A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relap... | NCT05005442 | Trialant
NCT05005442
Sponsor
Merck Sharp & Dohme LLC
Status
Completed
Last Update Posted
Feb 19, 2026Actual
Enrollment
192Actual
Phase
Phase 2
Conditions
Hematological Malignancies
Interventions
Pembrolizumab/vibostolimab coformulation
Countries
United States
Brazil
Canada
Chile
Denmark
France
Germany
Hungary
Israel
Italy
Poland
Russia
Spain
Taiwan
Turkey (Türkiye)
Ukraine
Protocol Section
Identification Module
NCT ID
NCT05005442
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7684A-004
Secondary IDs
ID
Type
Description
Link
MK-7684A-004
Other Identifier
MSD
KEYVIBE-004
Other Identifier
MSD
2021-001700-15
EudraCT Number
Brief Title
A Study of Pembrolizumab/Vibostolimab (MK-7684A) in Relapsed/Refractory Hematological Malignancies (MK-7684A-004, KEYVIBE-004)
Official Title
A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] With MK-3475 [Pembrolizumab] Coformulation) in Participants With Relapsed or Refractory Hematological Malignancies
Acronym
Not provided
Organization
Merck Sharp & Dohme LLCINDUSTRY
Status Module
Record Verification Date
Feb 2026
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
Sep 28, 2021Actual
Primary Completion Date
Dec 10, 2024Actual
Completion Date
Dec 10, 2024Actual
First Submitted Date
Aug 12, 2021
First Submission Date that Met QC Criteria
Aug 12, 2021
First Posted Date
Aug 13, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Nov 25, 2025
Results First Submitted that Met QC Criteria
Dec 16, 2025
Results First Posted Date
Dec 17, 2025Actual
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
Feb 17, 2026
Last Update Posted Date
Feb 19, 2026Actual
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 the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684).
Detailed Description
Not provided
Conditions Module
Conditions
Hematological Malignancies
Keywords
Not provided
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
192Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Pembrolizumab/vibostolimab coformulation
Experimental
Participants will receive pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Pembrolizumab 200 mg + vibostolimab 200 mg/20 mL vial IV infusion Q3W up to approximately 2 years.
Pembrolizumab/vibostolimab coformulation
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Dose-Limiting Toxicity (DLT)
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Percentage of participants who experience a DLT per CTCAE 5.0 are reported.
Up to approximately 6 weeks
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE is any unfavorable and unintended sign, 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 is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experience an AE are reported.
Up to approximately 27 months
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is any unfavorable and unintended sign, 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 is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants discontinued from the study treatment due to an AE are reported.
Up to approximately 24 months
Secondary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)
ORR for Cohorts A-D and F was assessed based on the Lugano 2014 Classification. ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). ORR for Cohorts A-D and F is presented. Cohort E is presented separately.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria
- Have confirmed relapsed/refractory classic Hodgkins Lymphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM).
For PMBCL, DLBCL, FL, and MM:
- Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it.
For DLBCL and NHL:
- Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease.
For NHL:
- Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy.
All participants:
Have measurable disease.
Have adequate organ function.
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation.
Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment.
Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle.
Exclusion Criteria
For DLBCL and NHL:
- Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (-like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms.
For MM:
Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance.
Has a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
Has known prior or current central nervous system (CNS) involvement.
For Epstein Barr virus (EBV) positive DLBCL:
- Associated with a solid organ transplant.
For all participants:
A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation.
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention.
Has a history of a second malignancy.
Any PMBCL participants that require the use of urgent cytoreductive therapy.
If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention.
Has received prior radiotherapy within 2 weeks of start of study intervention.
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.
Has a known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients.
Has a known history of Human Immunodeficiency Virus (HIV) infection.
Has an active autoimmune disease that has required systemic treatment in past 2 years.
Has an active infection requiring systemic therapy.
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment.
Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and Hepatitis C (HCV) infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry..
Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Medical Director
Merck Sharp & Dohme LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
City of Hope Comprehensive Cancer Center-Hematology ( Site 0024)
One hundred ninety-two participants were allocated, 1 participant was allocated but did not receive treatment due to worsening of underlying disease. No participants were enrolled into Part 2 of the study (The study was closed with amendment 5 after the last subject completed 35 cycles of the first course of Part 1).
