A Trial of Pembrolizumab (MK-3475) in Participants With B... | NCT01953692 | Trialant
NCT01953692
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Aug 4, 2021Actual
Enrollment
197Actual
Phase
Phase 1
Conditions
Myelodysplastic Syndrome
Multiple Myeloma
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma
Primary Mediastinal B-Cell Lymphoma
Interventions
Pembrolizumab
Lenalidomide 20 mg
Lenalidomide 25 mg
Countries
Not provided
Protocol Section
Identification Module
NCT ID
NCT01953692
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
3475-013
Secondary IDs
ID
Type
Description
Link
2013-001603-37
EudraCT Number
MK-3475-013
Other Identifier
Merck
Brief Title
A Trial of Pembrolizumab (MK-3475) in Participants With Blood Cancers (MK-3475-013/KEYNOTE-013)
Official Title
A Phase Ib Multi-Cohort Trial of MK-3475 (Pembrolizumab) in Subjects With Hematologic Malignancies
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Jul 2021
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 22, 2013Actual
Primary Completion Date
Jun 26, 2020Actual
Completion Date
Jun 26, 2020Actual
First Submitted Date
Sep 26, 2013
First Submission Date that Met QC Criteria
Sep 26, 2013
First Posted Date
Oct 1, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 15, 2021
Results First Submitted that Met QC Criteria
Jun 15, 2021
Results First Posted Date
Jul 12, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 2, 2021
Last Update Posted Date
Aug 4, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Merck Sharp & Dohme LLCINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this trial is to evaluate the safety, tolerability, and efficacy of pembrolizumab (MK-3475, KEYTRUDA®) and pembrolizumab in combination with lenalidomide (Cohort 5 only) in hematologic malignancies. The primary study hypotheses are that treatment with pembrolizumab will result in a clinically meaningful improvement in Objective Response Rate (ORR) or Complete Remission Rate (CRR).
The study includes an initial dose determination to establish the recommended phase 2 dose (RP2D) of lenalidomide given in combination with pembrolizumab in Cohort 5.
With Protocol Amendment 08, enrollment in the Multiple Myeloma arm (Cohort 2) has been completed and no further enrollment will be allowed and enrollment in the Non-Hodgkin Lymphoma Diffuse Large B Cell Lymphoma arm (Cohort 5) has been discontinued and no further enrollment will be allowed.
Detailed Description
Not provided
Conditions Module
Conditions
Myelodysplastic Syndrome
Multiple Myeloma
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Follicular Lymphoma
Primary Mediastinal B-Cell Lymphoma
Keywords
PD1
PD-1
PDL1
PD-L1
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
197Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Myelodysplastic Syndrome (MDS)
Experimental
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Biological: Pembrolizumab
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Experimental
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Number of Participants Who Experienced One or More Adverse Events (AEs):
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
Up to approximately 78.5 months
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Cohort 1: Myelodysplastic Syndrome (MDS)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. Cohort 1 was evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 10% using a binomial exact test. The percentage of participants with CR and PR as assessed by the investigator is presented.
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. The percentage of participants who experience ORR as assessed by the investigator is presented.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion criteria:
Has confirmed diagnosis of relapse or refractory Multiple Myeloma (enrollment completed), Primary mediastinal Large B cell Lymphoma, non-Hodgkin lymphoma (NHL), Follicular Lymphoma, Diffuse Large B cell lymphoma (enrollment discontinued), Hodgkin lymphoma or Myelodysplastic syndrome (enrollment completed).
Has measurable disease
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
Demonstrates adequate organ function
Prior therapy criteria must be met
Female participants of childbearing potential and male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
Exclusion Criteria:
Is currently participating in and receiving study therapy or has participated in a study of an investigational agent or used an investigational device within 4 weeks of the first dose of study therapy
Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years, has received a live vaccine within 30 days of planned start of study therapy, has received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1, received a monoclonal antibody within 4 weeks prior to study Day 1 or has not recovered from adverse events due to a previously administered agent
Has known clinically active central nervous system (CNS) involvement
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Has evidence of interstitial lung disease, active non-infectious pneumonitis, a known additional malignancy that is progressing or requires active treatment, an active infection requiring intravenous systemic therapy, an active autoimmune disease that has required systemic therapy, a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study starting with the pre-screening or screening visit through 120 days after the last dose of study therapy
Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways)
Has known symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
4B: Non-PMBCL + programmed cell death ligand 1 positive. DLBCL and FL were included in 4C and 4D. The remaining diseases in 4B were classified as "Other"
4C: follicular lymphoma (FL)
4D: diffuse large B-cell lymphoma (DLBCL) And C5: DLBCL
Recruitment Details
The study included an initial dose determination for Cohort 5 to determine the recommended Phase 2 dose (RP2D) of lenalidomide. Participants started at a dose of 25 mg. The RP2D dose was set at 20 mg and subsequent participants were enrolled at that dose.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
FG001
Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Apr 16, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Australia
Canada
France
Italy
United States
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Biological: Pembrolizumab
Cohort 4C: R/R Follicular Lymphoma (FL)
Experimental
Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Biological: Pembrolizumab
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Experimental
Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles.
Participants received pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. Cohort 2 was evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 25% using a binomial exact test. The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented.
CRR was defined as the percentage of participants with complete remission according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. Complete remission was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. Cohort 3 was evaluated statistically by comparing the complete remission for pembrolizumab to a fixed efficacy target of 10% using a binomial exact test. The percentage of participants with complete remission as assessed by the investigator is presented.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. The pooled Cohort 4 sub-cohorts were evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 25% using a binomial exact test. The percentage of participants with CR and PR as assessed by the investigator is presented.
