Clinical trial NCT02857426: A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2016-08-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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

Primary outcomes:
measure: BICR-Assessed Objective Response Rate (ORR)
timeFrame: Up to approximately 51 months
Secondary outcomes:
measure: BICR-Assessed Progression Free Survival (PFS)
timeFrame: Up to approximately 51 months
measure: Investigator-Assessed Objective Response Rate (ORR)
timeFrame: Up to approximately 51 months
measure: Investigator-Assessed Duration of Response (DOR)
timeFrame: Up to approximately 51 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 51 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City Of Hope Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Inst, Inc
state: Florida
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Porto Alegre
country: Brazil
facility: Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
state: Rio Grande Do Sul
city: Barretos
country: Brazil
facility: Fundacao Pio Xii Hosp Cancer De Barretos
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas - Fmusp
city: Vancouver
country: Canada
facility: BC Cancer Agency - Vancouver Centre
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Quebec
country: Canada
facility: CHU de Quebec
city: Praha 2
country: Czechia
facility: I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
city: Bordeaux
country: France
facility: Local Institution
city: Caen
country: France
facility: Local Institution
city: La Tronche
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Paris cedex 13
country: France
facility: Local Institution
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud - UPCO
city: Rennes Cedex 9
country: France
facility: Local Institution
city: St. Cloud
country: France
facility: Local Institution
city: Tours Cedex 9
country: France
facility: Local Institution
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
city: Hong Kong
country: Hong Kong
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Budapest
country: Hungary
facility: Belgyogyaszati Onkologia OOI
city: Debrecen
country: Hungary
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Petah Tikva
country: Israel
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Milano
country: Italy
facility: Irccs Ospedale S. Raffaele
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Rozzano (milano)
country: Italy
facility: Istituto Clinico Humanitas
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Hidaka-shi
country: Japan
facility: Local Institution
state: Saitama
city: Chuo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Kotoku
country: Japan
facility: Local Institution
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Local Institution
state: Tokyo
city: Yamagata
country: Japan
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: