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

Status: Closed to Accrual

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)

Eligibility Criteria

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

Locations & Contacts

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: Active
Name Not Available

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not Available

Florida

Jacksonville
Mayo Clinic in Florida
Status: Active
Name Not Available
Tampa
Moffitt Cancer Center
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available
Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available

Minnesota

Rochester
Mayo Clinic
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Bristol-Myers Squibb

Trial IDs

Primary ID CA209-647
Secondary IDs NCI-2016-01337, 2016-000894-19
Clinicaltrials.gov ID NCT02857426