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Dec 19, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group 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
MK7684A
Up to approximately 37 months
ORR as Assessed by the 2016 International Myeloma Working Group (IMWG) Response Criteria (Cohort E)
ORR for Cohort E was measured by 2016 IMWG Response Criteria. ORR is 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) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The ORR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.
Up to approximately 37 months
Duration of Response (DOR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)
For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)- CT and response was evaluated based on the Lugano 2014 Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR for Cohorts A-D and F are presented. Cohort E is presented separately.
Up to approximately 37 months
DOR as Assessed by 2016 IMWG Response Criteria (Cohort E)
DOR is defined as the time from CR or PR to documented disease progression or death. DOR for Cohort E was measured by the 2016 IMWG Response Criteria with response criteria defined as participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The DOR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.
Up to approximately 37 months
Disease Control Rate (DCR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)
DCR is % of participants who had tumor response per response criteria or have stable disease (SD) for ≥ 12 weeks before any evidence of progressive disease (PD). CR or PR were evaluated with CT and PET-CT. CR: complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. DCR for Cohorts A-D & F are presented. Cohort E is presented in a separate outcome measure.
Up to approximately 37 months
DCR as Assessed by 2016 IMWG Response Criteria (Cohort E)
DCR: percentage of participants who have achieved tumor response or have shown SD for at least 12 weeks before any evidence of PD per IMWG response criteria 2016. Response criteria are defined as participants with either a sCR, CR, VGPR, or PR. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. SD = Not meeting criteria for CR, VGPR, PR, or PD. PD as defined by prespecified 2016 IMWG response criteria. DCR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.
Up to approximately 37 months
Lowest Plasma Concentration (Ctrough) of Vibostolimab
Ctrough is the lowest concentration reached by a drug before the next dose is administered. Blood samples collected predose were used to determine Ctrough of Vibostolimab.
Predose at Cycles 1, 3, 7, 11, 15, 19, 23, 27 and 31. Cycle = 3 weeks
Maximum Concentration (Cmax) of Vibostolimab
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected post dose were used to determine Cmax of Vibostolimab.
Postdose: after end of infusion (up to ~10 minutes) at Cycles 1 and 8. Cycle = 3 weeks
University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0021
Aurora
Colorado
80045
United States
University of Chicago Medical Center ( Site 0005)
Chicago
Illinois
60637
United States
Henry Ford Hospital ( Site 0003)
Detroit
Michigan
48202
United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004)
Hackensack
New Jersey
07601
United States
Rutgers Cancer Institute of New Jersey ( Site 0023)
New Brunswick
New Jersey
08901
United States
University of Texas MD Anderson Cancer Center ( Site 0014)
Houston
Texas
77030
United States
Medical Oncology Associates, PS ( Site 0001)
Spokane
Washington
99208
United States
MEDICAL COLLEGE OF WISCONSIN ( Site 0016)
Milwaukee
Wisconsin
53226
United States
Instituto do Câncer e Transplante de Curitiba ( Site 0611)
Curitiba
Paraná
80510130
Brazil
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0601)
Natal
Rio Grande do Norte
59075-740
Brazil
BC Cancer Vancouver ( Site 0034)
Vancouver
British Columbia
V5Z 4E6
Canada
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0031)
Toronto
Ontario
m5g2m9
Canada
Jewish General Hospital ( Site 0032)
Montreal
Quebec
H3T 1E2
Canada
McGill University Health Centre ( Site 0037)
Montreal
Quebec
H4A 3J1
Canada
Instituto Nacional del Cancer ( Site 0626)
Chile
Region M. de Santiago
8380455
Chile
FALP-UIDO ( Site 0623)
Santiago
Region M. de Santiago
6900941
Chile
Rigshospitalet-Hematology - CTU ( Site 0361)
Copenhagen
Capital Region
2100
Denmark
Aarhus Universitetshospital, Skejby-Blodsygdomme ( Site 0362)
Aarhus
Central Jutland
8200
Denmark
Gustave Roussy-DITEP ( Site 0301)
Villejuif
Paris
94800
France
centre hospitalier lyon sud-Service Hématologie ( Site 0300)
Pierre-Bénite
Rhone
69310
France
Pitie Salpetriere University Hospital-Clinical haematology ( Site 0304)
Paris
75013
France
