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A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL) (CheckMate 647)

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • City Of Hope Medical Center
  • Mayo Clinic Jacksonville
  • H. Lee Moffitt Cancer Center & Research Inst, Inc
  • Dana Farber Cancer Institute
  • Massachusetts General Hospital
  • Karmanos Cancer Institute
  • Mayo Clinic Rochester
  • Hackensack University Medical Center
  • Columbia University
  • Fox Chase Cancer Center
  • Baylor Research Institute
  • Swedish Medical Center
  • Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
  • Fundacao Pio Xii Hosp Cancer De Barretos
  • Hospital Das Clinicas - Fmusp
  • BC Cancer Agency - Vancouver Centre
  • Princess Margaret Cancer Centre
  • CHU de Quebec
  • I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Centre Hospitalier Lyon Sud - UPCO
  • Local Institution
  • Local Institution
  • Local Institution
  • Klinikum Stuttgart
  • Local Institution
  • Local Institution
  • Belgyogyaszati Onkologia OOI
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Irccs Ospedale S. Raffaele
  • Fondazione Policlinico Universitario A. Gemelli
  • Istituto Clinico Humanitas
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nivolumab for population with PCNSL

Nivolumab for population with PTL

Arm Description

Specified dose on specified days

Specified dose on specified days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

BICR-Assessed Progression Free Survival (PFS)
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)
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)
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)
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.

Full Information

First Posted
August 3, 2016
Last Updated
November 24, 2021
Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02857426
Brief Title
A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Acronym
CheckMate 647
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 21, 2016 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
November 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
Collaborators
Ono Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab for population with PCNSL
Arm Type
Experimental
Arm Description
Specified dose on specified days
Arm Title
Nivolumab for population with PTL
Arm Type
Experimental
Arm Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Primary Outcome Measure Information:
Title
BICR-Assessed Objective Response Rate (ORR)
Description
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.
Time Frame
Up to approximately 51 months
Secondary Outcome Measure Information:
Title
BICR-Assessed Progression Free Survival (PFS)
Description
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.
Time Frame
Up to approximately 51 months
Title
Investigator-Assessed Objective Response Rate (ORR)
Description
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.
Time Frame
Up to approximately 51 months
Title
Investigator-Assessed Duration of Response (DOR)
Description
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.
Time Frame
Up to approximately 51 months
Title
Overall Survival (OS)
Description
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.
Time Frame
Up to approximately 51 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3410
Country
United States
Facility Name
City Of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Inst, Inc
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Baylor Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
Fundacao Pio Xii Hosp Cancer De Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital Das Clinicas - Fmusp
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
BC Cancer Agency - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CHU de Quebec
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Local Institution
City
La Tronche
ZIP/Postal Code
3870
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Paris cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Centre Hospitalier Lyon Sud - UPCO
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution
City
St. Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Local Institution
City
Tours Cedex 9
ZIP/Postal Code
37044
Country
France
Facility Name
Klinikum Stuttgart
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Local Institution
City
Hong Kong
Country
Hong Kong
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Belgyogyaszati Onkologia OOI
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Local Institution
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Irccs Ospedale S. Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano (milano)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Local Institution
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
4648681
Country
Japan
Facility Name
Local Institution
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
811-1395
Country
Japan
Facility Name
Local Institution
City
Hidaka-shi
State/Province
Saitama
ZIP/Postal Code
3501298
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1040045
Country
Japan
Facility Name
Local Institution
City
Kotoku
State/Province
Tokyo
ZIP/Postal Code
1358550
Country
Japan
Facility Name
Local Institution
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Local Institution
City
Yamagata
ZIP/Postal Code
9909585
Country
Japan
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
169610
Country
Singapore

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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