolina 28211
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Charlotte, NC
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Phone: 216-444-8923
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Phone: 214-818-8471
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Detroit, Michigan 48201
Phone: 313-576-9381
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Duarte, California 91010
Phone: 626-218-9108
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Phone: 551-996-5168
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Jacksonville, Florida 32216
Phone: 904-953-7290
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Jacksonville, FL
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333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Phone: 203-737-4833
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-449-1307
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Philadelphia, Pennsylvania 19111
Phone: 215-728-2207
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Pittsburgh, Pennsylvania 15213
Phone: 412-623-1420
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Porto Alegre, RIO Grande DO SUL 90470
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Phone: 507-284-5484
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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San Francisco, California 94115
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Phone: 206-386-3878
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Tampa, Florida 33612
Phone: 813-745-1706
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