Universitätsklinikum Marburg ( Site 0333)
Marburg
Hesse
35033
Germany
Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0321)
Cologne
North Rhine-Westphalia
50937
Germany
Universitaetsklinikum Essen ( Site 0327)
Essen
North Rhine-Westphalia
45122
Germany
Klinikum Mutterhaus der Borromäerinnen-Innere Medizin I ( Site 0325)
Trier
Rhineland-Palatinate
54290
Germany
Universitätsklinikum Leipzig ( Site 0328)
Leipzig
Saxony
04103
Germany
Universitaetsklinikum Hamburg-Eppendorf-II. medical clinic ( Site 0332)
Hamburg
20246
Germany
Pécsi Tudományegyetem Klinikai Központ-I.sz. Belgyógyászati Klinika Hematológia ( Site 0401)
Pécs
Baranya
7624
Hungary
Országos Onkológiai Intézet-HEMATOLÓGIA ÉS LYMPHOMA OSZTÁLY KEMOTERÁPIA A ( Site 0405)
Budapest
Pest County
1122
Hungary
Semmelweis University-Belgyógyászati és Hematológiai Klinika ( Site 0403)
Budapest
1088
Hungary
Debreceni Egyetem Klinikai Kozpont-Belgyógyászati Klinika (Haematologia) ( Site 0402)
Debrecen
4032
Hungary
Soroka Medical Center-Hematology Department ( Site 0523)
Beersheba
8410101
Israel
Rambam Health Care Campus ( Site 0526)
Haifa
3109601
Israel
Hadassah Medical Center ( Site 0522)
Jerusalem
9112001
Israel
Sheba Medical Center-Hemato Oncology ( Site 0524)
Ramat Gan
5262100
Israel
Sourasky Medical Center ( Site 0525)
Tel Aviv
64239
Israel
Fondazione Policlinico Universitario Agostino Gemelli-ISTITUTO DI EMATOLOGIA ( Site 0383)
Rome
Lazio
00168
Italy
Azienda Ospedaliera Spedali Civili di Brescia-Hemathology ( Site 0400)
Brescia
Lombardy
25123
Italy
Ospedale San Raffaele-Unità Linfomi ( Site 0382)
Milan
Lombardy
20132
Italy
Policlinico S. Orsola- Malpighi-Istituto di Ematologia "L. e A. Seragnoli" ( Site 0381)
Bologna
40138
Italy
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku ( Site
Wrocaw
Lower Silesian Voivodeship
50-556
Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( S
Warsaw
Masovian Voivodeship
02-781
Poland
Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 0424)
Gdansk
Pomeranian Voivodeship
80-214
Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0427)
Gliwice
Silesian Voivodeship
44-101
Poland
GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 0548)
Ufa
Baskortostan, Respublika
450054
Russia
Almazov National Medical Research Centre-Intensive care unit No. 10 for oncohematological patients (
Saint Petersburg
Leningradskaya Oblast'
197341
Russia
Moscow City Clinical Hospital S.P. Botkin ( Site 0547)
Moscow
Moscow
125284
Russia
Russian Scientific Research Institute of Hematology and Blood Transfusion-Hematology ( Site 0542)
Saint Petersburg
Sankt-Peterburg
191024
Russia
Instituto Catalan de Oncologia - Hospital Duran i Reynals-Haematology Department ( Site 0442)
L'Hospitalet Del Llobregat
Barcelona
08908
Spain
Clinica Universidad de Navarra ( Site 0444)
Pamplona
Navarre
31008
Spain
Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 0446)
Madrid
28040
Spain
Hospital Universitario de Salamanca-Hematology ( Site 0441)
Salamanca
37007
Spain
Chang Gung Memorial Hospital at Kaohsiung ( Site 0263)
Kaohsiung Niao Sung Dist
Kaohsiung
83301
Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0262)
Taoyuan
333
Taiwan
Ege University Medicine of Faculty ( Site 0565)
Bornova
İzmir
35100
Turkey (Türkiye)
Ankara University Hospital Cebeci ( Site 0561)
Ankara
06100
Turkey (Türkiye)
Mega Medipol-Hematology ( Site 0567)
Istanbul
34214
Turkey (Türkiye)
Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 0562)
Istanbul
34365
Turkey (Türkiye)
Dokuz Eylül Üniversitesi-Hematology ( Site 0563)
Izmir
35340
Turkey (Türkiye)
Ondokuz Mayıs Universitesi ( Site 0564)
Samsun
55139
Turkey (Türkiye)
Cherkasy Regional Oncology Dispensary ( Site 0593)
Cherkassy
Cherkasy Oblast
18009
Ukraine
National Cancer Institute ( Site 0585)
Kyiv
Kyivska Oblast
03022
Ukraine
Institute of Transfusion Medicine and Blood of the National Academy of Medical Sciences of Ukraine (
Lviv
Lviv Oblast
79044
Ukraine
National Research Center for Radiation Medicine of National Academy of Medical Sciences of Ukraine (
Kyiv
Ukraine
FG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
FG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
FG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
FG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
FG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
FG00042 subjects
FG00142 subjects
FG00220 subjects
FG00330 subjects
FG00425 subjects
FG00533 subjects
Treated
FG00042 subjects
FG00142 subjects
FG00220 subjects
FG00330 subjects
FG00425 subjects
FG00532 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00042 subjects
FG00142 subjects
FG00220 subjects
FG00330 subjects
FG00425 subjects
FG00533 subjects
Type
Comment
Reasons
Death
FG00014 subjects
FG00110 subjects