Up to approximately 78.5 months
Objective Response Rate (ORR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
ORR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. Per protocol, Cohorts 4A, 4B, 4C, and 4D were not planned to be compared to an efficacy target. The percentage of participants with CR and PR as assessed by the investigator is presented.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. Per protocol, pooled Cohort 5 was not planned to be evaluated statistically compared to a fixed efficacy target. The percentage of participants with CR and PR as assessed by the investigator is presented.
Up to approximately 78.5 months
Up to approximately 78.5 months
Overall Survival (OS)
OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Up to approximately 78.5 months
Overall Survival (OS) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Up to approximately 78.5 months
Overall Survival (OS) in Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
Up to approximately 78.5 months
Duration of Response (DOR) in Cohort 1: Myelodysplastic Syndrome (MDS)
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. DOR as assessed by the investigator is presented.
Up to approximately 78.5 months
Duration of Response (DOR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
For participants who demonstrated a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), DOR was defined as the time from sCR, CR, VGPR, or PR to documented disease progression or death. Response was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. DOR as assessed by the investigator is presented.
Up to approximately 78.5 months
Duration of Response (DOR) in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
Up to approximately 78.5 months
Duration of Response (DOR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
Up to approximately 78.5 months
Duration of Response (DOR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
DOR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
Up to approximately 78.5 months
Duration of Response (DOR) in Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants in Cohort 1: Myelodysplastic Syndrome (MDS)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in Cohort 1: Myelodysplastic Syndrome (MDS)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants in Cohort 1: Myelodysplastic Syndrome (MDS)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
ORR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
ORR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
ORR was evaluated for each of Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide): Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and for nodal masses. PR was >50% decrease in the sum of product diameters for ≤6 target dominant masses for lymph nodes, spleen nodules, and liver nodules and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide): Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and for nodal masses. PR was >50% decrease in the sum of product diameters for ≤6 target dominant masses for lymph nodes, spleen nodules, and liver nodules and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
Up to approximately 78.5 months
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide): Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and for nodal masses. PR was >50% decrease in the sum of product diameters for ≤6 target dominant masses for lymph nodes, spleen nodules, and liver nodules and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. PD was defined as ≥1 of the following: increase of ≥25% from baseline of serum or urine M-component or >10 mg/dl difference between involved and uninvolved free light chain levels; development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; or hypercalcemia. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, >50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a >50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; >50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
Up to approximately 78.5 months
Progression-free Survival (PFS) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, >50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a >50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; >50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
Up to approximately 78.5 months
Progression-free Survival (PFS) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, >50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a >50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; >50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
Up to approximately 78.5 months
Progression-free Survival (PFS) in Participants Pooled From the Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, >50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a >50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; >50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
Up to approximately 78.5 months
Marrow Complete Response (mCR) in Cohort 1: Myelodysplastic Syndrome (MDS)
mCR was defined as ≤5% myeloblasts in the bone marrow with a decrease in myeloblasts ≥50% over pretreatment according to the modified International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. The percentage of participants with mCR as assessed by the investigator is presented.
Up to approximately 78.5 months
Cytogenic Complete Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Cytogenic complete response was evaluated by detection of chromosomal abnormalities by cytogenic techniques and assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Cytogenic complete response was defined as the disappearance of the chromosomal abnormality detected pre-treatment without the appearance of new chromosomal abnormalities. The percentage of participants with cytogenic complete response as assessed by the investigator is presented.
Up to approximately 78.5 months
Cytogenic Partial Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Cytogenic partial response was evaluated by detection of chromosomal abnormalities by cytogenic techniques and assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Cytogenic partial response was defined as ≥50% reduction of the chromosomal abnormality detected pre-treatment. The percentage of participants with cytogenic partial response as assessed by the investigator is presented.
Up to approximately 78.5 months
Erythroid Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Erythroid response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Erythroid response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criteria for an erythroid response include: hemoglobin (Hgb) increase by ≥1.5 grams/deciliter (g/dl) from pretreatment or reduction of ≥4 transfusions/8 weeks compared with the pre-treatment transfusion number in the previous 8 weeks. Only transfusions given for a Hgb of ≤9.0 g/dl pretreatment counted for response evaluation. The percentage of participants with an erythroid response as assessed by the investigator is presented.
Up to approximately 78.5 months
Neutrophil Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Neutrophil response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Neutrophil response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criterion for a neutrophil response was a ≥100% increase in neutrophil count from pre-treatment and an absolute increase of >0.5 x 10^9/Liter. The percentage of participants with a neutrophil response as assessed by the investigator is presented.
Up to approximately 78.5 months
Platelet Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Platelet response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Platelet response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criterion for a platelet response was an absolute increase of ≥30 x 10^9/Liter platelet count for participants with a pre-treatment count of ≥20 x 10^9/Liter and for participants with a pre-treatment count of <20 x 10^9/Liter there must have been an absolute increase to ≥20 x 10^9/Liter and a ≥100% increase in pre-treatment level. The percentage of participants with a platelet response as assessed by the investigator is presented.
