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← Primary Central Nervous System Lymphoma

NCT03255018 · STUDY IN CONTEXT

Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Response was assessed by the International Working Group (IWG) response criteria which utilizes computed tomography (CT) scan to measure lymph node masses to assess response, bone marrow biopsies and aspirates done only if positive at the time of diagnosis or if clinically indicated. Response is calculated by measuring the sum of the products of all target lesions and then calculating the percent change from baseline or nadir. Products are calculated by multiplying the longest length by the perpendicular width of each target lesion. Confirmed complete response is \<1 cm lymph nodes/lymph node masses; unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease in size of lymph node masses; partial response is ≥50% decrease in size of lymph nodes/lymph node masses; and progression is \>50% new or increased lymph node masses/lymph nodes. Complete response (confirmed) followed by complete response(unconfirmed) and partial response are associated with better outcomes in that order.

9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.

→

secondary · POSTED

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

9/10 participants are analyzed in the DLBCL cohort because 1 participant enrolled in the DLBCL cohort was not evaluable due to withdrawal of consent prior to treatment.

→

secondary · POSTED

The response rate is calculated by dividing the number of participants that had a complete response (CR) or partial response (PR) to therapy measured on positron emission tomography (PET) scan in accordance with the 5-point Lugano classification. Best overall response is the best response (complete or partial response) recorded from the start of the treatment until disease progression/recurrence. The 5-Point Scale Deauville criteria scores the most intense uptake in a site of initial disease: no uptake or no residual uptake, slight uptake, but above blood pool, uptake above mediastinal but below or =to uptake in liver, uptake slightly to moderately higher than liver, \& markedly increased uptake. 5Point Scale ranges:1 to 5, 1=best; 5=worst: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake \> mediastinum but ≤ liver; 4, uptake moderately \> liver; 5, uptake markedly higher than liver; X. CR=scores 1-3 on \& PR is calculated by measured change from baseline (score 4 or 5).

For this outcome only 1 out of the 2 participants in the GZL cohort had a PET scan at the time of best response. In the DLBCL cohort only 6 out of the 9 had a PET Scan at the time of best response.

→

secondary · POSTED

DOR is beginning at the date clinical response is first identified; measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is documented and will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Complete response is \<1 cm lymph nodes/lymph node masses, and normal bone marrow/physical exam (PE); unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease lymph node masses, normal PE and indeterminate in bone marrow; partial response is ≥50% decrease in lymph nodes/lymph node masses, decrease in liver/spleen and irrelevant in bone marrow; and progression is \>50% new or increased lymph node masses/lymph nodes, enlarging liver/spleen, and reappearance in bone marrow.

9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.

→

secondary · POSTED

PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. PFS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Disease relapse is decline in prognosis and progression \>50% increase in lymph node masses/lymph nodes, enlarging liver/spleen, new sites and reappearance in bone marrow.

9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.

→

secondary · POSTED

EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first. EFS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Disease relapse is decline in prognosis and progression \>50% increase in lymph node masses/lymph nodes, enlarging liver/spleen, new sites and reappearance in bone marrow.