FG0028 subjects
FG00322 subjects
FG00413 subjects
FG00515 subjects
Lost to Follow-up
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Sponsor decision
FG00026 subjects
FG00126 subjects
FG00210 subjects
FG0035 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0033 subjects
FG004
Site terminated by sponsor
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
BG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
BG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
BG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
BG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
BG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00042
BG00142
BG00220
BG00330
BG00425
BG00533
BG006192
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
BG00041.5± 16.5
BG00146.7± 17.6
BG00263.6± 12.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00018
BG00116
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0006
BG0013
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
Percentage of Participants With a Dose-Limiting Toxicity (DLT)
A DLT is defined as an event with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment that are not due to pre-existing conditions as defined by the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE 5.0). Percentage of participants who experience a DLT per CTCAE 5.0 are reported.
All participants who received at least one dose of study intervention and that finished the DLT evaluation period without a DLT or experienced a DLT in the DLT evaluation period.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 6 weeks
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG00042
OG00141
OG00218
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.8(0.8 to 14.2)
OG0012.4(0.1 to 10.8)
OG0020.0(0.0 to 14.6)
OG003
Primary
Percentage of Participants Who Experienced an Adverse Event (AE)
An AE is any unfavorable and unintended sign, 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 is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants who experience an AE are reported.
All allocated participants who received at least 1 dose of study intervention.
Posted
Number
Percentage of Participants
Up to approximately 27 months
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Primary
Percentage of Participants Who Discontinued Study Treatment Due to an AE
An AE is any unfavorable and unintended sign, 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 is temporally associated with the use of the Sponsor's product, is also an adverse event. The number of participants discontinued from the study treatment due to an AE are reported.
All allocated participants who received at least 1 dose of study intervention.
Posted
Number
Percentage of Participants
Up to approximately 24 months
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Secondary
Objective Response Rate (ORR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)
ORR for Cohorts A-D and F was assessed based on the Lugano 2014 Classification. ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and was evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). ORR for Cohorts A-D and F is presented. Cohort E is presented separately.
All participants who have received at least one dose of study intervention and had ORR measured by Lugano 2014 Classification.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 37 months
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Secondary
ORR as Assessed by the 2016 International Myeloma Working Group (IMWG) Response Criteria (Cohort E)
ORR for Cohort E was measured by 2016 IMWG Response Criteria. ORR is 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) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The ORR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.
All participants who have received at least one dose of study intervention and had ORR measured by the 2016 IMWG Response Criteria.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 37 months
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Secondary
Duration of Response (DOR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)
For participants who demonstrate a confirmed complete response (CR) or partial response (PR), DOR is defined as the time from CR or PR to documented disease progression or death. Participants are assessed using computed tomography (CT) and positron emission tomography (PET)- CT and response was evaluated based on the Lugano 2014 Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose [FDG] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters (SPD) for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). DOR for Cohorts A-D and F are presented. Cohort E is presented separately.
