Efficay and safety study of Nivolumab in subjects with Primary Central Nervous System Lymphoma (PCNSL) and Primary Testicular Lymphoma (PTL)

Phase 1

• Conditions: Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL); MedDRA version: 20.0Level: LLTClassification code 10036685Term: Primary central nervous system lymphomaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10043302Term: Testicular cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000894-19-HU
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-23
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1a) Men and women, age of more than 18 years old at the time of screening
b) Subjects with pathologically confirmed PCNSL or PTL who progressed after or did not respond to at least 1 line of systemic therapy (PCNSL prior therapy may include: high-dose methotrexate [HD-MTX], HD-MTX based regimen, high dose cytarabine, radiation therapy alone as treatment or as part of consolidation therapy, high dose therapy with autologous stem cell transplant as part of consolidation therapy, and/or intraocular MTX alone or as part of consolidation therapy; PTL prior therapy may include: chemoimmunotherapy such as CHOP-R or any other regimens, with/without prophylactic radiation to contralateral testis or orchiectomy or intrathecal chemotherapy)
c) Radiologically measurable disease within 28 days of first dose
d) Karnofsky performance status of 70 or higher
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion Criteria

a) Intraocular PCNSL without evidence of brain disease. Patients with prior history of intraocular
involvement treated only with intraocular methotrexate and no prior systemic therapy are excluded.
b) PCNSL with systemic disease
c) PCNSL patients who cannot undergo magnetic resonance imaging assessments
d) Patients with brain stem lesions
e) Active, known, or suspected autoimmune disease
f) Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency
syndrome
g) Prior treatment with an anti-programmed death ligand (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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified