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Study of Lenalidomide and Dexamethasone With or Without Pembrolizumab (MK-3475) in Participants With Newly Diagnosed Treatment Naive Multiple Myeloma (MK-3475-185/KEYNOTE-185)

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ClinicalTrials.gov Identifier: NCT02579863
Recruitment Status : Active, not recruiting
First Posted : October 20, 2015
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Biological: Pembrolizumab
Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 310
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles. Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Period Title: Overall Study
Started 156 154
Treated 154 148
Completed 0 0
Not Completed 156 154
Reason Not Completed
Ongoing in Trial             105             112
Adverse Event             17             12
Death             11             3
Lost to Follow-up             2             1
Physician Decision             0             2
Screen Failure             1             2
Study Terminated at Selected Sites             3             3
Withdrawal by Subject             17             19
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone Total
Hide Arm/Group Description Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles. Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles. Total of all reporting groups
Overall Number of Baseline Participants 156 154 310
Hide Baseline Analysis Population Description
The analysis population included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 156 participants 154 participants 310 participants
74.4  (6.0) 74.3  (5.9) 74.4  (6.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 154 participants 310 participants
Female
85
  54.5%
81
  52.6%
166
  53.5%
Male
71
  45.5%
73
  47.4%
144
  46.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 154 participants 310 participants
Hispanic or Latino
4
   2.6%
4
   2.6%
8
   2.6%
Not Hispanic or Latino
143
  91.7%
136
  88.3%
279
  90.0%
Unknown or Not Reported
9
   5.8%
14
   9.1%
23
   7.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 156 participants 154 participants 310 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
27
  17.3%
27
  17.5%
54
  17.4%
Native Hawaiian or Other Pacific Islander
1
   0.6%
0
   0.0%
1
   0.3%
Black or African American
9
   5.8%
3
   1.9%
12
   3.9%
White
115
  73.7%
121
  78.6%
236
  76.1%
More than one race
1
   0.6%
0
   0.0%
1
   0.3%
Unknown or Not Reported
3
   1.9%
3
   1.9%
6
   1.9%
International Stage (I, II, III).   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 156 participants 154 participants 310 participants
Stage I 39 53 92
Stage II 70 66 136
Stage III 46 34 80
Missing 1 1 2
[1]
Measure Description:

The International Staging System (ISS) defines the factors that influence patient survival. The system has 3 stages based on the measurement of serum albumin and the levels of serum β2-microglobulin (β2-M).

Stage I: β2-M <3.5 mg/L with a serum albumin of 3.5 g/dL or more

Stage II: Either of these 2 criteria:

β2-M between 3.5 mg/L and 5.5 mg/dL Albumin <3.5 g/dL Stage III: β2-M >5.5 mg/L.

1.Primary Outcome
Title Progression Free Survival (PFS) Assessed by Clinical Adjudication Committee (CAC) Blinded Central Review According to the International Myeloma Working Group (IMWG) Response Criteria
Hide Description PFS was defined as the time from randomization to the first documented disease progression (events of new bone lesions, soft tissue plasmacytomas or an increase in existing lesions, or death due to any cause). The median PFS was calculated from the product-limit (Kaplan-Meier) method for censored data. The data cutoff date was July 9, 2018. Due to the smaller number of events, the tail of the estimated survival distribution was close to the median for both arms. The higher variability of the tail estimates resulted in observing the median estimate in the experimental arm but not in the standard of care arm even when number of events in 2 arms were similar. Additionally, since median of the experimental arm was in the tail of the estimated survival distribution, standard error of the survival estimates was missing before upper limit of the 95% confidence interval was reached, resulting in a missing upper limit of 95% confidence interval for the experimental arm.
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Overall Number of Participants Analyzed 156 154
Median (95% Confidence Interval)
Unit of Measure: Months
19.6 [1] 
(15.3 to NA)
NA [2] 
(15.5 to NA)
[1]
Upper Limit could not be estimated due to an insufficient number of events by the date of data cutoff.