All participants who have received at least one dose of study intervention and had a response measured by measured by Lugano 2014 Classification.
Posted
Median
95% Confidence Interval
Months
Up to approximately 37 months
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Secondary
DOR as Assessed by 2016 IMWG Response Criteria (Cohort E)
DOR is defined as the time from CR or PR to documented disease progression or death. DOR for Cohort E was measured by the 2016 IMWG Response Criteria with response criteria defined as participants with either a stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. The DOR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.
All participants who have received at least one dose of study intervention and had a response measured by measured by 2016 IMWG Response Criteria. No participants met the pre-specified analysis criteria for DOR in Cohort E (i.e., no participants with a response) and therefore DOR is unavailable for Cohort E.
Posted
Up to approximately 37 months
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Secondary
Disease Control Rate (DCR) as Assessed by Lugano 2014 Classification (Cohorts A-D & F)
DCR is % of participants who had tumor response per response criteria or have stable disease (SD) for ≥ 12 weeks before any evidence of progressive disease (PD). CR or PR were evaluated with CT and PET-CT. CR: complete metabolic (no/minimal FDG uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. PR: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by >50% in length beyond normal). SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. DCR for Cohorts A-D & F are presented. Cohort E is presented in a separate outcome measure.
All participants who have received at least one dose of study intervention and were evaluated using Lugano 2014 Classification.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 37 months
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Secondary
DCR as Assessed by 2016 IMWG Response Criteria (Cohort E)
DCR: percentage of participants who have achieved tumor response or have shown SD for at least 12 weeks before any evidence of PD per IMWG response criteria 2016. Response criteria are defined as participants with either a sCR, CR, VGPR, or PR. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND <5% plasmacytomas in the bone marrow; sCR=CR as above PLUS normal serum FLC assay ratio and absence of clonal cells in bone marrow; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component <100 mg/24 hr; PR = ≥50% reduction of serum Mprotein and reduction in 24-hour urinary M-protein by ≥90% or to <200 mg/24 hours. SD = Not meeting criteria for CR, VGPR, PR, or PD. PD as defined by prespecified 2016 IMWG response criteria. DCR for Cohort E is presented. Cohorts A-D and F were presented in a previous outcome measure.
All participants who have received at least one dose of study intervention and were evaluated using 2016 IMWG Response Criteria.
Posted
Number
95% Confidence Interval
Percentage of Participants
Up to approximately 37 months
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Secondary
Lowest Plasma Concentration (Ctrough) of Vibostolimab
Ctrough is the lowest concentration reached by a drug before the next dose is administered. Blood samples collected predose were used to determine Ctrough of Vibostolimab.
All participants who received at least one dose of intervention and had data for the corresponding cycle.
Posted
Geometric Mean
95% Confidence Interval
ug/mL
Predose at Cycles 1, 3, 7, 11, 15, 19, 23, 27 and 31. Cycle = 3 weeks
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Secondary
Maximum Concentration (Cmax) of Vibostolimab
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected post dose were used to determine Cmax of Vibostolimab.
All participants who received at least one dose of intervention and had data for the corresponding cycle.
Posted
Geometric Mean
95% Confidence Interval
ug/mL
Postdose: after end of infusion (up to ~10 minutes) at Cycles 1 and 8. Cycle = 3 weeks
ID
Title
Description
OG000
Cohort A Pembrolizumab/Vibostolimab Coformulation
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Time Frame
Up to ~37 months.
