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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576990
Recruitment Status : Active, not recruiting
First Posted : October 15, 2015
Results First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Mediastinal Large B-cell Lymphoma
Richter Syndrome
Intervention Biological: Pembrolizumab
Enrollment 80
Recruitment Details This study was conducted at 25 clinical centers in 13 countries.
Pre-assignment Details A screening period occurred 28 days prior to the treatment period. The treatment period consisted of a 28-day treatment cycle for up to 35 administrations of study medication (approximately 2 years). There was a post-treatment safety follow-up 30 days post the last dose of treatment. Survival was followed up every 12 weeks.
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years) Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Period Title: Overall Study
Started 56 24
Treated 53 23
Completed 13 0
Not Completed 43 24
Reason Not Completed
Physician Decision             3             1
Progressive Disease             17             12
Adverse Event             6             4
Complete Response             1             0
Withdrawal by Subject             0             2
Did not receive study treatment             3             1
Clinical Progression             13             4
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome Total
Hide Arm/Group Description Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years) Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years) Total of all reporting groups
Overall Number of Baseline Participants 53 23 76
Hide Baseline Analysis Population Description
The analysis population consisted of All Participants as Treated (APaT), i.e., all participants who received at least one dose of study medication (pembrolizumab).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 23 participants 76 participants
34.4  (9.8) 66.7  (11.0) 44.2  (18.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 23 participants 76 participants
Female
30
  56.6%
7
  30.4%
37
  48.7%
Male
23
  43.4%
16
  69.6%
39
  51.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 23 participants 76 participants
Hispanic or Latino
4
   7.5%
1
   4.3%
5
   6.6%
Not Hispanic or Latino
36
  67.9%
20
  87.0%
56
  73.7%
Unknown or Not Reported
13
  24.5%
2
   8.7%
15
  19.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 23 participants 76 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.9%
0
   0.0%
1
   1.3%
White
49
  92.5%
23
 100.0%
72
  94.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   5.7%
0
   0.0%
3
   3.9%
1.Primary Outcome
Title Objective Response Rate (ORR) Based on International Working Group (IWG) Response Assessment Criteria Per Independent Central Review
Hide Description 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 relapsed or refractory PMBCL. 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.
Time Frame Up to approximately 27 months (Database Cutoff: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 53 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percent of participants
45.3
(31.6 to 59.6)
13.0
(3.7 to 30.4)
2.Secondary Outcome
Title ORR Based on IWG Response Assessment Criteria by Investigator Assessment
Hide Description The ORR was assessed by Investigator assessment utilizing the International Working Group [IWG] response assessment criteria per Cheson 2007 of pembrolizumab in participants with relapsed or refractory PMBCL. 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.
Time Frame Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 53 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percent of participants
41.5
(30.0 to 53.7)
4.3
(0.2 to 19.0)
3.Secondary Outcome
Title Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Independent Central Review
Hide Description PFS is defined as the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Progressive disease 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. Data was censored at the last assessment for sensitivity analyses based on alternative censoring.
Time Frame Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 53 23
Median (95% Confidence Interval)
Unit of Measure: Months
5.5
(2.8 to 15.1)
1.6
(1.0 to 2.1)
4.Secondary Outcome
Title Progression Free Survival (PFS) Based on IWG Response Assessment Criteria by Investigator Assessment
Hide Description PFS is defined as the time from the first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Progressive disease 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.
Time Frame Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 53 23
Median (95% Confidence Interval)
Unit of Measure: Months
4.3
(2.8 to 13.8)
1.8
(1.0 to 2.1)
5.Secondary Outcome
Title Duration of Response (DOR) Based on IWG Response Assessment Criteria by Independent Central Review in Participants With Responses
Hide Description The DOR was defined, only for the subgroup of participants who achieved a complete response or partial response by independent central review, as the time from start of the first documentation of objective tumor response (complete response or partial response) to the first documentation of tumor progression 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. Progressive disease is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. The analysis consisted of Kaplan-Meier estimates. Duration of response 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.
Time Frame Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab) and who achieved a complete response or partial response by independent central review, as the time from start of the first documentation of objective tumor response (complete response or partial response).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 24 3
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(25.2 to NA)
4.5
(2.7 to 6.2)
[1]

NA = Median DOR was not reached (no progressive disease by time of last disease assessment).