[2]
The Median was not reached, and the Upper Limit could not be estimated due to insufficient number of events by the date of data cutoff.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pembrolizumab + Lenalidomide + Dexamethasone, Lenolidomide + Dexamethasone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36091
Comments [Not Specified]
Method Log Rank
Comments One-sided p-value based on Stratified log-rank test.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.57 to 1.47
Estimation Comments Based on Cox regression model with treatment as a covariate stratified by Age (<75 years vs >= 75 years) and ISS stage (I or II vs. III).
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up. The data cutoff date was July 9, 2018. This is an event-driven (events of death) outcome measure. At the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians).
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Overall Number of Participants Analyzed 156 154
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(27.3 to NA)
NA [2] 
(NA to NA)
[1]
The Median was not reached, and the Upper Limit could not be estimated due to insufficient number of events before the date of data cutoff.
[2]
The Median was not reached, and the Upper and Lower Limits could not be estimated due to insufficient number of events before the date of data cutoff.
3.Secondary Outcome
Title Overall Response Rate (ORR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review
Hide Description ORR was defined as the percentage of the participants in the analysis population who achieved at least a partial response (stringent complete response [sCR]+complete response [CR]+very good partial response [VGPR]+partial response [PR]) according to the IMWG. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The data cutoff date was July 9, 2018.
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Overall Number of Participants Analyzed 156 154
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
74.4
(66.8 to 81.0)
68.8
(60.9 to 76.0)
4.Secondary Outcome
Title Duration of Response (DOR) Evaluated According to IMWG Response Criteria by CAC Blinded Central Review
Hide Description Response duration was defined as the time from first documented evidence of at least a partial response (sCR+CR+VGPR+PR]), until confirmed disease progression or death. DOR was calculated from product-limit (Kaplan-Meier) method for censored data. The data cutoff date was July 9, 2018. This is an event-driven (events of disease progression and death) outcome measure. At the time of data cut-off, there were an insufficient number of events from the censored data to be able to estimate certain parameters (e.g. medians). Full Range is the minimum and maximum of the observed duration of response.
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants who demonstrated at least a partial response. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Overall Number of Participants Analyzed 116 106
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(14.5 to NA)
NA [1] 
(14.6 to NA)
[1]
The Median was not reached, and the Upper Limit could not be estimated due to insufficient number of events before the date of data cutoff.
5.Secondary Outcome
Title Disease Control Rate (DCR) Evaluated According to the IMWG Response Criteria by CAC Blinded Central Review
Hide Description Disease control rate was defined as the percentage of participants who achieved confirmed sCR, CR, VGPR, PR, or have demonstrated SD for at least 12 weeks prior to any evidence of progression. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours; SD = not meeting the criteria for CR, VGPR, PR, or PD; PD = development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. Data cutoff date was July 9, 2018.
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized.
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Overall Number of Participants Analyzed 156 154
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
91.0
(85.4 to 95.0)
91.6
(86.0 to 95.4)
6.Secondary Outcome
Title Second Progression Free Survival (PFS2)
Hide Description PFS2 was defined as the time from randomization to subsequent disease progression after initiation of new anti-cancer therapy, or death from any cause, whichever occurred first, by investigator assessment. PFS was assessed by Clinical Adjudication Committee (CAC) blinded central review according to the IMWG response criteria based on the development of new bone lesions or soft tissue plasmacytomas or on a definite increase in the size of existing bone lesions or soft tissue plasmacytomas. PFS2 was not completed due to incomplete enrollment for a clinical hold.
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population included all randomized participants. Participants were included in the treatment group to which they were randomized. PFS2 was not completed due to incomplete enrollment for a clinical hold.
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Number of Participants Who Experienced One or More Adverse Events (AEs)
Hide Description An AE was 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 was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received at least one dose of study treatment.
