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

Lymphoma Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02857426
• Other study ID #: CA209-647
• Secondary ID: 2016-000894-19
• Status: Completed
• Phase: Phase 2
• Start date: October 21, 2016
• Est. completion date: November 24, 2020

Study information

• Verified date: November 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 24, 2020
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Nivolumab

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  Czechia,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Russian Federation,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to approximately 51 months
Secondary	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.	Up to approximately 51 months
Secondary	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.	Up to approximately 51 months
Secondary	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.	Up to approximately 51 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form