A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
CheckMate 647
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)
2 other identifiers
interventional
66
13 countries
50
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 lymphoma
Started Oct 2016
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedStudy Start
First participant enrolled
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2019
CompletedResults Posted
Study results publicly available
October 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 24, 2020
CompletedDecember 23, 2021
November 1, 2021
2.6 years
August 3, 2016
October 5, 2020
November 24, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
BICR-Assessed Objective Response Rate (ORR)
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.
Up to approximately 51 months
Secondary Outcomes (4)
BICR-Assessed Progression Free Survival (PFS)
Up to approximately 51 months
Investigator-Assessed Objective Response Rate (ORR)
Up to approximately 51 months
Investigator-Assessed Duration of Response (DOR)
Up to approximately 51 months
Overall Survival (OS)
Up to approximately 51 months
Study Arms (2)
Nivolumab for population with PCNSL
EXPERIMENTALSpecified dose on specified days
Nivolumab for population with PTL
EXPERIMENTALSpecified dose on specified days
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Ono Pharmaceutical Co. Ltdcollaborator
Study Sites (50)
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3410, United States
City Of Hope Medical Center
Duarte, California, 91010, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224, United States
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, 33612, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Massachusetts General Hospital
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Columbia University
New York, New York, 10032, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Baylor Research Institute
Dallas, Texas, 75246, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
Porto Alegre, Rio Grande do Sul, 90470-340, Brazil
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, São Paulo, 14784-400, Brazil
Hospital Das Clinicas - Fmusp
São Paulo, 05403-000, Brazil
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
CHU de Quebec
Québec, Quebec, G1J 1Z4, Canada
I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
Prague, 128 08, Czechia
Local Institution
Bordeaux, 33076, France
Local Institution
Caen, 14000, France
Local Institution
La Tronche, 3870, France
Local Institution
Lille, 59037, France
Local Institution
Paris, 75651, France
Centre Hospitalier Lyon Sud - UPCO
Pierre-Bénite, 69495, France
Local Institution
Rennes, 35033, France
Local Institution
Saint-Cloud, 92210, France
Local Institution
Tours, 37044, France
Klinikum Stuttgart
Stuttgart, 70174, Germany
Local Institution
Hong Kong, Hong Kong
Local Institution
Budapest, 1083, Hungary
Belgyogyaszati Onkologia OOI
Budapest, 1122, Hungary
Local Institution
Debrecen, 4032, Hungary
Local Institution
Haifa, 3109601, Israel
Local Institution
Jerusalem, 91120, Israel
Local Institution
Petah Tikva, 4941492, Israel
Local Institution
Tel Aviv, 64239, Israel
Irccs Ospedale S. Raffaele
Milan, 20132, Italy
Fondazione Policlinico Universitario A. Gemelli
Roma, 00168, Italy
Istituto Clinico Humanitas
Rozzano (milano), 20089, Italy
Local Institution
Nagoya, Aichi-ken, 4648681, Japan
Local Institution
Fukuoka, Fukuoka, 811-1395, Japan
Local Institution
Hidaka-shi, Saitama, 3501298, Japan
Local Institution
Chuo-ku, Tokyo, 1040045, Japan
Local Institution
Kotoku, Tokyo, 1358550, Japan
Local Institution
Mitaka-shi, Tokyo, 181-8611, Japan
Local Institution
Yamagata, 9909585, Japan
Local Institution
Moscow, 121309, Russia
Local Institution
Singapore, 169610, Singapore
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 5, 2016
Study Start
October 21, 2016
Primary Completion
June 11, 2019
Study Completion
November 24, 2020
Last Updated
December 23, 2021
Results First Posted
October 28, 2020
Record last verified: 2021-11