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Overall Number of Participants Analyzed 154 148
Measure Type: Count of Participants
Unit of Measure: Participants
152
  98.7%
141
  95.3%
8.Secondary Outcome
Title Number of Participants Discontinuing Study Treatment Due to an AE
Hide Description An AE was 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 was considered related to the medical treatment or procedure, that occurred during the course of the study.
Time Frame Up to approximately 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population consisted of all randomized participants who received at least one dose of study treatment.
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description:
Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
Overall Number of Participants Analyzed 154 148
Measure Type: Count of Participants
Unit of Measure: Participants
45
  29.2%
25
  16.9%
Time Frame Up to approximately 30 months
Adverse Event Reporting Description The analysis population consisted of all randomized participants who received at least one dose of study treatment. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Therefore, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.
 
Arm/Group Title Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Hide Arm/Group Description Participants received pembrolizumab 200 mg intravenously (IV) on Day 1 of each 21-day cycle PLUS lenalidomide 25 mg orally (PO) on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles. Participants received lenalidomide 25 mg PO on Days 1 to 21 of each 21-day treatment cycle, and dexamethasone 40 mg PO on Days 1, 8, 15 and 22 of each 28-day cycle for up to 18 cycles.
All-Cause Mortality
Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%)
Total   29/154 (18.83%)      17/148 (11.49%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   91/154 (59.09%)      65/148 (43.92%)    
Blood and lymphatic system disorders     
Anaemia  1  3/154 (1.95%)  3 5/148 (3.38%)  5
Cytopenia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Febrile neutropenia  1  3/154 (1.95%)  3 3/148 (2.03%)  3
Neutropenia  1  2/154 (1.30%)  3 0/148 (0.00%)  0
Thrombocytopenia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Angina pectoris  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Atrial fibrillation  1  4/154 (2.60%)  4 2/148 (1.35%)  2
Atrioventricular block complete  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Bradycardia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Cardiac arrest  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Cardiac failure  1  2/154 (1.30%)  2 2/148 (1.35%)  2
Cardiac failure acute  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Cardiac failure congestive  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Cardio-respiratory arrest  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Cardiopulmonary failure  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Myocardial infarction  1  0/154 (0.00%)  0 2/148 (1.35%)  2
Myocarditis  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Congenital, familial and genetic disorders     
Fanconi syndrome  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Hyperthyroidism  1  4/154 (2.60%)  4 0/148 (0.00%)  0
Hypothyroidism  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Inappropriate antidiuretic hormone secretion  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Secondary adrenocortical insufficiency  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Eye disorders     
Cataract  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Gastrointestinal disorders     
Colitis  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Colitis ischaemic  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Constipation  1  5/154 (3.25%)  6 0/148 (0.00%)  0
Diarrhoea  1  5/154 (3.25%)  5 1/148 (0.68%)  1
Dysphagia  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Gastrointestinal perforation  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Inguinal hernia strangulated  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Intestinal ischaemia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Ischaemic enteritis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Large intestine perforation  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Nausea  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Odynophagia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pancreatitis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pancreatitis acute  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Rectal haemorrhage  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Upper gastrointestinal haemorrhage  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Vomiting  1  1/154 (0.65%)  1 1/148 (0.68%)  1