Up to approximately 78.5 months
Time to Progression (TTP) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
TTP was defined as the time from first dose of study treatment to disease progression. Progressive disease was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. PD was defined as ≥1 of the following: increase of ≥25% from baseline of serum or urine M-component or >10 mg/dl difference between involved and uninvolved free light chain levels; development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; bone marrow plasma cell percentage absolute % must be ≥10%; or hypercalcemia. The TTP as assessed by the investigator is presented.
sCR was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. sCR was defined as complete response [CR] plus normal serum free light-chain ratio and absence of clonal cells in bone marrow. CR criteria are negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and ≤5% plasma cells in the bone marrow. The percentage of participants with sCR as assessed by the investigator is presented.
CR was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR was defined as negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and <5% plasmacytomas in the bone marrow. The percentage of participants with CR as assessed by the investigator is presented.
Up to approximately 78.5 months
Result
Ribrag V, Avigan DE, Green DJ, Wise-Draper T, Posada JG, Vij R, Zhu Y, Farooqui MZH, Marinello P, Siegel DS. Phase 1b trial of pembrolizumab monotherapy for relapsed/refractory multiple myeloma: KEYNOTE-013. Br J Haematol. 2019 Aug;186(3):e41-e44. doi: 10.1111/bjh.15888. Epub 2019 Apr 1. No abstract available.
Garcia-Manero G, Ribrag V, Zhang Y, Farooqui M, Marinello P, Smith BD. Pembrolizumab for myelodysplastic syndromes after failure of hypomethylating agents in the phase 1b KEYNOTE-013 study. Leuk Lymphoma. 2022 Jul;63(7):1660-1668. doi: 10.1080/10428194.2022.2034155. Epub 2022 Mar 4.
van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, Chain A, Lala M, Li M, Robey SH, Kondic AG, De Alwis D, Mayawala K, Jain L, Freshwater T. Immunogenicity of pembrolizumab in patients with advanced tumors. J Immunother Cancer. 2019 Aug 8;7(1):212. doi: 10.1186/s40425-019-0663-4.
Zinzani PL, Ribrag V, Moskowitz CH, Michot JM, Kuruvilla J, Balakumaran A, Zhang Y, Chlosta S, Shipp MA, Armand P. Safety and tolerability of pembrolizumab in patients with relapsed/refractory primary mediastinal large B-cell lymphoma. Blood. 2017 Jul 20;130(3):267-270. doi: 10.1182/blood-2016-12-758383. Epub 2017 May 10.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
FG00028 subjects
FG00130 subjects
FG00231 subjects
FG00321 subjects
FG0044 subjects
FG00522 subjects
FG00642 subjects
FG00713 subjects
FG0086 subjects
COMPLETED
FG0001 subjects
FG0015 subjects
FG00211 subjects
FG0037 subjects
FG0041 subjects
FG0054 subjects
FG00610 subjects
FG0073 subjects
FG0081 subjects
NOT COMPLETED
FG00027 subjects
FG00125 subjects
FG00220 subjects
FG00314 subjects
FG0043 subjects
FG00518 subjects
FG00632 subjects
FG00710 subjects
FG0085 subjects
Type
Comment
Reasons
Adverse Event
FG0005 subjects
FG0012 subjects
FG0024 subjects
FG0032 subjects
FG0041 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Clinical Progression
FG0000 subjects
FG00115 subjects
FG0027 subjects
FG0035 subjects
FG004
Death
FG0005 subjects
FG0010 subjects
FG0022 subjects
FG0032 subjects
FG004
Excluded Medication
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0023 subjects
FG0031 subjects
FG004
Physician Decision
FG00011 subjects
FG0014 subjects
FG0022 subjects
FG0032 subjects
FG004
Protocol Violation
FG0000 subjects
FG0012 subjects
FG0021 subjects
FG0030 subjects
FG004
Study for Cohort 5 Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0004 subjects
FG0012 subjects
FG0021 subjects
FG0032 subjects
FG004
All participants who received at least one dose of study treatment.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
BG001
Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00028
BG00130
BG00231
BG00321
BG0044
BG00522
BG00642
BG00713
BG0086
BG009197
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00071.4± 10.4
BG00167.9± 7.3
BG00234.4± 12.1
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG00113
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants Who Experienced One or More Adverse Events (AEs):
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
All participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
Units
Counts
Participants
OG00028
OG00130
OG00231
OG003
Title
Denominators
Categories
Title
Measurements
OG00027
OG00128
OG00231
OG003
Primary
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An adverse event was defined as any untoward medical occurrence in a participant administered study treatment and did not necessarily have a causal relationship with this treatment. An adverse event could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the study treatment was also an adverse event.
All participants who received at least 1 dose of study treatment.
Posted
Count of Participants
Participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Objective Response Rate (ORR) in Cohort 1: Myelodysplastic Syndrome (MDS)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. Cohort 1 was evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 10% using a binomial exact test. The percentage of participants with CR and PR as assessed by the investigator is presented.
All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Posted
Number
90% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. Cohort 2 was evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 25% using a binomial exact test. The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented.
All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
CRR was defined as the percentage of participants with complete remission according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. Complete remission was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. Cohort 3 was evaluated statistically by comparing the complete remission for pembrolizumab to a fixed efficacy target of 10% using a binomial exact test. The percentage of participants with complete remission as assessed by the investigator is presented.
All participants in Cohort 3 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
OG000
Primary
Objective Response Rate (ORR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. The pooled Cohort 4 sub-cohorts were evaluated statistically by comparing the ORR for pembrolizumab to a fixed efficacy target of 25% using a binomial exact test. The percentage of participants with CR and PR as assessed by the investigator is presented.
All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Posted
Number
90% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Primary
Objective Response Rate (ORR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
ORR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. Per protocol, Cohorts 4A, 4B, 4C, and 4D were not planned to be compared to an efficacy target. The percentage of participants with CR and PR as assessed by the investigator is presented.
