Trial · NCT03255018
Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas
NCT03255018, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2023-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas. Trials, record NCT03255018. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03255018
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas
- NCT number
- NCT03255018
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Non-Hodgkin Lymphoma, Lymphoma, Diffuse Large B-Cell Lymphoma, Gray-zone Lymphoma, Primary Central Nervous System Lymphoma
- Interventions
- Pembrolizumab
- First posted
- 2017-08-21
- Last updated
- 2023-11-28
- Results first posted
- 2023-11-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Up to 24 months | 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. |
| Secondary | Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | 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. | 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. |
| Secondary | Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans | every 3-6 months for 24 months | 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). |
| Secondary | Duration of Response for Participants Who Respond to Pembrolizumab | every 3-6 months for 24 months | 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. |
| Secondary | Progression-free Survival (PFS) | up to 2 months | 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. |
| Secondary | Event-free Survival (EFS) | up to 2 months | 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. |
| Secondary | Overall Survival (OS) | every 3-6 months, up to 2.5 years | OS is the time from treatment start date until date of death from any cause, date last known alive or last follow up. OS will be estimated for each of the two types of lymphoma individually using Kaplan-Meier curves with appropriate confidence intervals reported. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | 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. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the participant or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Up to 24 months | 9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | 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. | 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. | adverse events | NUMBER |
| SECONDARY | Best Overall Response Rate According to the 5-point Lugano Classification for Interpreting 18 F-fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) Scans | every 3-6 months for 24 months | 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. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response for Participants Who Respond to Pembrolizumab | every 3-6 months for 24 months | 9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | up to 2 months | 9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment. | Months | MEDIAN |
| SECONDARY | Event-free Survival (EFS) | up to 2 months | 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. | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | every 3-6 months, up to 2.5 years | 9/10 participants are analyzed in the DLBCL cohort because 1 participant was not evaluable due to withdrawal of consent prior to treatment. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 1 Gray-Zone Lymphoma (GZL) | Complete Response | 50 | percentage of participants | |
| Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | Complete Response | 0 | percentage of participants | |
| Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 1 Gray-Zone Lymphoma (GZL) | Unconfirmed Complete Response | 0 | percentage of participants | |
| Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | Unconfirmed Complete Response | 0 | percentage of participants | |
| Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 1 Gray-Zone Lymphoma (GZL) | Partial Response | 0 | percentage of participants | |
| Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | Partial Response | 11 | percentage of participants | |
| Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 1 Gray-Zone Lymphoma (GZL) | Progressive Disease | 50 | percentage of participants | |
| Best Overall Response Rate of Pembrolizumab in Participants With Relapsed/Refractory Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | Progressive Disease | 89 | percentage of participants | |
| Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 1 Gray-Zone Lymphoma (GZL) | Grade 1 | 5 | adverse events | |
| Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL) | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | Grade 1 | 35 | adverse events |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 Gray-Zone Lymphoma (GZL) | 2 | |
| Overall Study | STARTED | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 10 | |
| Overall Study | COMPLETED | Cohort 1 Gray-Zone Lymphoma (GZL) | 2 | |
| Overall Study | COMPLETED | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 3 | |
| Overall Study | NOT COMPLETED | Cohort 1 Gray-Zone Lymphoma (GZL) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 7 |
Source ClinicalTrials.gov
Adverse events104
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Cohort 1 Gray-Zone Lymphoma (GZL) | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 1 | 9 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 Gray-Zone Lymphoma (GZL) | 1 | 2 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 2 | 9 | 2 |
| other | Alanine aminotransferase increased | Investigations | Cohort 1 Gray-Zone Lymphoma (GZL) | 1 | 2 | 2 |
| other | Alanine aminotransferase increased | Investigations | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 0 | 9 | 0 |
| other | Alkaline phosphatase increased | Investigations | Cohort 1 Gray-Zone Lymphoma (GZL) | 1 | 2 | 1 |
| other | Alkaline phosphatase increased | Investigations | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 0 | 9 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Cohort 1 Gray-Zone Lymphoma (GZL) | 0 | 2 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 1 | 9 | 1 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 Gray-Zone Lymphoma (GZL) | 0 | 2 |
| Total, all-cause mortality | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 5 | 9 |
| Total, other adverse events | Cohort 1 Gray-Zone Lymphoma (GZL) | 2 | 2 |
| Total, other adverse events | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 9 | 9 |
| Total, serious adverse events | Cohort 1 Gray-Zone Lymphoma (GZL) | 0 | 2 |
| Total, serious adverse events | Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL) | 5 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Cohort 1 Gray-Zone Lymphoma (GZL) vs Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL): Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). | Trial comparisons |
| Cohort 1 Gray-Zone Lymphoma (GZL) vs Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL): deaths from any cause | Trial comparisons |
| Cohort 1 Gray-Zone Lymphoma (GZL) vs Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03255018
GET https://conductscience.org/api/trials/v1/NCT03255018/results?page=2