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)

• ClinicalTrials.gov Identifier: NCT02576990
• Recruitment Status: Completed
• First Posted: October 15, 2015
• Results First Posted: June 24, 2020
• Last Update Posted: July 27, 2023
• Sponsor: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Merck Sharp & Dohme LLC

• 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

Participant Flow

Recruitment Details
Pre-assignment Details	Of the 80 participants allocated in the study, 76 participants received at least one dose of study treatment.

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
Period Title: Overall Study
Started	56	24
Treated	53	23
Completed	0	0
Not Completed	56	24
Reason Not Completed
Death	29	18
Physician Decision	1	0
Screen failure	2	0
Sponsor's decision	24	4
Withdrawal by Subject	0	2

Baseline Characteristics

Arm/Group Title		Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)	Total
Arm/Group Description		Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Total of all reporting groups
Overall Number of Baseline Participants		56	24	80
Baseline Analysis Population Description		All allocated participants
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	56 participants	24 participants	80 participants
		35.0 (10.4)	67.2 (11.0)	44.7 (18.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	24 participants	80 participants
	Female	30 53.6%	7 29.2%	37 46.3%
	Male	26 46.4%	17 70.8%	43 53.8%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	24 participants	80 participants
	Hispanic or Latino	4 7.1%	1 4.2%	5 6.3%
	Not Hispanic or Latino	37 66.1%	21 87.5%	58 72.5%
	Unknown or Not Reported	15 26.8%	2 8.3%	17 21.3%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	56 participants	24 participants	80 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 1.8%	0 0.0%	1 1.3%
	White	51 91.1%	24 100.0%	75 93.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	4 7.1%	0 0.0%	4 5.0%

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate (ORR) Based on International Working Group (IWG) Response Assessment Criteria Per Independent Central Review
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 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.
Time Frame	Up to approximately 27 months (Database Cutoff: 28MAY2019)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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: Percentage 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
Description	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.
Time Frame	Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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
	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
Description	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.
Time Frame	Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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
Description	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.
Time Frame	Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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
Description	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.
Time Frame	Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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
Description	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.
Time Frame	Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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
Description	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.
Time Frame	Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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
Description	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.
Time Frame	Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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)
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)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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 Experienced an Adverse Event (AE)
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. The number of participants who experienced an AE were reported.
Time Frame	Up to approximately 30 months (Up to 90 days after last dose of study treatment) (Database Cutoff Date: 28MAY2019)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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
Description	An 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 discontinued study drug due to an AE were reported.
Time Frame	Up to approximately 27 months (Database Cutoff Date: 28MAY2019)

Outcome Measure Data

Analysis Population Description

The analysis population included all participants who received at least one dose of study medication (pembrolizumab).

Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)	Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description:	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).	Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week 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%

Adverse Events

Time Frame	Serious adverse events (AEs), non-serious AEs and all-cause mortality was collected up to approximately 56 months through end of trial (EOT) data cut-off date 23 Oct 2020.
Adverse Event Reporting Description	All-cause mortality was reported on all allocated participants. Serious and non-serious AEs were reported among participants who received at least one dose of study treatment. Per protocol, disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" unrelated to study drug were excluded.
Arm/Group Title	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)		Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
Arm/Group Description	Pembrolizumab 200 mg every 3 weeks (Q3W), intravenous infusion (IV) on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).		Pembrolizumab 200 mg Q3W, IV on Day 1 of each 3-week cycle for up to 35 administrations (approximately 2 years).
All-Cause Mortality
	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)		Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	30/56 (53.57%)		19/24 (79.17%)
Serious Adverse Events
	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)		Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
	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 23.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pembrolizumab: Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL)		Pembrolizumab: Relapsed or Refractory Richter Syndrome (rrRS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	46/53 (86.79%)		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	6/53 (11.32%)	7	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%)	6	1/23 (4.35%)	1
1 Term from vocabulary, MedDRA 23.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.
• Phone: 1-800-672-6372
• EMail: ClinicalTrialsDisclosure@merck.com

Publications of Results:

Armand P, Rodig S, Melnichenko V, Thieblemont C, Bouabdallah K, Tumyan G, Ozcan M, Portino S, Fogliatto L, Caballero MD, Walewski J, Gulbas Z, Ribrag V, Christian B, Perini GF, Salles G, Svoboda J, Zain J, Patel S, Chen PH, Ligon AH, Ouyang J, Neuberg D, Redd R, Chatterjee A, Balakumaran A, Orlowski R, Shipp M, Zinzani PL. Pembrolizumab in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma. J Clin Oncol. 2019 Dec 1;37(34):3291-3299. doi: 10.1200/JCO.19.01389. Epub 2019 Oct 14.

Armand P, Murawski N, Molin D, Zain J, Eichhorst B, Gulbas Z, Hawkes EA, Pagel JM, Phillips T, Ribrag V, Svoboda J, Stathis A, Chatterjee A, Orlowski R, Marinello P, Christian B. Pembrolizumab in relapsed or refractory Richter syndrome. Br J Haematol. 2020 Jul;190(2):e117-e120. doi: 10.1111/bjh.16762. Epub 2020 Jun 16. No abstract available.

Zinzani PL, Thieblemont C, Melnichenko V, Bouabdallah K, Walewski J, Majlis A, Fogliatto L, Garcia-Sancho AM, Christian B, Gulbas Z, Ozcan M, Perini GF, Ghesquieres H, Shipp MA, Thompson S, Chakraborty S, Marinello P, Armand P. Pembrolizumab in relapsed or refractory primary mediastinal large B-cell lymphoma: final analysis of KEYNOTE-170. Blood. 2023 Jul 13;142(2):141-145. doi: 10.1182/blood.2022019340.

• Responsible Party: Merck Sharp & Dohme LLC
• ClinicalTrials.gov Identifier: NCT02576990
• Other Study ID Numbers: 3475-170; MK-3475-170 ( Other Identifier: Merck ); KEYNOTE-170 ( Other Identifier: Merck ); 2015-002406-37 ( EudraCT Number )
• 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: July 27, 2023