LymphomaPhase 2CheckMate 647NCT02857426
A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
A Phase 2 study testing Nivolumab in people with Lymphoma, run by Bristol-Myers Squibb at 50 sites in 13 countries.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Nivolumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 50 sitesin 13 countries
- Study dates
- 21 Oct 2016to 24 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
50 sites in 13 countries.
50 sites in 13 countries
United States13 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-3410
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
Baylor Research Institute
Dallas, Texas, 75246
Karmanos Cancer Institute
Detroit, Michigan, 48201
City Of Hope Medical Center
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
Columbia University
New York, New York, 10032
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Swedish Medical Center
Seattle, Washington, 98122
H. Lee Moffitt Cancer Center & Research Inst, Inc
Tampa, Florida, 33612
France9 sites
Local Institution
Bordeaux, 33076
Local Institution
Caen, 14000
Local Institution
La Tronche, 3870
Local Institution
Lille, 59037
Local Institution
Paris, 75651
Centre Hospitalier Lyon Sud - UPCO
Pierre-Bénite, 69495
Local Institution
Rennes, 35033
Local Institution
Saint-Cloud, 92210
Local Institution
Tours, 37044
Japan7 sites
Local Institution
Chuo-ku, Tokyo, 1040045
Local Institution
Fukuoka, Fukuoka, 811-1395
Local Institution
Hidaka-shi, Saitama, 3501298
Local Institution
Kotoku, Tokyo, 1358550
Local Institution
Mitaka-shi, Tokyo, 181-8611
Local Institution
Nagoya, Aichi-ken, 4648681
Local Institution
Yamagata, 9909585
Israel4 sites
Local Institution
Haifa, 3109601
Local Institution
Jerusalem, 91120
Local Institution
Petah Tikva, 4941492
Local Institution
Tel Aviv, 64239
Brazil3 sites
Fundacao Pio Xii Hosp Cancer De Barretos
Barretos, São Paulo, 14784-400
Instituto Do Cancer Mae De Deus / Cor Hospital Mae De Deus
Porto Alegre, Rio Grande do Sul, 90470-340
Hospital Das Clinicas - Fmusp
São Paulo, 05403-000
Canada3 sites
CHU de Quebec
Québec, Quebec, G1J 1Z4
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
Hungary3 sites
Local Institution
Budapest, 1083
Belgyogyaszati Onkologia OOI
Budapest, 1122
Local Institution
Debrecen, 4032
Italy3 sites
Irccs Ospedale S. Raffaele
Milan, 20132
Fondazione Policlinico Universitario A. Gemelli
Roma, 00168
Istituto Clinico Humanitas
Rozzano (milano), 20089
Czechia1 site
I. interni klinika - klinika hematologie 1. LF UK a VFN v Praze
Prague, 128 08
About this study
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)
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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
Also called BMS-936558, Opdivo
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab for population with PCNSL | Experimental | Specified dose on specified days Receives: Drug: Nivolumab |
| Nivolumab for population with PTL | Experimental | Specified dose on specified days Receives: Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 51 months
Secondary outcomes (4)
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.
Measured: Up to approximately 51 months
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.
Measured: Up to approximately 51 months
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.
Measured: Up to approximately 51 months
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.
Measured: Up to approximately 51 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study start21 Oct 2016
- Primary completion11 Jun 2019
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857426
- Sponsor's protocol ID
- CA209-647
- Other IDs
- 2016-000894-19, 2016
- Acronym
- CheckMate 647
- Status last verified
- Nov 2021
- First submitted
- 3 Aug 2016
- Last updated
- 23 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02857426
- Acronym / sponsor ID
- CheckMate 647 / CA209-647
- Conditions
- Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Ono Pharmaceutical Co., Ltd.
- Study start
- 21 Oct 2016 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Posted 28 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab for population with PCNSL | Experimental | Drug: NivolumabSpecified dose on specified days |
| Nivolumab for population with PTL | Experimental | Drug: NivolumabSpecified dose on specified days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NivolumabAlso: BMS-936558, Opdivo | Drug | Nivolumab for population with PCNSL, Nivolumab for population with PTL |
Primary outcome
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.
4 secondary outcomes
BICR-Assessed Progression Free Survival (PFS)
Time frame: Up to approximately 51 months
Investigator-Assessed Objective Response Rate (ORR)
Time frame: Up to approximately 51 months
Investigator-Assessed Duration of Response (DOR)
Time frame: Up to approximately 51 months
Overall Survival (OS)
Time frame: Up to approximately 51 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
50 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab in people with Lymphoma, run by Bristol-Myers Squibb at 50 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, France, Japan, Israel, Brazil and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BICR-Assessed Objective Response Rate (ORR) (time frame: Up to approximately 51 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.