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

Completed · Phase 2

Conditions studied: Lymphoma

In brief

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)

Key facts

Study ID

NCT02857426

Run by

Bristol-Myers Squibb

People needed

66

Starts

2016-10-21

Expected to finish

2020-11-24

Last updated by the study team

2021-12-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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