All participants in Cohorts 4A, 4B, 4C, and 4D with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Primary
Objective Response Rate (ORR) in Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. Per protocol, pooled Cohort 5 was not planned to be evaluated statistically compared to a fixed efficacy target. The percentage of participants with CR and PR as assessed by the investigator is presented.
All participants pooled from Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Number
90% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. The percentage of participants who experience ORR as assessed by the investigator is presented.
All participants in Cohort 3 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
Secondary
Overall Survival (OS)
OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
All participants with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Posted
Median
95% Confidence Interval
Months
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
OG003
Secondary
Overall Survival (OS) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Posted
Median
95% Confidence Interval
Months
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
OG000
Secondary
Overall Survival (OS) in Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
OS was defined as the time from first dose of study treatment to death due to any cause. OS was calculated from product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the final analysis were censored at the date of the last follow-up.
All participants pooled from the Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Median
95% Confidence Interval
Months
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
Units
Counts
Participants
Secondary
Duration of Response (DOR) in Cohort 1: Myelodysplastic Syndrome (MDS)
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. DOR as assessed by the investigator is presented.
All participants in Cohort 1 with a baseline efficacy evaluation, at least 1 post-baseline efficacy evaluation, and who demonstrated a PR or CR. DOR was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 1.
Posted
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
Secondary
Duration of Response (DOR) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
For participants who demonstrated a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), DOR was defined as the time from sCR, CR, VGPR, or PR to documented disease progression or death. Response was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. DOR as assessed by the investigator is presented.
All participants in Cohort 2 with a baseline efficacy evaluation, at least 1 post-baseline efficacy evaluation, and who demonstrated a VGPR, PR, sCR, or CR. DOR was not analyzed because there were no participants who demonstrated a VGPR, PR, sCR, or CR in Cohort 2.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Secondary
Duration of Response (DOR) in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
All participants in Cohort 3 with a baseline efficacy evaluation, at least 1 post-baseline efficacy evaluation, and who demonstrated a PR or CR.
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
Secondary
Duration of Response (DOR) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation and who demonstrated a PR or CR. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Posted
Median
95% Confidence Interval
Months
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Secondary
Duration of Response (DOR) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
DOR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
All participants in Cohorts 4A, 4B, 4C, and 4D with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation and who demonstrated a PR or CR.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
OG001
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Secondary
Duration of Response (DOR) in Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
For participants who demonstrated a confirmed Complete Response (CR) or partial response (PR), DOR was defined as the time from CR or PR to documented disease progression or death. CR and PR were assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. DOR as assessed by the investigator is presented.
All participants pooled from the Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation and who demonstrated a PR or CR. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Median
95% Confidence Interval
Months
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants in Cohort 1: Myelodysplastic Syndrome (MDS)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
All participants in Cohort 1, who were PD-L1 positive, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. ORR by PD-L1 status was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 1.
Posted
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Units
Counts
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in Cohort 1: Myelodysplastic Syndrome (MDS)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
All participants in Cohort 1, who were PD-L1 negative, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. ORR by PD-L1 status was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 1.
Posted
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Units
Counts
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants in Cohort 1: Myelodysplastic Syndrome (MDS)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. CR was demonstrated by ≤5% myeloblasts with normal maturation of all cell lines in the bone marrow (persistent dysplasia will be noted) and normal findings for hemoglobin, platelet count, neutrophil count, and absence of blasts in the blood. PR was all CR criteria if abnormal before treatment except bone marrow blasts decreased by ≥50% over pre-treatment but still >5%. Cellularity and morphology are not relevant. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
All participants in Cohort 1, who had an indeterminate PD-L1 status, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. ORR by PD-L1 status was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 1.
Posted
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
All participants in Cohort 2, who were PD-L1 positive, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. ORR by PD-L1 status was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 2.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
All participants in Cohort 2, who were PD-L1 negative, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. ORR by PD-L1 status was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 2.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
ORR was defined as the percentage of the participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR=negative immunofixation of serum and urine+disappearance of soft tissue plasmacytomas+≤5% plasma cells in the bone marrow (BM); sCR=stringent complete response, CR as above+normal serum free light-chain ratio and absence of clonal cells in BM; VGPR=serum+urine M-protein (M-p) by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-p+urine M-p <100 mg/24 hr; PR=≥50% reduction of serum M-p+reduction in 24-hour urine M-p by ≥90% or to <200 mg/24 hours. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR, sCR, PR, VGPR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
All participants in Cohort 2, who had an indeterminate PD-L1 status, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. ORR by PD-L1 status was not analyzed because there were no participants who demonstrated a PR or CR in Cohort 2.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
All participants in Cohort 3, who were PD-L1 positive, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
All participants in Cohort 3, who were PD-L1 negative, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants in Cohort 3: Relapsed/Refractory (R/R) Hodgkin Lymphoma (HL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
All participants in Cohort 3, who had an indeterminate PD-L1 status, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Units
Counts
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D), who were PD-L1 positive, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D), who were PD-L1 negative, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D), who had an indeterminate PD-L1 status, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
ORR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
All participants in Cohorts 4A, 4B, 4C, and 4D, who were PD-L1 positive, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
ORR was evaluated for each of the Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
All participants in Cohorts 4A, 4B, 4C, and 4D, who were PD-L1 negative, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
ORR was evaluated for each of Cohort 4 sub-cohorts: 4A (primary mediastinal B-cell lymphoma), 4B (grey zone, splenic marginal zone, and mantle cell lymphomas), 4C (follicular lymphoma), and 4D (diffuse large B-Cell lymphoma). ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in bone marrow, spleen, liver, and lymph nodes. PR was >50% decrease in the sum of product diameters (SPD) for ≤6 target masses for lymph nodes and >50% decrease in SPD for a single nodule in greatest transverse diameter for spleen and liver, and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
All participants in Cohorts 4A, 4B, 4C, and 4D, who had an indeterminate PD-L1 status, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. ORR was not analyzed for Cohort 4B because there were no participants with a PD-L1 status of indeterminate in this Cohort.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Positive Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide): Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and for nodal masses. PR was >50% decrease in the sum of product diameters for ≤6 target dominant masses for lymph nodes, spleen nodules, and liver nodules and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 positive (PD-L1 of ≥1%) participants.