NA = DOR upper limit was not reached (no progressive disease by time of last disease assessment).

6.Secondary Outcome
Title Duration of Response (DOR) Based on IWG Response Assessment Criteria by Investigator Assessment in Participants With Responses
Hide Description The DOR was defined, only for the subgroup of participants who achieved a complete response or partial response by investigator assessment, as the time from start of the first documentation of objective tumor response (complete response or partial response) to the first documentation of tumor progression 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. Progressive disease is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. The analysis consisted of Kaplan-Meier estimates. Duration of response 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.
Time Frame Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab) and who achieved a complete response or partial response by investigator assessment, as the time from start of the first documentation of objective tumor response (complete response or partial response).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 24 1
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(25.2 to NA)
NA [2] 
(NA to NA)
[1]

NA = Median DOR was not reached (no progressive disease by time of last disease assessment).

NA = DOR upper limit was not reached (no progressive disease by time of last disease assessment).

[2]

NA = Median DOR was not reached (no progressive disease by time of last disease assessment).

NA = DOR upper and lower limits were not reached (no progressive disease by time of last disease assessment).

7.Secondary Outcome
Title Disease Control Rate (DCR) Based on IWG Response Assessment Criteria by Independent Central Review
Hide Description The DCR, defined as the percentage of participants in the analysis population who have achieved a complete response, partial response or stable disease response 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. Stable disease is the failure to attain CR/PR or PD. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. Progressive disease is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. Participants with missing data were considered non-responders.
Time Frame Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 53 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
54.7
(42.6 to 66.5)
17.4
(6.2 to 35.5)
8.Secondary Outcome
Title Disease Control Rate (DCR) Based on IWG Response Assessment Criteria by Investigator Assessment
Hide Description The DCR, defined as the percentage of participants in the analysis population who have achieved a complete response, partial response or stable disease response 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. Stable disease is the failure to attain CR/PR or PD. Progressive disease is the appearance any new lesion or increase by ≥ 50% of previously involved site from nadir. Participants with missing data were considered non-responders.
Time Frame Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 53 23
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Percentage of participants
52.8
(40.7 to 64.7)
26.1
(12.0 to 45.1)
9.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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).
Time Frame Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 53 23
Median (95% Confidence Interval)
Unit of Measure: Months
22.3 [1] 
(7.3 to NA)
3.8
(1.8 to 18.1)
[1]
NA = OS upper limit was not reached (insufficient number of deaths by time of last disease assessment).
10.Secondary Outcome
Title Number of Participants Who Experience an Adverse Event (AE)
Hide Description 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.
Time Frame Up to approximately 30 months (Up to 90 days after last dose of study treatment) (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 53 23
Measure Type: Count of Participants
Unit of Measure: Participants
50
  94.3%
23
 100.0%
11.Secondary Outcome
Title Number of Participants Who Discontinued Study Drug Due to an AE
Hide Description 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.
Time Frame Up to approximately 27 months (Database Cutoff Date: 28MAY2019)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all participants who received at least one dose of study medication (pembrolizumab).
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description:
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
Overall Number of Participants Analyzed 53 23
Measure Type: Count of Participants
Unit of Measure: Participants
6
  11.3%
4
  17.4%
Time Frame Up to approximately 30 months (Up to 90 days after last dose of study treatment) (Database Cutoff: 28MAY2019)
Adverse Event Reporting Description All participants who received at least one dose of study medication (pembrolizumab). Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs, with the exception of drug-related deaths, which are reported as “Malignant Neoplasm Progression”.
 