Description
All-cause mortality: All allocated participants. Safety: All allocated participants who received at least 1 dose of study intervention. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
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 A
Participants with classic Hodgkin's lymphoma (cHL) or primary mediastinal B-cell lymphoma (PMBCL) who are relapsed or refractory to at least 1 line of prior therapy (cHL) of at least 2 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
14
42
17
42
35
42
EG001
COHORT B
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
10
42
11
42
39
42
EG002
COHORT C
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
9
20
8
20
15
20
EG003
COHORT D
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
24
30
11
30
21
30
EG004
COHORT E
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
14
25
8
25
16
25
EG005
COHORT F
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
15
33
13
32
24
32
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG0030 events0 affected30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Acute cardiac event
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Arrhythmia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Cardiac failure acute
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Myocarditis
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Pyloric stenosis
Congenital, familial and genetic disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Tracheo-oesophageal fistula
Congenital, familial and genetic disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Thyroiditis
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Gastric haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Immune-mediated gastritis
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Oesophageal haemorrhage
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Asthenia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Cytokine release syndrome
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Infusion related hypersensitivity reaction
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Acute hepatitis B
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Aspergillus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0011 events1 affected42 at risk
EG0023 events2 affected20 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Device related infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Encephalitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0012 events2 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Post-acute COVID-19 syndrome
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Sepsis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Soft tissue infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Vascular device infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Wound infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
High-grade B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Leydig cell tumour of the testis
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Neurological symptom
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Neurotoxicity
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Seizure
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Hydronephrosis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Nephritis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Oesophagobronchial fistula
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Toxic epidermal necrolysis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Embolism
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0007 events5 affected42 at risk
EG0016 events5 affected42 at risk
EG0021 events1 affected20 at risk
EG0035 events5 affected30 at risk
EG0048 events7 affected25 at risk
EG0055 events4 affected32 at risk
Eosinophilia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0008 events4 affected42 at risk
EG0010 events0 affected42 at risk
EG0023 events3 affected20 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0003 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Sinus tachycardia
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG00013 events8 affected42 at risk
EG0013 events3 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected42 at risk
EG0012 events2 affected42 at risk
EG0022 events2 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0007 events7 affected42 at risk
EG0015 events4 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected42 at risk
EG0011 events1 affected42 at risk
EG0022 events2 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Chills
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0014 events4 affected42 at risk
EG0022 events2 affected20 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected42 at risk
EG0016 events6 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Hyperthermia
General disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Influenza like illness
General disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0008 events8 affected42 at risk
EG00110 events7 affected42 at risk
EG0020 events0 affected20 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected42 at risk
EG0018 events7 affected42 at risk
EG0022 events2 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0013 events3 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0007 events6 affected42 at risk
EG0013 events3 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected42 at risk
EG0013 events2 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0005 events5 affected42 at risk
EG0013 events3 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0006 events5 affected42 at risk
EG0013 events3 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0005 events2 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0005 events3 affected42 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected20 at risk
EG003
C-reactive protein increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Neutrophil count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0005 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Platelet count decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0013 events3 affected42 at risk
EG0022 events2 affected20 at risk
EG003
Weight decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected42 at risk
EG0012 events2 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0013 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Hypernatraemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 27.1
Systematic Assessment
EG0002 events1 affected42 at risk
EG0015 events4 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events3 affected42 at risk
EG0013 events2 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0003 events2 affected42 at risk
EG0012 events2 affected42 at risk
EG0022 events2 affected20 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0004 events3 affected42 at risk
EG0014 events4 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected42 at risk
EG0011 events1 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0004 events4 affected42 at risk
EG0012 events2 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0005 events3 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0010 events0 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0013 events3 affected42 at risk
EG0020 events0 affected20 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG00014 events13 affected42 at risk
EG00113 events8 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected42 at risk
EG0015 events5 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0002 events2 affected42 at risk
EG0012 events2 affected42 at risk
EG0022 events2 affected20 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected42 at risk
EG0011 events1 affected42 at risk
EG0021 events1 affected20 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
Point of Contact
Title
Organization
Phone
Extension
Email
Senior Vice President, Global Clinical Development
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG00042
OG00142
OG00220
OG00330
OG00425
OG00532
Title
Denominators
Categories
Title
Measurements
OG00092.9
OG00197.6
OG00295.0
OG00380.0
OG00480.0
OG00587.5
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG00042
OG00142
OG00220
OG00330
OG00425
OG00532
Title
Denominators
Categories
Title
Measurements
OG00019.0
OG0014.8
OG00215.0
OG00313.3
OG0044.0
OG00512.5
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG00042
OG00142
OG00220
OG00330
OG0040
OG00532
Title
Denominators
Categories
Title
Measurements
OG00064.3(48.0 to 78.4)
OG00135.7(21.6 to 52.0)
OG00215.0(3.2 to 37.9)
OG00316.7(5.6 to 34.7)
OG00518.8(7.2 to 36.4)
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG00425
OG0050
Title
Denominators
Categories
Title
Measurements
OG0040.0(0.0 to 13.7)
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG00027
OG00115
OG0023
OG0035
OG0040
OG0056
Title
Denominators
Categories
Title
Measurements
OG0005.4(2.9 to 11.00)
OG0013.0(2.8 to 10.2)
OG0022.8(2.8 to NA)NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG003NA(2.9 to NA)NA = Median and upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG0053.4(1.6 to NA)NA = upper limit not reached at time of data cut-off due to insufficient number of responding participants with relapse.
