Trial · NCT02576990
Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma or Relapsed or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170)
NCT02576990, Phase 2, Completed, Merck Sharp & Dohme LLC; results first posted 2020-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma or Relapsed or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170). Trials, record NCT02576990. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02576990
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Pembrolizumab (MK-3475) in Participants With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma or Relapsed or Refractory Richter Syndrome (MK-3475-170/KEYNOTE-170)
- NCT number
- NCT02576990
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 80 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Mediastinal Large B-cell Lymphoma, Richter Syndrome
- Interventions
- Pembrolizumab
- First posted
- 2015-10-15
- Last updated
- 2023-07-27
- Other registries' IDs
- eudract:2015-002406-37
- Results first posted
- 2020-06-24
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) Based on International Working Group (IWG) Response Assessment Criteria Per Independent Central Review | Up to approximately 27 months (Database Cutoff: 28MAY2019) | The ORR was assessed by independent central review utilizing the International Working Group \[IWG\] response assessment criteria per Cheson 2007 of pembrolizumab in participants with rrPMBCL. For participants with rrRS, IWG criteria with special considerations for RS was used for progression. The ORR was defined as the percentage of participants who had a response (complete response, CR or partial response, PR) prior to disease progression. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Participants with missing data were considered non-responders. In the rrPMBCL cohort, an exact binomial test was conducted versus a fixed historical control rate. For the rrPMBCL cohort, the ORR was estimated as well as a 95% 2-sided exact confidence interval (CI) using the Clopper-Pearson method whereas the rrRS cohort was estimated with a 90% 2-sided CI. |
| Secondary | ORR Based on IWG Response Assessment Criteria by Investigator Assessment | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The ORR was assessed by Investigator assessment utilizing the IWG response assessment criteria per Cheson 2007 of pembrolizumab in participants with rrPMBCL. For participants with rrRS, IWG criteria with special considerations for RS was used for progression. The ORR was defined as the percentage of participants who had a response (CR or PR) prior to disease progression. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Participants with missing data were considered non-responders. In the rrPMBCL cohort, an exact binomial test was conducted versus a fixed historical control rate. |
| Secondary | Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Independent Central Review | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | PFS was defined as the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD is the appearance of any new lesion or increase by ≥ 50% of previously involved site from nadir. Calculated from the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Investigator Assessment | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | PFS was defined as the time from the first dose to the first documented PD or death due to any cause, whichever occurs first. PD is the appearance of any new lesion or increase by ≥ 50% of previously involved site from nadir. Calculated from the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Duration of Response (DOR) Based on IWG Response Assessment Criteria by Independent Central Review in Participants With Responses | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The DOR was defined, only for the subgroup of participants who achieved a CR or PR by independent central review, as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. The analysis consisted of Kaplan-Meier estimates. DOR data was censored on the date of the last disease assessment documenting absence of PD for participants who did not have tumor progression and were still on study at the time of an analysis, were given antitumor treatment other than the study treatment, or were removed from study prior to documentation of tumor progression. |
| Secondary | Duration of Response (DOR) Based on IWG Response Assessment Criteria by Investigator Assessment in Participants With Responses | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The DOR was defined, only for the subgroup of participants who achieved a CR or PR by investigator assessment, as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. The analysis consisted of Kaplan-Meier estimates. DOR data was censored on the date of the last disease assessment documenting absence of PD for participants who did not have tumor progression and were still on study at the time of an analysis, were given antitumor treatment other than the study treatment, or were removed from study prior to documentation of tumor progression. |
| Secondary | Disease Control Rate (DCR) Based on IWG Response Assessment Criteria by Independent Central Review | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The DCR was defined as the percentage of participants in the analysis population who have achieved a CR, PR or stable disease (SD) response prior to PD. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. SD is the failure to attain CR/PR or PD. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. Participants with missing data were considered non-responders. |
| Secondary | Disease Control Rate (DCR) Based on IWG Response Assessment Criteria by Investigator Assessment | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The DCR was defined as the percentage of participants in the analysis population who have achieved a CR, PR or SD response prior to PD. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. SD is the failure to attain CR/PR or PD. PD is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. Participants with missing data were considered non-responders. |
| Secondary | Overall Survival (OS) | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | OS was defined as the time from the first dose to death due to any cause. OS is presented from product limit (Kaplan-Meier) method for censored data (censored at the last assessment). |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 30 months (Up to 90 days after last dose of study treatment) (Database Cutoff Date: 28MAY2019) | An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The number of participants who experienced an AE were reported. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) Based on International Working Group (IWG) Response Assessment Criteria Per Independent Central Review | Up to approximately 27 months (Database Cutoff: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab). | Percentage of participants | NUMBER |