Arm/Group Title Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Hide Arm/Group Description Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years) Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 28-day cycle for up to 35 administrations (approximately 2 years)
All-Cause Mortality
Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Affected / at Risk (%) Affected / at Risk (%)
Total   29/53 (54.72%)      17/23 (73.91%)    
Hide Serious Adverse Events
Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/53 (26.42%)      15/23 (65.22%)    
Blood and lymphatic system disorders     
Autoimmune haemolytic anaemia  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Febrile neutropenia  1  1/53 (1.89%)  1 3/23 (13.04%)  4
Neutropenia  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Thrombocytopenia  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Cardiac disorders     
Cardiac tamponade  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Myocardial infarction  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Pericardial effusion  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Pericarditis  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Supraventricular tachycardia  1  1/53 (1.89%)  2 0/23 (0.00%)  0
Tachycardia  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Endocrine disorders     
Hypercalcaemia of malignancy  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Hyperthyroidism  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Gastrointestinal disorders     
Diarrhoea  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Gastric perforation  1  1/53 (1.89%)  1 0/23 (0.00%)  0
General disorders     
Death  1  0/53 (0.00%)  0 1/23 (4.35%)  1
General physical health deterioration  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Pyrexia  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Infections and infestations     
Aspergillus infection  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Clostridium difficile infection  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Lower respiratory tract infection  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Pneumonia  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Sepsis  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Septic shock  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Staphylococcal infection  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Staphylococcal sepsis  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Injury, poisoning and procedural complications     
Subdural haematoma  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Investigations     
Aspartate aminotransferase increased  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Hepatic enzyme increased  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Metabolism and nutrition disorders     
Hypercalcaemia  1  0/53 (0.00%)  0 2/23 (8.70%)  2
Renal and urinary disorders     
Acute kidney injury  1  1/53 (1.89%)  1 1/23 (4.35%)  1
Urinary tract obstruction  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/53 (1.89%)  1 0/23 (0.00%)  0
Pleural effusion  1  1/53 (1.89%)  1 1/23 (4.35%)  1
Pneumonia aspiration  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Pneumonitis  1  1/53 (1.89%)  2 1/23 (4.35%)  1
Skin and subcutaneous tissue disorders     
Rash  1  0/53 (0.00%)  0 1/23 (4.35%)  2
Vascular disorders     
Hypotension  1  0/53 (0.00%)  0 1/23 (4.35%)  1
Venous thrombosis  1  1/53 (1.89%)  1 0/23 (0.00%)  0