All participants pooled from Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide), who were PD-L1 positive, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Negative Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide): Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and for nodal masses. PR was >50% decrease in the sum of product diameters for ≤6 target dominant masses for lymph nodes, spleen nodules, and liver nodules and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for PD-L1 negative (PD-L1 of <1%) participants.
All participants pooled from Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide), who were PD-L1 negative, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
Secondary
Objective Response Rate (ORR) in Programmed Cell Death Ligand 1 (PD-L1) Indeterminate Participants Pooled From Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide): Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
ORR was defined as the percentage of participants with response (complete response [CR] or partial response [PR]) according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. CR was demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and for nodal masses. PR was >50% decrease in the sum of product diameters for ≤6 target dominant masses for lymph nodes, spleen nodules, and liver nodules and no size increase in the lymph nodes, spleen, or liver. PD-L1 was assessed by immunohistochemistry (IHC). The percentage of participants with CR and PR as assessed by the investigator is presented for participants with an indeterminate (missing) PD-L1 status.
All participants pooled from Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide), who had an indeterminate PD-L1 status, with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. PD was defined as ≥1 of the following: increase of ≥25% from baseline of serum or urine M-component or >10 mg/dl difference between involved and uninvolved free light chain levels; development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; or hypercalcemia. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, >50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a >50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; >50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
All participants in Cohort 3 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
Secondary
Progression-free Survival (PFS) in Participants Pooled From the Cohort 4 Non-Hodgkin Lymphoma (NHL) Sub-Cohorts (Cohorts 4A+4B+4C+4D)
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, >50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a >50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; >50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
All participants pooled from the Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of participants grouped by disease cohort (NHL).
Posted
Median
95% Confidence Interval
Months
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 4 Sub-cohorts (Cohorts 4A+4B+4C+4D)
Participants from the pooled Cohort 4 NHL sub-cohorts (Cohorts 4A+4B+4C+4D) received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Secondary
Progression-free Survival (PFS) in the Cohort 4 Non-Hodgkin Lymphoma (NHL) Individual Sub-Cohorts (Cohorts 4A, 4B, 4C, and 4D)
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, >50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a >50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; >50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
All participants in Cohorts 4A, 4B, 4C, and 4D with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
OG001
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Secondary
Progression-free Survival (PFS) in Participants Pooled From the Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide) Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
PFS was defined as the time from first dose of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. PD was assessed according to the revised response criteria for malignant lymphoma per Cheson et al. 2007. PD was the appearance of any new lesion, >50% increase in the sum of product diameters (SPD) of ≥1 lymph node, or a >50% increase in the longest diameter of a previous lymph node, lesions positron emission tomography (PET) positive if 18F-fluorodeoxyglucose (FDG)-avid lymphoma or PET positive prior to therapy for lymph nodes; >50% increase from nadir in the SPD of previous lesions in the liver and spleen; or new or recurrent involvement of the bone marrow. PFS was calculated from the Kaplan-Meier method for censored data. PFS as assessed by the investigator is presented.
All participants pooled from Cohort 5 (pembrolizumab + 20 or 25 mg doses of lenalidomide) with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation. The analysis was pre-specified to be a pooled analysis of all participants grouped by disease cohort (DLBCL) and treatment combination (irrespective of dose); therefore data by individual dose were not analyzed.
Posted
Median
95% Confidence Interval
Months
Up to approximately 78.5 months
ID
Title
Description
OG000
Pooled Cohort 5 (Pembrolizumab + 20 or 25 mg Doses of Lenalidomide)
Participants from the pooled Cohort 5 received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg or 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
Secondary
Marrow Complete Response (mCR) in Cohort 1: Myelodysplastic Syndrome (MDS)
mCR was defined as ≤5% myeloblasts in the bone marrow with a decrease in myeloblasts ≥50% over pretreatment according to the modified International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. The percentage of participants with mCR as assessed by the investigator is presented.
All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Posted
Number
90% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
OG000
Secondary
Cytogenic Complete Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Cytogenic complete response was evaluated by detection of chromosomal abnormalities by cytogenic techniques and assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Cytogenic complete response was defined as the disappearance of the chromosomal abnormality detected pre-treatment without the appearance of new chromosomal abnormalities. The percentage of participants with cytogenic complete response as assessed by the investigator is presented.
All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Posted
Number
90% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
OG000
Secondary
Cytogenic Partial Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Cytogenic partial response was evaluated by detection of chromosomal abnormalities by cytogenic techniques and assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Cytogenic partial response was defined as ≥50% reduction of the chromosomal abnormality detected pre-treatment. The percentage of participants with cytogenic partial response as assessed by the investigator is presented.
