A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
- Registration Number
- NCT02857426
- Lead Sponsor
- Bristol-Myers Squibb
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nivolumab for population with PCNSL Nivolumab Specified dose on specified days Nivolumab for population with PTL Nivolumab Specified dose on specified days
- Primary Outcome Measures
Name Time Method BICR-Assessed Objective Response Rate (ORR) Up to approximately 51 months Percentage of participants with a confirmed objective response rate (ORR) by blinded independent central review (BICR) assessment was analyzed and reported for both PCNSL and PTL patient populations.
This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort.
- Secondary Outcome Measures
Name Time Method BICR-Assessed Progression Free Survival (PFS) Up to approximately 51 months Progression-free survival (PFS) is defined as the time from first dosing date to the date of the first documented progression using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first.
Investigator-Assessed Objective Response Rate (ORR) Up to approximately 51 months Percentage of participants with a confirmed objective response rate (ORR) by investigator assessment was analyzed and reported for both PCNSL and PTL patient populations.
This endpoint is further defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR), based on the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, divided by the number of treated participants within each cohort.Investigator-Assessed Duration of Response (DOR) Up to approximately 51 months Duration of response (DOR) by investigator assessment was analyzed and reported for both PCNSL and PTL patient populations.
This endpoint is further defined as the time from first response (CR or PR) to the date of initial objectively documented progression as determined using the IPCG Criteria for PCNSL and Lugano 2014 response evaluation for PTL, as determined by BICR, or death due to any cause, whichever occurs first.Overall Survival (OS) Up to approximately 51 months Overall survival (OS) was analyzed and reported for both PCNSL and PTL patient populations.
OS is defined as the time from first dosing date to the date of death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive.
Trial Locations
- Locations (27)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
City Of Hope Medical Center
🇺🇸Duarte, California, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Klinikum Stuttgart
🇩🇪Stuttgart, Germany
BC Cancer Agency - Vancouver Centre
🇨🇦Vancouver, British Columbia, Canada
Belgyogyaszati Onkologia OOI
ðŸ‡ðŸ‡ºBudapest, Hungary
Istituto Clinico Humanitas
🇮🇹Rozzano (milano), Italy
Fundacao Pio Xii Hosp Cancer De Barretos
🇧🇷Barretos, Sao Paulo, Brazil
Hospital Das Clinicas - Fmusp
🇧🇷Sao Paulo, Brazil
Irccs Ospedale S. Raffaele
🇮🇹Milano, Italy
CHU de Quebec
🇨🇦Quebec, Canada
Fondazione Policlinico Universitario A. Gemelli
🇮🇹Roma, Italy
Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Local Institution
🇸🇬Singapore, Singapore
Centre Hospitalier Lyon Sud - UPCO
🇫🇷Pierre Benite, France
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Columbia University
🇺🇸New York, New York, United States
H. Lee Moffitt Cancer Center & Research Inst, Inc
🇺🇸Tampa, Florida, United States
I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
🇨🇿Praha 2, Czechia
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States