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma Relapsed or Refractory Richter Syndrome
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/53 (84.91%)      23/23 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  6/53 (11.32%)  6 7/23 (30.43%)  9
Leukopenia  1  4/53 (7.55%)  5 2/23 (8.70%)  2
Lymph node pain  1  0/53 (0.00%)  0 2/23 (8.70%)  2
Neutropenia  1  15/53 (28.30%)  29 2/23 (8.70%)  2
Thrombocytopenia  1  2/53 (3.77%)  3 3/23 (13.04%)  3
Endocrine disorders     
Hypothyroidism  1  4/53 (7.55%)  4 2/23 (8.70%)  2
Gastrointestinal disorders     
Abdominal pain  1  5/53 (9.43%)  5 3/23 (13.04%)  3
Constipation  1  4/53 (7.55%)  4 3/23 (13.04%)  3
Diarrhoea  1  7/53 (13.21%)  9 5/23 (21.74%)  5
Nausea  1  6/53 (11.32%)  8 6/23 (26.09%)  7
Stomatitis  1  0/53 (0.00%)  0 2/23 (8.70%)  2
Vomiting  1  5/53 (9.43%)  5 2/23 (8.70%)  2
General disorders     
Asthenia  1  7/53 (13.21%)  10 2/23 (8.70%)  2
Chest pain  1  4/53 (7.55%)  4 0/23 (0.00%)  0
Chills  1  0/53 (0.00%)  0 3/23 (13.04%)  3
Fatigue  1  6/53 (11.32%)  7 8/23 (34.78%)  8
Pyrexia  1  15/53 (28.30%)  25 3/23 (13.04%)  4
Infections and infestations     
Bronchitis  1  3/53 (5.66%)  3 0/23 (0.00%)  0
Herpes zoster  1  3/53 (5.66%)  3 1/23 (4.35%)  1
Nasopharyngitis  1  8/53 (15.09%)  10 0/23 (0.00%)  0
Pharyngitis  1  3/53 (5.66%)  3 0/23 (0.00%)  0
Rhinitis  1  5/53 (9.43%)  6 0/23 (0.00%)  0
Upper respiratory tract infection  1  4/53 (7.55%)  5 0/23 (0.00%)  0
Urinary tract infection  1  1/53 (1.89%)  1 2/23 (8.70%)  2
Vulvovaginal mycotic infection  1  4/53 (7.55%)  5 0/23 (0.00%)  0
Investigations     
Aspartate aminotransferase increased  1  1/53 (1.89%)  2 2/23 (8.70%)  2
Blood alkaline phosphatase increased  1  1/53 (1.89%)  1 2/23 (8.70%)  2
Blood bilirubin increased  1  0/53 (0.00%)  0 2/23 (8.70%)  2
Blood creatinine increased  1  0/53 (0.00%)  0 3/23 (13.04%)  3
Metabolism and nutrition disorders     
Decreased appetite  1  2/53 (3.77%)  2 3/23 (13.04%)  3
Hyperglycaemia  1  4/53 (7.55%)  5 4/23 (17.39%)  4
Hyperkalaemia  1  0/53 (0.00%)  0 3/23 (13.04%)  3
Hypokalaemia  1  2/53 (3.77%)  2 2/23 (8.70%)  2
Hyponatraemia  1  2/53 (3.77%)  2 2/23 (8.70%)  2
Hypophosphataemia  1  1/53 (1.89%)  1 2/23 (8.70%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/53 (9.43%)  5 0/23 (0.00%)  0
Back pain  1  5/53 (9.43%)  5 2/23 (8.70%)  2
Myalgia  1  3/53 (5.66%)  4 0/23 (0.00%)  0
Pain in extremity  1  3/53 (5.66%)  3 1/23 (4.35%)  1
Nervous system disorders     
Dizziness  1  3/53 (5.66%)  3 0/23 (0.00%)  0
Headache  1  6/53 (11.32%)  11 1/23 (4.35%)  1
Hypoaesthesia  1  0/53 (0.00%)  0 2/23 (8.70%)  2
Neuropathy peripheral  1  1/53 (1.89%)  1 2/23 (8.70%)  2
Somnolence  1  2/53 (3.77%)  3 2/23 (8.70%)  2
Psychiatric disorders     
Insomnia  1  1/53 (1.89%)  1 2/23 (8.70%)  2
Respiratory, thoracic and mediastinal disorders     
Cough  1  10/53 (18.87%)  15 2/23 (8.70%)  2
Dyspnoea  1  10/53 (18.87%)  11 2/23 (8.70%)  2
Oropharyngeal pain  1  3/53 (5.66%)  4 0/23 (0.00%)  0
Productive cough  1  4/53 (7.55%)  4 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dry skin  1  3/53 (5.66%)  3 0/23 (0.00%)  0
Pruritus  1  4/53 (7.55%)  5 1/23 (4.35%)  1
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02576990    
Other Study ID Numbers: 3475-170
2015-002406-37 ( EudraCT Number )
MK-3475-170 ( Other Identifier: Merck Protocol Number )
KEYNOTE-170 ( Other Identifier: Merck )
First Submitted: October 14, 2015
First Posted: October 15, 2015
Results First Submitted: May 26, 2020
Results First Posted: June 24, 2020
Last Update Posted: June 24, 2020