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

Description

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)

Study Start Date

October, 18 2016

Estimated Completion Date

December 2019

Interventions

  • Drug: Nivolumab

Study ID

Bristol-Myers Squibb -- CA209-647

Status

Recruiting

Trial ID

NCT02857426

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

65

Sponsor

Bristol-Myers Squibb

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (19)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.4 miles Lakshmi Nayak Site 0013 617-632-6119 None
Dana Farber Cancer Institute - Boston, Massachusetts 2.4 miles Lakshmi Nayak Site 0001 617-632-6119 None
Yale Cancer Center - New Haven, Connecticut 119.2 miles Kevin Becker Site 0029 203-737-4833 None
Columbia University - New York, New York 181.2 miles Fabio Iwamoto Site 0004 212-342-2959 None
Hackensack University Medical Center - Hackensack, New Jersey 183.7 miles Samuel Singer Site 0006 551-996-5168 None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Connie Batlevi Site 0009 646-449-1307 None
Fox Chase Cancer Center - Philadelphia, Pennsylvania 261.7 miles Philip Pancari Site 0011 215-728-2207 None
Hospital Of The University Of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Donald Tsai Site 0012 215-662-7662 None
University Of Pittsburgh Medical Center Cancer Center - Pittsburgh, Pennsylvania 477.2 miles Jan Drappatz Site 0008 412-623-1420 None
Cleveland Clinic Foundation - Cleveland, Ohio 544.9 miles David Peereboom Site 0042 216-444-8923 None
Karmanos Cancer Institute - Detroit, Michigan 611.5 miles Radhakrishnan Ramchandren Site 0003 313-576-9381 None
Levine Cancer Institute - Charlotte, North Carolina 720.9 miles None None None
Mayo Clinic Jacksonville - Jacksonville, Florida 1,015.8 miles Han Tun Site 0060 904-953-7290 None
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles Patrick Johnston Site 0005 507-284-5484 None
H Lee Moffitt Cancer Center Research Inst Inc - Tampa, Florida 1,178.7 miles Celeste Bello Site 0040 813-745-1706 None
Baylor Research Institute - Dallas, Texas 1,549.2 miles Andrew Whiteley Site 0032 None None
Swedish Medical Center - Seattle, Washington 2,488.3 miles Jerome Graber Site 0061 206-386-3878 None
City Of Hope Medical Center - Duarte, California 2,578.2 miles Alex Herrera Site 0010 626-218-0478 None
UCSF Medical Center - San Francisco, California 2,699.8 miles James Rubenstein Site 0046 None None

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