All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Posted
Number
90% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
OG000
Secondary
Erythroid Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Erythroid response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Erythroid response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criteria for an erythroid response include: hemoglobin (Hgb) increase by ≥1.5 grams/deciliter (g/dl) from pretreatment or reduction of ≥4 transfusions/8 weeks compared with the pre-treatment transfusion number in the previous 8 weeks. Only transfusions given for a Hgb of ≤9.0 g/dl pretreatment counted for response evaluation. The percentage of participants with an erythroid response as assessed by the investigator is presented.
All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Posted
Number
90% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
Secondary
Neutrophil Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Neutrophil response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Neutrophil response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criterion for a neutrophil response was a ≥100% increase in neutrophil count from pre-treatment and an absolute increase of >0.5 x 10^9/Liter. The percentage of participants with a neutrophil response as assessed by the investigator is presented.
All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Posted
Number
90% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
OG000
Secondary
Platelet Response in Cohort 1: Myelodysplastic Syndrome (MDS)
Platelet response was measured as an evaluation of hematologic improvement and was assessed according to the International Working Group (IWG) response criteria in myelodysplasia per Cheson et al. 2006. Platelet response baseline was based on an average of at least 2 pre-treatment measurements taken ≥1 week apart and not influenced by transfusions. Responses were considered significant if they lasted for ≥8 weeks. Criterion for a platelet response was an absolute increase of ≥30 x 10^9/Liter platelet count for participants with a pre-treatment count of ≥20 x 10^9/Liter and for participants with a pre-treatment count of <20 x 10^9/Liter there must have been an absolute increase to ≥20 x 10^9/Liter and a ≥100% increase in pre-treatment level. The percentage of participants with a platelet response as assessed by the investigator is presented.
All participants in Cohort 1 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Posted
Number
90% Confidence Interval
Percentage of participants
Up to approximately 78.5 months
ID
Title
Description
OG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
Secondary
Time to Progression (TTP) in Cohort 2: Relapsed Refractory/Refractory (rR/R) Multiple Myeloma (MM)
TTP was defined as the time from first dose of study treatment to disease progression. Progressive disease was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. PD was defined as ≥1 of the following: increase of ≥25% from baseline of serum or urine M-component or >10 mg/dl difference between involved and uninvolved free light chain levels; development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; bone marrow plasma cell percentage absolute % must be ≥10%; or hypercalcemia. The TTP as assessed by the investigator is presented.
All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
sCR was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. sCR was defined as complete response [CR] plus normal serum free light-chain ratio and absence of clonal cells in bone marrow. CR criteria are negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and ≤5% plasma cells in the bone marrow. The percentage of participants with sCR as assessed by the investigator is presented.
All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
CR was assessed according to the International Myeloma Working Group (IMWG) 2006 response criteria. CR was defined as negative immunofixation of serum and urine and disappearance of soft tissue plasmacytomas and <5% plasmacytomas in the bone marrow. The percentage of participants with CR as assessed by the investigator is presented.
All participants in Cohort 2 with a baseline efficacy evaluation and at least 1 post-baseline efficacy evaluation.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Units
Counts
Participants
OG000
Time Frame
Up to approximately 78.5 months
Description
The analysis population for adverse events (AEs) consisted of all participants who received ≥1 dose of study treatment. Per protocol, disease progression was not considered an 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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1: Myelodysplastic Syndrome (MDS)
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle
25
28
20
28
25
28
EG001
Cohort 2: Relapsed Refractory or Refractory(rR/R) Multiple Myeloma (MM)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles. The 25 mg dose of lenalidomide was the starting dose for dose determination.
4
6
1
6
5
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected31 at risk
EG0030 events0 affected21 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected22 at risk
EG0061 events1 affected42 at risk
EG0070 events0 affected13 at risk
EG0080 events0 affected6 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0009 events3 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pancytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Aortic valve disease
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events1 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Small intestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Axillary pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Acute graft versus host disease
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Bacteraemia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Bronchitis haemophilus
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Cholecystitis infective
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Enterococcal sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hepatitis E
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Lymph node abscess
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pneumonia fungal
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Sepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Septic shock
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Transfusion-related acute lung injury
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Meningioma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Haemorrhage intracranial
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Venoocclusive disease
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG00112 events11 affected30 at risk
EG0026 events6 affected31 at risk
EG0038 events5 affected21 at risk
EG0040 events0 affected4 at risk
EG0054 events4 affected22 at risk
EG00614 events10 affected42 at risk
EG0071 events1 affected13 at risk
EG0081 events1 affected6 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0014 events4 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Middle ear inflammation
Ear and labyrinth disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hyperthyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected28 at risk
EG0011 events1 affected30 at risk
EG0025 events5 affected31 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Conjunctival hyperaemia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Diplopia
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Miosis
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Vision blurred
Eye disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0027 events2 affected31 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected28 at risk
EG0011 events1 affected30 at risk
EG0024 events3 affected31 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Anal incontinence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected28 at risk
EG0013 events2 affected30 at risk
EG00211 events8 affected31 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0012 events2 affected30 at risk
EG00213 events11 affected31 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Gastrointestinal pain
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Haemorrhoidal haemorrhage
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected28 at risk
EG0015 events4 affected30 at risk
EG00211 events8 affected31 at risk
EG003
Salivary hypersecretion
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0011 events1 affected30 at risk
EG0026 events6 affected31 at risk
EG003
Asthenia
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG00111 events11 affected30 at risk
EG0029 events7 affected31 at risk
EG003
Catheter site related reaction
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Chest pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Chills
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0025 events3 affected31 at risk
EG003
Early satiety
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Fatigue
General disorders
MedDRA 23.0
Systematic Assessment
EG00013 events12 affected28 at risk
EG0012 events2 affected30 at risk
EG0027 events6 affected31 at risk
EG003
General physical health deterioration
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Malaise
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0025 events4 affected31 at risk
EG003
Oedema peripheral
General disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected28 at risk