| SECONDARY | ORR Based on IWG Response Assessment Criteria by Investigator Assessment | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab). | Percentage of participants | NUMBER |
| SECONDARY | Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Independent Central Review | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab). | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Investigator Assessment | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab). | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Based on IWG Response Assessment Criteria by Independent Central Review in Participants With Responses | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab) and who achieved a CR or PR by independent central review, as the time from start of the first documentation of objective tumor response (CR or PR). | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) Based on IWG Response Assessment Criteria by Investigator Assessment in Participants With Responses | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab) and who achieved a CR or PR by investigator assessment, as the time from start of the first documentation of objective tumor response (CR or PR). | Months | MEDIAN |
| SECONDARY | Disease Control Rate (DCR) Based on IWG Response Assessment Criteria by Independent Central Review | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab). | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) Based on IWG Response Assessment Criteria by Investigator Assessment | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab). | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | Up to approximately 27 months (Database Cutoff Date: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab). | Months | MEDIAN |
| SECONDARY | Number of Participants Who Experienced an Adverse Event (AE) | Up to approximately 30 months (Up to 90 days after last dose of study treatment) (Database Cutoff Date: 28MAY2019) | The analysis population included all participants who received at least one dose of study medication (pembrolizumab). | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) Based on International Working Group (IWG) Response Assessment Criteria Per Independent Central Review | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 45.3 | 95% Confidence Interval 31.6 to 59.6 | Percentage of participants | |
| Objective Response Rate (ORR) Based on International Working Group (IWG) Response Assessment Criteria Per Independent Central Review | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 13.0 | 95% Confidence Interval 3.7 to 30.4 | Percentage of participants | |
| ORR Based on IWG Response Assessment Criteria by Investigator Assessment | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 41.5 | 90% Confidence Interval 30.0 to 53.7 | Percentage of participants | |
| ORR Based on IWG Response Assessment Criteria by Investigator Assessment | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 4.3 | 90% Confidence Interval 0.2 to 19.0 | Percentage of participants | |
| Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Independent Central Review | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 5.5 | 95% Confidence Interval 2.8 to 15.1 | Months | |
| Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Independent Central Review | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 1.6 | 95% Confidence Interval 1.0 to 2.1 | Months | |
| Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Investigator Assessment | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 4.3 | 95% Confidence Interval 2.8 to 13.8 | Months | |
| Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Investigator Assessment | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 1.8 | 95% Confidence Interval 1.0 to 2.1 | Months | |
| Duration of Response (DOR) Based on IWG Response Assessment Criteria by Independent Central Review in Participants With Responses | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | NA | 95% Confidence Interval 25.2 to NA | Months | |
| Duration of Response (DOR) Based on IWG Response Assessment Criteria by Independent Central Review in Participants With Responses | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 4.5 | 95% Confidence Interval 2.7 to 6.2 | Months |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 56 | |
| Overall Study | STARTED | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 24 | |
| Overall Study | Treated | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 53 | |
| Overall Study | Treated | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 23 | |
| Overall Study | COMPLETED | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 0 | |
| Overall Study | COMPLETED | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 0 | |
| Overall Study | NOT COMPLETED | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 56 | |
| Overall Study | NOT COMPLETED | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 24 |
Source ClinicalTrials.gov
Adverse events180
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 | Anaemia | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 6 | 53 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 7 | 23 | 9 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 4 | 53 | 5 |
| other | Leukopenia | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 2 | 23 | 2 |
| other | Lymph node pain | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 0 | 53 | 0 |
| other | Lymph node pain | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 2 | 23 | 2 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 15 | 53 | 29 |
| other | Neutropenia | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 2 | 23 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 2 | 53 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 3 | 23 | 3 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 30 | 56 |
| Total, all-cause mortality | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 19 | 24 |
| Total, other adverse events | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 46 | 53 |
| Total, other adverse events | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 23 | 23 |
| Total, serious adverse events | Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) | 14 | 53 |
| Total, serious adverse events | Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS) | 15 | 23 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) vs Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS): deaths from any cause | Trial comparisons |
Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) vs Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS): Number of Participants Who Discontinued Study Drug Due to an AE | Trial comparisons |
Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) vs Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS): Number of Participants Who Experienced an Adverse Event (AE) | Trial comparisons |
| Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) vs Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS): 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.
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