General disorders     
Asthenia  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Chest pain  1  1/154 (0.65%)  1 3/148 (2.03%)  3
Death  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Hypothermia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Influenza like illness  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Malaise  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Oedema peripheral  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Pain  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pyrexia  1  8/154 (5.19%)  9 1/148 (0.68%)  1
Sudden death  1  1/154 (0.65%)  1 2/148 (1.35%)  2
Hepatobiliary disorders     
Cholecystitis acute  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Drug-induced liver injury  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Hepatic failure  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Hepatic function abnormal  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Hepatitis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Infections and infestations     
Abscess jaw  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Arthritis infective  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Bacteraemia  1  1/154 (0.65%)  2 0/148 (0.00%)  0
Bronchitis  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Bronchitis bacterial  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Cellulitis  1  2/154 (1.30%)  2 1/148 (0.68%)  1
Clostridium difficile colitis  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Diverticulitis  1  3/154 (1.95%)  4 0/148 (0.00%)  0
Fungaemia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Gastroenteritis  1  1/154 (0.65%)  2 0/148 (0.00%)  0
Influenza  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Klebsiella sepsis  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Lower respiratory tract infection  1  3/154 (1.95%)  4 1/148 (0.68%)  1
Lung infection  1  3/154 (1.95%)  3 0/148 (0.00%)  0
Neutropenic sepsis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Oesophageal candidiasis  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Osteomyelitis  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Peritonitis  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Pneumonia  1  13/154 (8.44%)  16 10/148 (6.76%)  10
Pneumonia cytomegaloviral  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pneumonia pneumococcal  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pneumonia respiratory syncytial viral  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Pulmonary sepsis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pulmonary tuberculosis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pyelonephritis  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Respiratory tract infection  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Sepsis  1  8/154 (5.19%)  8 4/148 (2.70%)  4
Septic shock  1  2/154 (1.30%)  2 2/148 (1.35%)  2
Sinusitis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Skin infection  1  1/154 (0.65%)  2 0/148 (0.00%)  0
Subcutaneous abscess  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Upper respiratory tract infection  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Urinary tract infection  1  2/154 (1.30%)  2 2/148 (1.35%)  2
Urosepsis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Injury, poisoning and procedural complications     
Accidental overdose  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Femoral neck fracture  1  0/154 (0.00%)  0 2/148 (1.35%)  2
Femur fracture  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Infusion related reaction  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pubis fracture  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Rib fracture  1  1/154 (0.65%)  1 2/148 (1.35%)  2
Spinal compression fracture  1  0/154 (0.00%)  0 3/148 (2.03%)  3
Spinal fracture  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Subdural haematoma  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Synovial rupture  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Investigations     
Blood bilirubin increased  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Blood creatinine increased  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Liver function test abnormal  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Neutrophil count decreased  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Transaminases increased  1  3/154 (1.95%)  3 0/148 (0.00%)  0
Troponin increased  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Metabolism and nutrition disorders     
Decreased appetite  1  2/154 (1.30%)  2 1/148 (0.68%)  1