EG0012 events2 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Pain
General disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Pyrexia
General disorders
MedDRA 23.0
Systematic Assessment
EG0006 events3 affected28 at risk
EG0012 events1 affected30 at risk
EG0025 events5 affected31 at risk
EG003
Swelling
General disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Thirst
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Xerosis
General disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0023 events3 affected31 at risk
EG003
Hepatocellular injury
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Contrast media allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Anal candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Anorectal infection bacterial
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0012 events2 affected30 at risk
EG0024 events2 affected31 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Cystitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Erysipelas
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Influenza
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0024 events3 affected31 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Oropharyngeal candidiasis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0024 events3 affected31 at risk
EG003
Pustule
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Rhinovirus infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected30 at risk
EG0024 events2 affected31 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected28 at risk
EG0013 events3 affected30 at risk
EG0024 events3 affected31 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0012 events2 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Subcutaneous haematoma
Injury, poisoning and procedural complications
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0026 events4 affected31 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Blood uric acid increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Serum ferritin increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Urine sodium decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Weight decreased
Investigations
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Weight increased
Investigations
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0023 events3 affected31 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected28 at risk
EG0016 events6 affected30 at risk
EG0025 events5 affected31 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0023 events2 affected31 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0013 events3 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected30 at risk
EG0025 events4 affected31 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Hyperphosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0024 events2 affected31 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypoalbuminaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0006 events4 affected28 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected28 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected28 at risk
EG0012 events1 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Hypophosphataemia
Metabolism and nutrition disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0024 events2 affected31 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected28 at risk
EG0012 events2 affected30 at risk
EG0024 events4 affected31 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0018 events8 affected30 at risk
EG0025 events4 affected31 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0012 events2 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0029 events8 affected31 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.0
Systematic Assessment
EG0005 events5 affected28 at risk
EG0011 events1 affected30 at risk
EG0024 events3 affected31 at risk
EG003
Tumour flare
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected28 at risk
EG0011 events1 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0012 events2 affected30 at risk
EG0025 events4 affected31 at risk
EG003
Hemiparesis
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Migraine
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Peripheral motor neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Peripheral sensorimotor neuropathy
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Restless legs syndrome
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Syncope
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Tremor
Nervous system disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Depression
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0011 events1 affected30 at risk
EG0023 events3 affected31 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0025 events5 affected31 at risk
EG003
Mental status changes
Psychiatric disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0024 events3 affected31 at risk
EG003
Pollakiuria
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0012 events2 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Urge incontinence
Renal and urinary disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Scrotal oedema
Reproductive system and breast disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0012 events2 affected30 at risk
EG00219 events12 affected31 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0007 events6 affected28 at risk
EG0012 events2 affected30 at risk
EG00211 events10 affected31 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0004 events3 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hypoxia
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0026 events5 affected31 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0023 events3 affected31 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0025 events3 affected31 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0023 events2 affected31 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0001 events1 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Livedo reticularis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0022 events2 affected31 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0004 events4 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pityriasis rosea
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events2 affected28 at risk
EG0013 events3 affected30 at risk
EG00210 events8 affected31 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0006 events6 affected28 at risk
EG0013 events3 affected30 at risk
EG0026 events6 affected31 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0003 events3 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Haematoma
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0021 events1 affected31 at risk
EG003
Hot flush
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0011 events1 affected30 at risk
EG0023 events2 affected31 at risk
EG003
Hypotension
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0002 events2 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Jugular vein thrombosis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Raynaud's phenomenon
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Thrombophlebitis
Vascular disorders
MedDRA 23.0
Systematic Assessment
EG0000 events0 affected28 at risk
EG0010 events0 affected30 at risk
EG0020 events0 affected31 at risk
EG003
Enrollment of participants into Cohort 5 of this study was discontinued after the Food and Drug Administration (FDA) implemented a clinical hold after determining the risks of pembrolizumab + lenalidomide outweighed any potential benefit.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 20 mg orally (PO) every day (QD) for 21 consecutive days with 7 days off within 28-day cycles. The 20 mg dose of lenalidomide is the RP2D.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle + lenalidomide 25 mg PO QD for 21 consecutive days with 7 days off within 28-day cycles.
Units
Counts
Participants
OG00028
OG00130
OG00231
OG00321
OG0044
OG00522
OG00642
OG00713
OG0086
Title
Denominators
Categories
Title
Measurements
OG0006
OG0012
OG0023
OG0031
OG0041
OG0053
OG0062
OG0070
OG0081
OG00027
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 10.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p > 0.10
exact binomial distribution
>0.9999
one-sided p value
Superiority
Units
Counts
Participants
OG00030
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.0 to 9.5)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p > 0.25
exact binomial distribution
>0.9999
one-sided p-value
Superiority
31
Title
Denominators
Categories
Title
Measurements
OG00022.6(11.1 to 38.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Comparison to a fixed efficacy target of 10%. H0: p ≤ 0.10 versus H1: p > 0.10
exact binomial distribution
0.0306
one-sided p-value
Superiority
Units
Counts
Participants
OG00086
Title
Denominators
Categories
Title
Measurements
OG00022.1(15.0 to 30.7)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Comparison to a fixed efficacy target of 25%. H0: p ≤ 0.25 versus H1: p > 0.25
exact binomial distribution
0.7696
one-sided p-value
Superiority
OG001
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
OG002
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
OG003
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle OR 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
OG004
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Participants received pembrolizumab 10 mg/kg by intravenous (IV) infusion on Day 1 of each 14-day cycle.