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG00042
OG00142
OG00220
OG00330
OG0040
OG00532
Title
Denominators
Categories
Title
Measurements
OG00073.8(58.0 to 86.1)
OG00159.5(43.3 to 74.4)
OG00225.0(8.7 to 49.1)
OG00316.7(5.6 to 34.7)
OG00531.3(16.1 to 50.0)
OG001
Cohort B Pembrolizumab/Vibostolimab Coformulation
Participants with cHL or PMBCL who are relapsed or refractory to at least 2 lines of prior therapies (cHL) of at least 3 lines of prior therapies (PMBCL) received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG00425
OG0050
Title
Denominators
Categories
Title
Measurements
OG00416.0(4.5 to 36.1)
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG00035
OG00140
OG00218
OG00318
OG00425
OG00525
Title
Denominators
Categories
Cycle 1
ParticipantsOG00035
ParticipantsOG00140
ParticipantsOG00218
ParticipantsOG00318
ParticipantsOG00425
ParticipantsOG00525
Title
Measurements
OG0008.06(6.71 to 9.68)
OG0019.86(8.22 to 11.8)
OG00210.0(6.61 to 15.3)
OG003
Cycle 3
ParticipantsOG00034
ParticipantsOG00137
ParticipantsOG00214
ParticipantsOG00310
Cycle 7
ParticipantsOG00026
ParticipantsOG00127
ParticipantsOG0023
ParticipantsOG0033
Cycle 11
ParticipantsOG00014
ParticipantsOG00113
ParticipantsOG0022
ParticipantsOG0032
Cycle 15
ParticipantsOG00011
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0032
Cycle 19
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0032
Cycle 23
ParticipantsOG0004
ParticipantsOG0016
ParticipantsOG0020
ParticipantsOG0031
Cycle 27
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG0020
ParticipantsOG0032
Cycle 31
ParticipantsOG0002
ParticipantsOG0013
ParticipantsOG0020
ParticipantsOG0032
OG002
Cohort C Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory follicular lymphoma (FL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG003
Cohort D Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG004
Cohort E Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory multiple myeloma (MM) following at least 3 lines of therapy and have exhausted all approved lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
OG005
Cohort F Pembrolizumab/Vibostolimab Coformulation
Participants with relapsed or refractory non-Hodgkin's lymphoma (NHL) following at least 2 lines of therapy received pembrolizumab/vibostolimab (coformulation of 200 mg pembrolizumab and 200 mg vibostolimab) via intravenous IV infusion once every 3 weeks (Q3W) for up to 35 cycles up to approximately 2 years.