Dehydration  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Electrolyte imbalance  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Fulminant type 1 diabetes mellitus  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Hypercalcaemia  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Hyperglycaemia  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Hyperkalaemia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Hypocalcaemia  1  2/154 (1.30%)  2 1/148 (0.68%)  1
Hypoglycaemia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Hypokalaemia  1  1/154 (0.65%)  1 2/148 (1.35%)  3
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/154 (0.65%)  1 3/148 (2.03%)  3
Back pain  1  3/154 (1.95%)  3 3/148 (2.03%)  3
Intervertebral disc protrusion  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Neck pain  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pain in extremity  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Rhabdomyolysis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Torticollis  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Pancreatic carcinoma  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Squamous cell carcinoma  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Tumour pain  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Nervous system disorders     
Aphasia  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Brain injury  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Dizziness  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Encephalopathy  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Epilepsy  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Headache  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Lethargy  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Myasthenia gravis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Peripheral motor neuropathy  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Presyncope  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Syncope  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Transient ischaemic attack  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Psychiatric disorders     
Anxiety  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Completed suicide  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Confusional state  1  0/154 (0.00%)  0 1/148 (0.68%)  2
Delirium  1  1/154 (0.65%)  1 1/148 (0.68%)  1
Psychotic disorder  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Suicide attempt  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Renal and urinary disorders     
Acute kidney injury  1  6/154 (3.90%)  6 2/148 (1.35%)  2
Renal failure  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Renal impairment  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Renal injury  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Urinary retention  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  2/154 (1.30%)  2 1/148 (0.68%)  1
Bronchitis chronic  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Chronic obstructive pulmonary disease  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Cough  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Dyspnoea  1  3/154 (1.95%)  4 2/148 (1.35%)  2
Epistaxis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Hypoxia  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Pneumonia aspiration  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Pneumonitis  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Pulmonary embolism  1  8/154 (5.19%)  8 0/148 (0.00%)  0
Pulmonary oedema  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Respiratory arrest  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Respiratory failure  1  0/154 (0.00%)  0 2/148 (1.35%)  2
Skin and subcutaneous tissue disorders     
Dermatitis exfoliative generalised  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Rash  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Rash erythematous  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Rash maculo-papular  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Skin ulcer  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Stevens-Johnson syndrome  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Vascular disorders     
Aortic aneurysm  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Deep vein thrombosis  1  2/154 (1.30%)  2 0/148 (0.00%)  0
Hypertension  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Hypertensive crisis  1  0/154 (0.00%)  0 1/148 (0.68%)  1
Hypotension  1  1/154 (0.65%)  1 3/148 (2.03%)  3
Orthostatic hypotension  1  1/154 (0.65%)  1 0/148 (0.00%)  0
Venous thrombosis limb  1  0/154 (0.00%)  0 1/148 (0.68%)  1