OG005
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
OG006
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00027
OG00130
OG00231
OG00321
OG0044
OG00520
OG00641
Title
Denominators
Categories
Title
Measurements
OG0006.0(3.5 to 12.2)
OG00120.2(14.1 to 35.5)
OG002NA(NA to NA)NA=Median OS and upper and lower limits not reached at time of data cut-off due to insufficient number of participants with an event.
OG00337.1(4.9 to NA)NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG00423.8(0.4 to 28.6)
OG005NA(14.7 to NA)NA=Median OS and upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG0064.9(3.6 to 7.8)
86
Title
Denominators
Categories
Title
Measurements
OG00012.0(6.0 to 22.5)
OG00018
Title
Denominators
Categories
Title
Measurements
OG00023.0(6.1 to NA)NA=OS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG0000
Units
Counts
Participants
OG0000
OG00020
Title
Denominators
Categories
Title
Measurements
OG00025.0(5.6 to NA)NA=DOR upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Title
Measurements
OG000NA(9.6 to NA)NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
OG002
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
OG003
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00010
OG0012
OG0022
OG0035
Title
Denominators
Categories
Title
Measurements
OG000NA(6.9 to NA)NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG001NA(1.7 to NA)NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG002NA(NA to NA)NA=Median DOR and upper and lower limits not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG00313.6(2.6 to NA)NA=DOR upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Units
Counts
Participants
OG0007
Title
Denominators
Categories
Title
Measurements
OG000NA(2.8 to NA)NA=Median DOR and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
Participants
OG0000
Participants
OG0000
Units
Counts
Participants
OG0000
Units
Counts
Participants
OG0000
Units
Counts
Participants
OG0000
Units
Counts
Participants
OG0000
OG00011
Title
Denominators
Categories
Title
Measurements
OG00054.5(23.4 to 83.3)
OG0002
Title
Denominators
Categories
Title
Measurements
OG00050.0(1.3 to 98.7)
Participants
OG00018
Title
Denominators
Categories
Title
Measurements
OG00072.2(46.5 to 90.3)
Units
Counts
Participants
OG00032
Title
Denominators
Categories
Title
Measurements
OG00018.8(7.2 to 36.4)
Units
Counts
Participants
OG00035
Title
Denominators
Categories
Title
Measurements
OG00011.4(3.2 to 26.7)
Units
Counts
Participants
OG00019
Title
Denominators
Categories
Title
Measurements
OG00047.4(24.4 to 71.1)
OG001
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
OG002
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
OG003
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00011
OG0012
OG0024
OG00315
Title
Denominators
Categories
Title
Measurements
OG00027.3(6.0 to 61.0)
OG001100.0(15.8 to 100.0)
OG0020.0(0.0 to 60.2)
OG0036.7(0.2 to 31.9)
OG001
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
OG002
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
OG003
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0004
OG0012
OG00214
OG00315
Title
Denominators
Categories
Title
Measurements
OG00075.0(19.4 to 99.4)
OG0010.0(0.0 to 84.2)
OG0027.1(0.2 to 33.9)
OG0030.0(0.0 to 21.8)
OG001
Cohort 4B: Other Non-Hodgkin Lymphoma: Grey Zone, Splenic Marginal Zone, and Mantle Cell Lymphomas
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
OG002
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
OG003
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0006
OG0010
OG0022
OG00311
Title
Denominators
Categories
Title
Measurements
OG00066.7(22.3 to 95.7)
OG00250.0(1.3 to 98.7)
OG00336.4(10.9 to 69.2)
Units
Counts
Participants
OG0004
Title
Denominators
Categories
Title
Measurements
OG00075.0(19.4 to 99.4)
Units
Counts
Participants
OG0008
Title
Denominators
Categories
Title
Measurements
OG00025.0(3.2 to 65.1)
Units
Counts
Participants
OG0006
Title
Denominators
Categories
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00030
Title
Denominators
Categories
Title
Measurements
OG0002.7(1.4 to 13.0)
OG00031
Title
Denominators
Categories
Title
Measurements
OG0008.7(4.9 to 28.1)
Units
Counts
Participants
OG00086
Title
Denominators
Categories
Title
Measurements
OG0001.7(1.4 to 2.7)
Participants received pembrolizumab 10 mg/kg by IV infusion on Day 1 of each 14-day cycle.
OG002
Cohort 4C: R/R Follicular Lymphoma (FL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
OG003
Cohort 4D: R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Participants received pembrolizumab 200 mg by IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00021
OG0014
OG00220
OG00341
Title
Denominators
Categories
Title
Measurements
OG00019.0(1.9 to NA)NA=PFS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.
OG0017.3(0.3 to 10.3)
OG0021.7(1.3 to 3.4)
OG0031.4(1.3 to 1.7)
Units
Counts
Participants
OG00018
Title
Denominators
Categories
Title
Measurements
OG0005.5(2.7 to NA)NA=PFS upper limit not reached at time of data cut-off due to insufficient number of participants with an event.