1 participant in the GZL cohort, and 1 participant enrolled in the DLBCL cohort 1 were not evaluable due to withdrawal of consent prior to treatment.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-primary-central-nervous-system-lymphoma
nct id
NCT03255018
trial label
Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0000
    source section id
    NCT03255018-om-0000
    source outcome index
    0
    endpoint
    Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
    endpoint definition
    Response was assessed by the International Working Group (IWG) response criteria which utilizes computed tomography (CT) scan to measure lymph node masses to assess response, bone marrow biopsies and aspirates done only if positive at the time of diagnosis or if clinically indicated. Response is calculated by measuring the sum of the products of all target lesions and then calculating the percent change from baseline or nadir. Products are calculated by multiplying the longest length by the perpendicular width of each target lesion. Confirmed complete response is \<1 cm lymph nodes/lymph node masses; unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease in size of lymph node masses; partial response is ≥50% decrease in size of lymph nodes/lymph node masses; and progression is \>50% new or increased lymph node masses/lymph nodes. Complete response (confirmed) followed by complete response(unconfirmed) and partial response are associated with better outcomes in that order.
    time origin
    Up to 24 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0001
    source section id
    NCT03255018-om-0001
    source outcome index
    1
    endpoint
    Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
    endpoint definition
    Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
    time origin
    Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy, approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    9/10 participants are analyzed in the DLBCL cohort because 1 participant enrolled in the DLBCL cohort was not evaluable due to withdrawal of consent prior to treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0002
    source section id
    NCT03255018-om-0002
    source outcome index
    2
    endpoint
    Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans
    endpoint definition
    The response rate is calculated by dividing the number of participants that had a complete response (CR) or partial response (PR) to therapy measured on positron emission tomography (PET) scan in accordance with the 5-point Lugano classification. Best overall response is the best response (complete or partial response) recorded from the start of the treatment until disease progression/recurrence. The 5-Point Scale Deauville criteria scores the most intense uptake in a site of initial disease: no uptake or no residual uptake, slight uptake, but above blood pool, uptake above mediastinal but below or =to uptake in liver, uptake slightly to moderately higher than liver, \& markedly increased uptake. 5Point Scale ranges:1 to 5, 1=best; 5=worst: 1, no uptake above background; 2, uptake ≤ mediastinum; 3, uptake \> mediastinum but ≤ liver; 4, uptake moderately \> liver; 5, uptake markedly higher than liver; X. CR=scores 1-3 on \& PR is calculated by measured change from baseline (score 4 or 5).
    time origin
    every 3-6 months for 24 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    For this outcome only 1 out of the 2 participants in the GZL cohort had a PET scan at the time of best response. In the DLBCL cohort only 6 out of the 9 had a PET Scan at the time of best response.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0003
    source section id
    NCT03255018-om-0003
    source outcome index
    3
    endpoint
    Duration of Response for Participants Who Respond to Pembrolizumab
    endpoint definition
    DOR is beginning at the date clinical response is first identified; measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is documented and will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Complete response is \<1 cm lymph nodes/lymph node masses, and normal bone marrow/physical exam (PE); unconfirmed complete response is \>1 cm lymph nodes and \>75% decrease lymph node masses, normal PE and indeterminate in bone marrow; partial response is ≥50% decrease in lymph nodes/lymph node masses, decrease in liver/spleen and irrelevant in bone marrow; and progression is \>50% new or increased lymph node masses/lymph nodes, enlarging liver/spleen, and reappearance in bone marrow.
    time origin
    every 3-6 months for 24 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0004
    source section id
    NCT03255018-om-0004
    source outcome index
    4
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. PFS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Disease relapse is decline in prognosis and progression \>50% increase in lymph node masses/lymph nodes, enlarging liver/spleen, new sites and reappearance in bone marrow.
    time origin
    up to 2 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0005
    source section id
    NCT03255018-om-0005
    source outcome index
    5
    endpoint
    Event-free Survival (EFS)
    endpoint definition
    EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first. EFS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. Response was assessed by the International Working Group response criteria (Cheson et al.). Disease relapse is decline in prognosis and progression \>50% increase in lymph node masses/lymph nodes, enlarging liver/spleen, new sites and reappearance in bone marrow.
    time origin
    up to 2 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    1 participant in the GZL cohort, and 1 participant enrolled in the DLBCL cohort 1 were not evaluable due to withdrawal of consent prior to treatment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Cohort 1 Gray-Zone Lymphoma (GZL)
    regimen
    Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
    regimen
    Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Cohort 1 Gray-Zone Lymphoma (GZL)
    regimen
    Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
    regimen
    Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Cohort 1 Gray-Zone Lymphoma (GZL)
    regimen
    Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
    regimen
    Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Cohort 1 Gray-Zone Lymphoma (GZL)
    regimen
    Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
    regimen
    Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Cohort 1 Gray-Zone Lymphoma (GZL)
    regimen
    Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
    regimen
    Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Cohort 1 Gray-Zone Lymphoma (GZL)
    regimen
    Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
    regimen
    Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03255018-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    harm key
    EG000
    source section id
    NCT03255018-ae
    event group key
    EG000
    event group label
    Cohort 1 Gray-Zone Lymphoma (GZL)
    serious affected
    0
    serious at risk
    2
    other affected
    2
    other at risk
    2
    frequency threshold
    0
    collection period
    Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-primary-central-nervous-system-lymphoma
    nct id
    NCT03255018
    harm key
    EG001
    source section id
    NCT03255018-ae
    event group key
    EG001
    event group label
    Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
    serious affected
    5
    serious at risk
    9
    other affected
    9
    other at risk
    9
    frequency threshold
    0
    collection period
    Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy., approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
    setting source links

      Preserved source evidence · Not medical advice