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pembrolizumab + Lenalidomide + Dexamethasone Lenolidomide + Dexamethasone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   143/154 (92.86%)      129/148 (87.16%)    
Blood and lymphatic system disorders     
Anaemia  1  32/154 (20.78%)  48 27/148 (18.24%)  40
Neutropenia  1  30/154 (19.48%)  54 26/148 (17.57%)  51
Thrombocytopenia  1  12/154 (7.79%)  16 12/148 (8.11%)  19
Endocrine disorders     
Hypothyroidism  1  12/154 (7.79%)  12 1/148 (0.68%)  1
Eye disorders     
Vision blurred  1  11/154 (7.14%)  12 3/148 (2.03%)  3
Gastrointestinal disorders     
Abdominal pain  1  13/154 (8.44%)  16 13/148 (8.78%)  19
Constipation  1  55/154 (35.71%)  62 33/148 (22.30%)  35
Diarrhoea  1  36/154 (23.38%)  51 34/148 (22.97%)  50
Dry mouth  1  12/154 (7.79%)  13 5/148 (3.38%)  5
Dyspepsia  1  8/154 (5.19%)  9 2/148 (1.35%)  2
Nausea  1  37/154 (24.03%)  54 33/148 (22.30%)  38
Stomatitis  1  9/154 (5.84%)  11 6/148 (4.05%)  6
Vomiting  1  30/154 (19.48%)  39 9/148 (6.08%)  16
General disorders     
Asthenia  1  13/154 (8.44%)  13 17/148 (11.49%)  20
Fatigue  1  44/154 (28.57%)  52 37/148 (25.00%)  39
Oedema  1  8/154 (5.19%)  8 6/148 (4.05%)  7
Oedema peripheral  1  25/154 (16.23%)  31 27/148 (18.24%)  28
Pyrexia  1  29/154 (18.83%)  41 10/148 (6.76%)  11
Infections and infestations     
Bronchitis  1  9/154 (5.84%)  12 4/148 (2.70%)  5
Nasopharyngitis  1  11/154 (7.14%)  16 11/148 (7.43%)  13
Oral candidiasis  1  15/154 (9.74%)  16 2/148 (1.35%)  2
Pneumonia  1  8/154 (5.19%)  8 2/148 (1.35%)  2
Upper respiratory tract infection  1  16/154 (10.39%)  16 13/148 (8.78%)  17
Urinary tract infection  1  15/154 (9.74%)  16 12/148 (8.11%)  16
Injury, poisoning and procedural complications     
Contusion  1  2/154 (1.30%)  3 8/148 (5.41%)  10
Fall  1  7/154 (4.55%)  10 9/148 (6.08%)  12
Investigations     
Alanine aminotransferase increased  1  11/154 (7.14%)  11 3/148 (2.03%)  3
Aspartate aminotransferase increased  1  8/154 (5.19%)  8 1/148 (0.68%)  1
Neutrophil count decreased  1  13/154 (8.44%)  24 12/148 (8.11%)  23
Weight decreased  1  10/154 (6.49%)  10 17/148 (11.49%)  18
Metabolism and nutrition disorders     
Decreased appetite  1  26/154 (16.88%)  28 19/148 (12.84%)  21
Dehydration  1  8/154 (5.19%)  14 5/148 (3.38%)  6
Gout  1  8/154 (5.19%)  14 4/148 (2.70%)  5
Hyperglycaemia  1  10/154 (6.49%)  17 8/148 (5.41%)  12
Hypocalcaemia  1  16/154 (10.39%)  18 8/148 (5.41%)  9
Hypokalaemia  1  26/154 (16.88%)  31 17/148 (11.49%)  21
Hypomagnesaemia  1  10/154 (6.49%)  10 5/148 (3.38%)  6
Hyponatraemia  1  9/154 (5.84%)  10 1/148 (0.68%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  17/154 (11.04%)  21 9/148 (6.08%)  12
Back pain  1  20/154 (12.99%)  24 17/148 (11.49%)  21
Muscle spasms  1  14/154 (9.09%)  17 14/148 (9.46%)  16
Muscular weakness  1  11/154 (7.14%)  13 4/148 (2.70%)  5
Musculoskeletal chest pain  1  11/154 (7.14%)  11 7/148 (4.73%)  7
Musculoskeletal pain  1  11/154 (7.14%)  14 10/148 (6.76%)  11
Pain in extremity  1  9/154 (5.84%)  11 8/148 (5.41%)  10
Nervous system disorders     
Dizziness  1  14/154 (9.09%)  15 14/148 (9.46%)  15
Dysgeusia  1  11/154 (7.14%)  11 15/148 (10.14%)  15
Headache  1  9/154 (5.84%)  9 11/148 (7.43%)  14
Neuropathy peripheral  1  9/154 (5.84%)  11 12/148 (8.11%)  13
Tremor  1  11/154 (7.14%)  11 16/148 (10.81%)  16
Psychiatric disorders     
Anxiety  1  12/154 (7.79%)  14 11/148 (7.43%)  12
Depression  1  9/154 (5.84%)  10 8/148 (5.41%)  8
Insomnia  1  22/154 (14.29%)  25 27/148 (18.24%)  33
Respiratory, thoracic and mediastinal disorders     
Cough  1  20/154 (12.99%)  21 18/148 (12.16%)  19
Dysphonia  1  3/154 (1.95%)  6 10/148 (6.76%)  10
Dyspnoea  1  19/154 (12.34%)  21 12/148 (8.11%)  12
Epistaxis  1  8/154 (5.19%)  8 6/148 (4.05%)  6
Oropharyngeal pain  1  8/154 (5.19%)  10 5/148 (3.38%)  5
Skin and subcutaneous tissue disorders     
Dry skin  1  9/154 (5.84%)  9 3/148 (2.03%)  3
Night sweats  1  8/154 (5.19%)  10 5/148 (3.38%)  5
Pruritus  1  13/154 (8.44%)  17 5/148 (3.38%)  5
Rash  1  31/154 (20.13%)  45 18/148 (12.16%)  19
Rash maculo-papular  1  14/154 (9.09%)  19 11/148 (7.43%)  13
Vascular disorders     
Hypotension  1  12/154 (7.79%)  13 8/148 (5.41%)  9
1
Term from vocabulary, MedDRA 21.0
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: NCT02579863     History of Changes
Other Study ID Numbers: 3475-185
2015-002901-12 ( EudraCT Number )
163239 ( Registry Identifier: JAPIC-CTI )
MK-3475-185 ( Other Identifier: Merck )
KEYNOTE-185 ( Other Identifier: Merck )
First Submitted: October 16, 2015
First Posted: October 20, 2015
Results First Submitted: June 7, 2019
Results First Posted: September 17, 2019
Last Update Posted: September 17, 2019