Units
Counts
Participants
OG00037
OG00138
OG00217
OG00326
OG00424
OG00528
Title
Denominators
Categories
Cycle 1
ParticipantsOG00037
ParticipantsOG00138
ParticipantsOG00217
ParticipantsOG00326
ParticipantsOG00424
ParticipantsOG00528
Title
Measurements
OG00085.8(65.4 to 113)
OG00185.4(70.0 to 104)
OG00242.6(35.2 to 51.5)
OG003
Cycle 8
ParticipantsOG00027
ParticipantsOG00127
ParticipantsOG0023
ParticipantsOG0033
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
2 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0051 events1 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0042 events2 affected25 at risk
EG0052 events2 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0052 events2 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0042 events2 affected25 at risk
EG0050 events0 affected32 at risk
4 events
4 affected
30 at risk
EG0041 events1 affected25 at risk
EG0055 events5 affected32 at risk
3 events
2 affected
30 at risk
EG0043 events3 affected25 at risk
EG0054 events4 affected32 at risk
0 events
0 affected
30 at risk
EG0044 events2 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0052 events2 affected32 at risk
1 events
1 affected
30 at risk
EG0042 events1 affected25 at risk
EG0053 events2 affected32 at risk
4 events
4 affected
30 at risk
EG0040 events0 affected25 at risk
EG0053 events3 affected32 at risk
0 events
0 affected
30 at risk
EG0042 events2 affected25 at risk
EG0055 events5 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0052 events2 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
2 events
2 affected
30 at risk
EG0044 events4 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
8 events
4 affected
30 at risk
EG0044 events3 affected25 at risk
EG0056 events4 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0045 events3 affected25 at risk
EG0051 events1 affected32 at risk
1 events
1 affected
30 at risk
EG0042 events2 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0051 events1 affected32 at risk
4 events
2 affected
30 at risk
EG0042 events2 affected25 at risk
EG0051 events1 affected32 at risk
2 events
2 affected
30 at risk
EG0041 events1 affected25 at risk
EG0052 events1 affected32 at risk
1 events
1 affected
30 at risk
EG0043 events3 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0052 events2 affected32 at risk
3 events
3 affected
30 at risk
EG0044 events4 affected25 at risk
EG0052 events2 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0054 events4 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0052 events2 affected32 at risk
0 events
0 affected
30 at risk
EG0044 events3 affected25 at risk
EG0050 events0 affected32 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0044 events4 affected25 at risk
EG0051 events1 affected32 at risk
3 events
2 affected
30 at risk
EG0044 events4 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0042 events1 affected25 at risk
EG0053 events3 affected32 at risk
0 events
0 affected
30 at risk
EG0042 events2 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0043 events3 affected25 at risk
EG0051 events1 affected32 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
1 events
1 affected
30 at risk
EG0043 events2 affected25 at risk
EG0051 events1 affected32 at risk
1 events
1 affected
30 at risk
EG0042 events2 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0042 events2 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0042 events2 affected25 at risk
EG0050 events0 affected32 at risk
0 events
0 affected
30 at risk
EG0042 events2 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0042 events2 affected25 at risk
EG0054 events4 affected32 at risk
0 events
0 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
0 events
0 affected
30 at risk
EG0041 events1 affected25 at risk
EG0052 events2 affected32 at risk
0 events
0 affected
30 at risk
EG0043 events3 affected25 at risk
EG0050 events0 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
2 events
2 affected
30 at risk
EG0041 events1 affected25 at risk
EG0057 events7 affected32 at risk
2 events
2 affected
30 at risk
EG0040 events0 affected25 at risk
EG0053 events3 affected32 at risk
1 events
1 affected
30 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected32 at risk
1 events
1 affected
30 at risk
EG0043 events1 affected25 at risk
EG0052 events2 affected32 at risk
9.64
(7.24 to 12.9)
OG0049.86(6.52 to 14.9)
OG0059.52(6.95 to 13.0)
Participants
OG004
4
ParticipantsOG00517
Title
Measurements
OG00015.3(12.4 to 18.8)
OG00117.0(13.3 to 21.6)
OG00222.6(13.5 to 38.0)
OG00314.5(7.55 to 27.9)
OG00417.9(5.07 to 63.3)
OG00520.2(15.8 to 25.9)
Participants
OG004
0
ParticipantsOG0055
Title
Measurements
OG00021.0(17.1 to 25.8)
OG00119.5(14.9 to 25.5)
OG00238.1(6.15 to 236)
OG00325.8(5.19 to 129)
OG00522.1(14.1 to 34.7)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00022.6(16.6 to 30.8)
OG00124.2(16.3 to 35.8)
OG00228.9(0.251 to 3330)
OG00340.7(40.1 to 41.4)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00026.2(17.0 to 40.6)
OG00125.6(17.4 to 37.8)
OG00340.6(7.65 to 216)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00034.8(21.6 to 56.2)
OG00124.2(13.8 to 42.6)
OG00331.1(5.49 to 176)
Participants
OG004
0
ParticipantsOG0050
Title
Measurements
OG00036.5(24.2 to 55.2)
OG00124.8(15.2 to 40.3)
OG00351.5(NA to NA)Confidence interval cannot be calculated when N=1.