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

November 24, 2021 updated by: Bristol-Myers Squibb

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)

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-000
        • Hospital das Clinicas - FMUSP
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
        • Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Fundacao Pio Xii Hosp Cancer De Barretos
  • Canada
      • Quebec, Canada, G1J 1Z4
        • CHU de Quebec
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency - Vancouver Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre
  • Czechia
      • Praha 2, Czechia, 128 08
        • I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
  • France
      • Bordeaux, France, 33076
        • Local Institution
      • Caen, France, 14000
        • Local Institution
      • La Tronche, France, 3870
        • Local Institution
      • Lille Cedex, France, 59037
        • Local Institution
      • Paris cedex 13, France, 75651
        • Local Institution
      • Pierre Benite, France, 69495
        • Centre Hospitalier Lyon Sud - UPCO
      • Rennes Cedex 9, France, 35033
        • Local Institution
      • St. Cloud, France, 92210
        • Local Institution
      • Tours Cedex 9, France, 37044
        • Local Institution
  • Germany
      • Stuttgart, Germany, 70174
        • Klinikum Stuttgart
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1083
        • Local Institution
      • Budapest, Hungary, 1122
        • Belgyogyaszati Onkologia OOI
      • Debrecen, Hungary, 4032
        • Local Institution
  • Israel
      • Haifa, Israel, 3109601
        • Local Institution
      • Jerusalem, Israel, 91120
        • Local Institution
      • Petah Tikva, Israel, 4941492
        • Local Institution
      • Tel Aviv, Israel, 64239
        • Local Institution
  • Italy
      • Milano, Italy, 20132
        • IRCCS Ospedale S. Raffaele
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli
      • Rozzano (milano), Italy, 20089
        • Istituto Clinico Humanitas
  • Japan
      • Yamagata, Japan, 9909585
        • Local Institution
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 811-1395
        • Local Institution
    • Saitama
      • Hidaka-shi, Saitama, Japan, 3501298
        • Local Institution
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution
      • Kotoku, Tokyo, Japan, 1358550
        • Local Institution
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Local Institution
  • Russian Federation
      • Moscow, Russian Federation, 121309
        • Local Institution
  • Singapore
      • Singapore, Singapore, 169610
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3410
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010
        • City of Hope Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Inst, Inc
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Research Institute
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nivolumab for population with PCNSL
Specified dose on specified days
Drug: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo
Experimental: Nivolumab for population with PTL
Specified dose on specified days
Drug: Nivolumab
Other Names:
  • BMS-936558
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BICR-Assessed Objective Response Rate (ORR)
Time Frame: 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.
Up to approximately 51 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BICR-Assessed Progression Free Survival (PFS)
Time Frame: 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.
Up to approximately 51 months
Investigator-Assessed Objective Response Rate (ORR)
Time Frame: 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.
Up to approximately 51 months
Investigator-Assessed Duration of Response (DOR)
Time Frame: 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.
Up to approximately 51 months
Overall Survival (OS)
Time Frame: 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.
Up to approximately 51 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2016

Primary Completion (Actual)

June 11, 2019

Study Completion (Actual)

November 24, 2020

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 3, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

December 23, 2021

Last Update Submitted That Met QC Criteria

November 24, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-647
  • 2016-000894-19 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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